However, to create a truly digital lab, it is not enough to implement advanced technologies, but a thoughtful balance between the people, processes and systems that form the basis of lab operations is required.

This special session at the 12th edition of the PLA® Conference Europe (March, Milan) will address the many challenges encountered on the road to digitalisation. From user adoption and adapting organisational culture to rethinking processes for maximum efficiency and ensuring that systems, instruments and data streams— are seamlessly connected, every aspect is critical to success.

We would like to thank Bob McDowall, Christine Mladek and Jens Donath for leading this session with strong presentations, followed by a panel discussion moderated by Isabel Muñoz-Willery.

Digitalisation & Strategy for Interfacing

Christine Mladek, Head of Global QC Network Management at Boehringer Ingelheim will share her extensive experience about cooperating and collaborating for successful digitalisation projects.

The digitalisation of quality control laboratories requires effective communication and collaboration between IT, Quality Management and Users.  This collaborative approach ensures alignment on project timelines, optimises resource utilisation, minimises transition tome, streamlines implementation and promotes continual improvement. Key factors for success include adherence to lab equipment standards, process standardisation, user-adapted trainings, submission changes and behavioural transformation.  Support from management, process/system owners and a robust governance structure are essential for the successful transformation.

People at the Core: Overcoming challenges and unlocking opportunities in digital lab transformation

Jens Donath, Head Project Management Quality at Lonza will highlight the critical role of people in achieving a successful transition to a paperless lab. He will  emphasizes the importance of managing both end-users and technical project teams, addressing resistance to change, cultural shifts, and the need for skill development. Focus is given to ensuring collaboration between the operational and technical teams.

The impact of Regulations and Data Integrity guidance on process redesign

Bob McDowall, Director at R D McDowall Ltd, will focus his presentation on the regulatory compliance aspect of digitisation projects.

When digitalising a regulated laboratory, understanding and simplifying a process is key to unlocking business benefits. However, any redesigned process must ensure that applicable regulations and data integrity guidance documents are complid with. This starts with ensuring that each application selected has the functionality to automate the process and ensure integrity of the records acquired, processed and reported.

How to adopt new Technologies and remain Compliant

To conclude the three presentations, the panel discussion, moderated by Isabel Muñoz-Willery, Ph.D., Owner and Event Director of PLA® Conferences, will continue the discussion and engage with the audience on how to avoid being overwhelmed by compliance requirements while adopting the latest technologies.

Join us as we explore best practises, real-world case studies and actionable strategies for overcoming these hurdles. Whether you are just starting to digitise your lab or looking to refine and optimise your existing efforts, this session will provide valuable insights to help you drive transformation with confidence.

Let’s reinvent the future of labs together — where digitalisation is not a challenge, but an opportunity.

Follow us to stay informed about all the other sessions we are preparing with thought leaders from Roche Diagnostics, Lonza, Menarini, Esteve, Walloon Agricultural Research Centre and others.

Save your free place and register now!

The post Meeting the Challenges of People, Process and Interfacing When Digitalising Labs appeared first on .

In fact, when it comes to digitising R&D and QC lab processes that operate in regulated environments, discussions start (or better, should start) with how to properly manage the data generated in the labs. On the list of requirements set by the project stakeholders, compliance with industry regulations is certainly one of them and the measures to be taken are an essential part of the project plan.
Precisely because it is so important, discussions on quality are addressed in a special session at the #PLA2023USA consisting of presentations delivered by internationally recognised experts and followed by a panel discussion to further deepen the conversation with participants.

Defining the Quality Culture

We will talk about risk management, computer software validation and data integrity, but… this will not be a training session on concepts or an endless list of guidelines… this session will mainly deal with the concept of quality culture within an organisation and how to ensure appropriate behaviour of all components of the group.

In the search for a definition of culture, every anthropologist has a slightly different view of what culture means. However, there are common elements in answering the question of what culture encompasses. Culture is the holistic combination of learned and shared beliefs, values and practises that create cohesion in a group.

The employees of a company thus form a group that works and acts in the way they believe is expected of their company, or better still, in the way expected of everyone role and responsibility.

For this very special session, we are honoured to have as guests three internationally renowned experts who will share their experiences and use cases and lead us to a concluding Panel Discussion on challenging the paradigm of getting things done just for the sake of the next audit. Provocative but healthy and certainly respectful discussions.

Discussing Quality with our international keynote speakers

Mark Newton, owner at Heartland QA, will address the delicate topic of balancing business needs with compliance gaps. It is important that compliance remains a function that is judged on how it supports the business. However, it is important that the business understands how important quality requirements, and therefore compliance, are to the success of the business itself. Mark will take us in his presentation from his 30+ years at Eli Lilly as an Associate Quality Assurance Senior Consultant and his great contribution as co-editor of several GAMP guides.

Chinmoy Roy, CSV and Data Integrity SME, Independent Consultant, will develop further about the approach to data integrity risk management using data integrity maturity model and process mapping. He will also bring a case study about conducting DI risk assessment in a QC laboratory.
Chinmoy is a biopharmaceutical consultant with over 40 years of experience in CSV, Data Integrity, 21 CFR Part 11, Annex 11 and manufacturing process automation. His presentations blend his field experience to highlight the intricacies of implementing regulations

George Bernstein, Ph.D., President of MAI Consulting, will then focus largely on the human factor in the compliance execution: the Data integrity wild card. George has a Ph.D. in Chemical Engineering and over 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. In his presentation, George will touch upon the opportunities and human factors that lead to data integrity breeches, and strategies to further mitigate that risk.

“We have engineering and software solutions to reduce opportunities for data integrity breech, but these are applicable for some but not all areas of exposure. Use of legacy equipment, logbooks, and manual entry into batch records requires training and QA oversight to minimize data integrity risk. Unfortunately, training is often ineffective, and QA staffing may be in short supply.” commented George during our interview.

Following these 3 master presentations, the panel discussion will be used to discuss the next steps for your projects.

Invitation to #PLA2023USA

Mark, Chinmoy and George are far more than senior advisors who can identify problems and potential root cause when they visit a customer site. They are independent voices with a strong desire to close the gaps identified with their clients.

Open and honest, they will tell you their truth. Whether you like it or not, no one is left untouched by what they have to say, based on their vast experience in the field and their vision from international exposure.

Whether your laboratory operates in a highly regulated environment such as the pharmaceutical, but also the forensic or the cannabis industry, whether your laboratory is dedicated to research and development or quality control… Quality is not only a matter of compliance, but also a matter of business success.

Join the discussions at the Paperless Lab Academy® 2023 USA!

Get your free pass! REGISTER NOW *

Mark Newton has been employed for 33+ years by Eli Lilly and Company in several cross-functional roles.  Starting as a Microbiologist, he spent 14 years within the chemical, pharmacological, and microbiological areas of QC Laboratories as an analyst, method developer and supervisor.  The balance of his career has been within IT and Quality, implementing GMP software, serving as computer system QA, then a Laboratory Data QA representative, developing standards for qualification of laboratory computerized systems and training lab personnel in data integrity auditing, gap identification and remediation techniques.
He is co-editor of the GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (2nd ed), and currently co-leader of the GAMP Data Integrity Special Interest Group (SIG) and the ISPE Global Documents Committee.  He has recent publications in Pharmaceutical Engineering, Scientific Computing and the ISPE Blog (ISPEAK).

Chinmoy Roy, CSV and Data Integrity SME, Independent Consultant. Chinmoy Roy is a biopharmaceutical consultant with over 40 years of experience in CSV, Data Integrity, 21 CFR Part 11, Annex 11and manufacturing process automation. He was one of the architects for designing and implementing the largest paperless biologics manufacturing plant in the world. He was a member of ISPE’s Data Integrity Special Interest Group (S.I.G). He travels the world to train industry personnel in the areas of his subject matter expertise of CSV and Data Integrity as well as to conduct data integrity audits…
Chinmoy has a bachelor’s degree in electrical engineering and a master’s degree in computer science.

George Bernstein, Ph.D., is President of MAI Consulting. He has a Ph.D. in Chemical Engineering and over 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. Since 1988, Dr. Bernstein has consulted both nationally and internationally with major pharmaceutical companies to address compliance actions by Health Authorities. He has lectured internationally on quality systems and root cause analysis to industry trade groups, quality organizations, and at PDA and Interphex conferences. Dr. Bernstein’s experience, insights, and innovative problem solving have been integral to his work which ranges from training effectiveness, GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with the US FDA.

The post PLA2023USA: Quality Production relies on Fundamental Quality Culture appeared first on .

Program your own educational program

You are welcome to access to each and every session. The full list of available session from the academy are to be find at @academywebinarprogram.   The sessions are recorded and available on demand.

Academy Webinar: Journey to a Digitally Transformed Laboratory 

This Academy Webinar from Thermo Fisher Scientific  discusses about how to develop a realistic strategy for your digital projects.

Across all scientific industries, organizations are looking at their digital transformation journey and trying to map out the key strategies to achieving a fully digitally enabled laboratory. The key to creating and implementing a digital strategy is determining where efficiencies can be made and where technologies can provide a competitive edge.

Looking at the most recent technological advancements, and those yet to come, organizations need to understand where they are in their digital transformation journey and how they can continue to move forward. Organizations are looking to implement more effective instrument connectivity, advanced software that can streamline processes, and tools and techniques to increase data efficiency.

Whether you are just starting to implement a strategy or are almost a fully digital laboratory, it is important to look at your current data infrastructure and your laboratory needs to develop a realistic strategy. With expertise in integration, data visualization, services and software, Thermo Fisher Scientific can help. Join the upcoming webinar to learn how to build a strategy that makes sense for your laboratory.

Academy Webinar: How to easily find and access your documents anywhere, anytime 

A presentation from DEXSTR that demonstrate about finding your data instead of desperately searching them.

With the explosion of data volumes collected, the ability to process it becomes a real challenge.

To address this challenge, DEXSTR presents their new offer Inquiro lite. They discuss about how to Easily find your data and retrieve your siloed data from one single location.  You’ll improve your productivity by leveraging your untapped data, increase the global collaboration efficiency by sharing data in information-driven manner and monitor your data by creating your own dashboards

Academy Webinar: Data Review in the laboratories of the pharma industry

A presentation from Inpharmatic about the benefits of a paperless scenario for raw data, with or without a LIMS.

The final version of the guideline PI 041-1 (1 July 2021) “GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS” details the Authorities’ expectations for the Review of electronic data (§9.8).

Based on this guideline, during the webinar we will talk about the importance of data review in the data lifecycle, how to be compliant with data integrity requirements and the essential checks to perform during a data review. like, consistency between data on the notebook/analytical worksheet and analytical request/order, validity of used reagents or accessories, availability of Raw data, etc

We will also make a comparison between the current paper-based data review and the electronic data review and will give participants important advice to improve the efficiency and the effectiveness of the review.

This include the benefits of Exception Reports: validated search tools that identify and document predetermined “abnormal” data or actions, which require further attention or investigation by the data reviewer.

More webinars are available at #academywebinarsprogram   

The post Academy Webinars Fall Program: Journey to digitally transformed laboratory appeared first on .

Program your own summer educational program

You are welcome to access to each and every session. The full list of available session from the academy are to be find at @academywebinarprogram.   Below examples of you can find in the Academy webinars program

Academy Webinar: Planning a Tomorrow-Ready QC Lab with Caliber Technologies 

This Academy Webinar from Caliber discusses the critical digital changes to be brought in to the QC lab to make it Tomorrow Ready. At present, Pharma companies follow a standard approach towards the tools they implement and envision for their lab. The focus is still limited to removing paper-related obstacles and reaping a finite number of short-term benefits. But there can be more to lab digitalisation. A paradigm shift in approach is needed to make lab digitalisation more sustainable by adopting futuristic tools for predictive analysis, ensuring that the lab meets quality and productivity KPIs and generate better return of investment recognition in a QC lab.

Academy Webinar: Lab Efficiency and Data Integrity with Empower PLUS Solutions with Waters Corporation

A presentation from Waters that demonstrate how much more you can do with the systems you already have and how to plan for phased implementations and incremental extensions to automate your laboratory workflow. Many companies are not using all of the available functionality in their existing systems and you may be able to do a lot more with what you already have in place, or with small incremental expansions. Many laboratories however may be working with a mixture of standalone workstation instrument PCs, paper lab books and small networks. A major new software implementation – for example, deploying a LIMS – would need:

• CRLF Significant time and effort from laboratory personnel while your analysts are busy trying to complete their routine tasks, sometimes with limited laboratory access,
• Tremendous IT support when most IT groups are busy managing remote access and overloaded VPNs, and
• Large capital investment at a time when many companies are struggling with much reduced revenues and reduced budgets

Academy Webinar: Digital Continuity from R&D to Manufacturing with Dassault Systèmes 

A Dassault Systèmes presentation about how BIOVIA solutions help CROs, CMOs and CDMOs achieve collaborative innovation & operational excellence through Digital Continuity. The presentation discuss the key that helps organisations attain Digital Continuity and transform:

• From Product to Experience, through multi-scale & multi-discipline support
• From document based and siloed designs to data-driven and model based approach
• From siloed organisations to Flexibility in a Global Company
• From Capacity Maximisation to Cycle Time Optimisation
• From process execution to real time business impact analysis
• From Transactional to more standardised regulatory dossiers & quality

Academy Webinar: Unleash your lab’s productivity with Merck 

Presentation from Merck about the opportunities to  improve productivity, compliance, and safety in laboratory management through digitalisation. 

• How many times have you tried pulling a chemical required for an experiment only to find that someone else from your lab has already taken it? Or that the chemical just expired and you now need to wait several days to receive a new supply?
• How much did you sweat in your last audit when the auditor asked about the documentation regarding  the usage of chemicals and reagents?
• Did you know that most laboratories spend 25% of their available working time on  the management and documentation of consumables, chemicals, reagents, and equipment?
• Why do we still accept compliance and safety risks by using paper or Excel-based data capture or data transfer?

In this session, you discover the opportunities to improve productivity, compliance, and safety in laboratory management through digitalisation.

Academy Webinar: Intelligent Automation in QC Management with Accenture

A presentation from Accenture about the new challenges faced in the Pharmaceutical Industry. Before the global pandemic, the industry was already facing problems of exploding drug development costs and increasingly complex supply chain and regulatory environments, as well as downward price pressure from generics, global health systems and outcome-based pricing models. The unprecedented challenges of the pandemic forcing remote work and demanding tests, vaccines and therapies at desperate speed, only add to the challenges. To date, Quality has throttled speed to market and been a necessary, but precious, cost. Today’s business cannot afford the reactive, manual and still largely paper-based Quality processes.

It is no longer enough to talk about digitalization and automation of antiquated Quality systems. It is now a business necessity to shift the Quality paradigm. Companies need to reduce the cost of Quality and increase the speed, efficiency, and reliability of our processes.

More recorded webinars are available at @academywebinarsprogram  

The post Academy Webinars Summer program appeared first on .

Join the LabVantage Webinar Serie

LabVantage is pleased to invite you to join our upcoming webinars

SAAS Cloud Solution

LabVantage SaaS provides effortless and cost-effective access to an integrated lab informatics suite with Laboratory Information Management System (LIMS), Electronic Lab Notebook (ELN), Lab Execution System (LES), and Scientific Data Management System (SDMS).

LabVantage Analytics

LabVantage Analytics delivers a solid foundation for your analytics journey from Descriptive Analytics to Predictive and Prescriptive Analytics. Coupled with targeted solution-centric professional services, LabVantage delivers value to various business roles one encounters in a typical enterprise.

LabVantage Covid-19 Accelerator

Complete Biobank LIMS solution with OMICS workflows, CDC Test Methods, Management of Consumables and many other features

LabVantage ELN & LES

Our powerful, fully integrated platform for your lab to eliminate unnecessary paper records

LV Express

The ideal solution for smaller Quality Control or Contract/Analytical Testing labs that have, or want, pre-determined, standard process to meet high quality and accreditation requirements.

LabVantage 8.5 Overview

LabVantage 8.5 integrates new fonctionnalities such as Scientic Data Management System (SDMS) and configuration management tool (CMT) and much more improvements to be announced.   

Join us to enjoy Live presentations with Labvantage experts and click to register 

Covid-19 Accelerator – 7 July 2020

LabVantage ELN & LES – 9 July 2020

LV Express – 15 July 2020

LabVantage 8.5 Overview – 17 July 2020

SAAS Cloud Solution – 21 July 2020

LabVantage Analytics – 23 July 2020

The post LabVantage Webinar Series appeared first on .

The QC laboratories work in a highly regulated environment where effective electronic data management processes ensuring Integrity are a must. Therefore, these processes are still largely based on paper, preventing efficiency improvements that could be really useful.

The renewed attention of the authorities inspectors to the Data Integrity is pushing towards the management of instruments GMP data output in their original electronic format, preserving their contextualization (meta-data), any exceptions, quality control records and, in some cases, the Dynamic format that allows the data processing, including the re-evaluation of results or the execution of queries.

But the retention of data in electronic format has some pitfall. As an example, most of the software that manage analytical instruments do not provide any mechanism to record the data review by means of an electronic signature. While the GMPs require to document the data review.

The review in electronic format is available only on the most advanced platforms for Chromatographic Data Management System, for HPLC or GC. Simple instruments (ph-meters, scales, legacy instruments, etc) and also UV or IT spectrometers, titrators, densimeters, etc. do not support the electronic review, therefore the results are often printed in order to collect the signatures for the review.

With Ioi it’s possible to carry out the electronic review using electronic signatures and increasing the lab efficiency.

Electronic Review by Ioi – Integration of instruments

This feature, improved in the version 2.0 of the system, is designed to automate a business process This involves capturing what has been acquired by the field (measurement, notes, signature, contextualization, etc.) so that a reviewer can retrieve the electronic data to analyse and review for the final approval, through electronic signature, in a fully paperless process.

The new release of Ioi – Integration of instruments offers a fully paperless Electronic Review feature for almost all the data acquired, generated and processed. Based on the fact that this amount of collected data needs to follow a specific review flow, Ioi supports the Electronic Review feature to accomplish the whole life-cycle of every measurement and each meta-data related to it.

This functionality allows to carry out:

• Electronic Review configuration
• Measurements Review based on a configured contextualization
• Ioi Audit Trail Review
• Instrument Logbook Review

Measurements Review can be configured to meet the customer procedure. In this way, review permissions need to be associated to the reviewer role to let him/her access to such a process.

Ioi supports electronic signatures, which are required by the system for some specific actions, such as confirmation or rejection of a measurement or a performed review.

Ioi can be used in two different scenarios.

• A “less-paper” scenario, where at the end of the measurement and review process, Ioi is used to generate any required report (including the review), such as:
  • Measures Review notes and signature
  • Sample\Analysis sheet master container approval cycle
  • Instrument Logbook review details
  • Audit Trail review details
• A paperless scenario, where Ioi can transfer the results to an upper level system (LIMS, ELN, etc.). In this scenario it could be possible to interface the instruments directly to the LIMS or ELN, but each instrument would require a specific interface. Instead, Ioi can be quickly interfaced to the whole instrumentation and to the LIMS/ELN with a single interface.

In both cases, the original data are retained on Ioi.

Ioi – Integration of instruments goals… we haven’t forgotten the Data Integrity

Along with the electronic data management, the integrity of data is also crucial. Ioi – Integration of instruments, designed on the concepts of security, reliability and robustness of data. It represents the ideal starting point to achieve concrete Data Integrity-compliant results in the lab.

In conclusion, Ioi achieve these main goals:

• guarantee the Data Integrity compliance
• increase the process reliability reducing manual transcriptions
• improve lab efficiency optimizing the business processes (up to 50% of time saving)
• improve performances according to the regulations requirements
• enables a paperless, or at least a less-paper, lab

The Ioi application is fully validatable versus the requirements of FDA 21 CFR-11 and Annex 11 to European GMP (including Data integrity).

Quick installation of Ioi – Integration of instruments

Moreover, it’s quick installation (weeks) and simple management make it easy to realize typical lab processes without the complexity of projects such as ERP, LIMS or ELN. At the same time, Ioi does not replace these systems, but rather it gives its best when it’s placed between laboratory instruments and a LIMS (Laboratory Information Management System).

In case of a future ELN or LIMS implementation, the presence of a single interface thanks to Ioi, instead of an interface for each instrument, allows to preserve the investments.

Ioi is vendor-independent (all brands of instruments are interfaced) and is a web-based system.

If you want to know  all the capabilities of the Ioi Electronic Review feature , we invite you to contact us at info@inpharmatic.eu or visit our website www.inpharmatic.eu.

Emmanuele Dicerto, Chief Technology Officer at Inpharmatic

Inpharmatic is a team combining professionals with more than 25 years of experience in the pharmaceutical industry and a new generation of software designers, coordinated by project managers of international experience. The team aims to add the benefits of efficiency and integration to the systems compliance with the requirements of Data Integrity. In this way, investments in Data Integrity become a competitive advantage for the pharmaceutical industries. Inpharmatic is enlarging and structuring its organization in order to support the success of the proposed solution.

Gold sponsor at #PLA2021 , will be exhibiting and  Presenting a workshop ” Learn how to solve legacy instruments DI gaps with an instrument integration platform” 

The post ELECTRONIC REVIEW: easy to manage with Ioi – Integration of instruments appeared first on .

At present, in the labs, there are still “legacy” measuring instruments, i.e. instruments that are there since ever and very often they’re not fully compliant to Data Integrity requirements. Usually, the remediation of their Data Integrity gaps is an issue, because a compliant new instrument is either not available or, for any reason, the instrument cannot be substituted, or it is not worth a substitution.

In other cases, as a remediation activity, it is foreseen the installation of the vendor proprietary software that puts the instruments in compliance, but in this way several new software will be introduced in the lab. These ones require a specific validation exercise and the following administration activities, different passwords to remember for the analysts, etc.

Many alternatives try to solve the Data Integrity Gaps

Several powerful applications promise the benefits of instruments integration (LIMS, ELN…) and this seems to be for sure the best solution. But these applications require up-to-date instruments and complex projects to be implemented, in the meanwhile, DI gaps remain for months or even years.

As an alternative, the implementation of an integration platform, a middleware, can put the legacy instruments into compliance and can be the first step towards a full lab digitalization. Its quick installation and simple management make it the ideal starting point to achieve concrete DI-compliant results without the complexity of projects such as ERP, LIMS or ELN.

At the same time, this middleware does not replace these systems, but rather it gives its best when it is placed between laboratory instruments and a LIMS (Laboratory Information Management System).

Using this middleware integration platform, users have the opportunity to:

• Save time, digitalizing the entire process of measures acquisition;
• Review the measures;
• Become familiar with IT systems and better understand the potential and the critical issues of these
  ones, preparing themselves for more challenging projects and for the eventual achievement of a
  completely digitalized scenario.

Why Ioi, Integration of Instruments 

Ioi is a middleware platform that captures laboratory instrument measurements, overcoming the Data Integrity gaps of legacy (but also new) instruments by collecting all the necessary metadata: who did the measure, the date/time of the measure, the instrument ID, the sample ID, the measure engineering unit, etc.

In other words, Ioi digitalize the tickets, because it stores the measures and the related metadata in a secure database (SQL) in full compliance with Data Integrity and without any paperwork.

Preserve your investments by interfacing Ioi

From a practical viewpoint the operator, by the use of a tablet, can:

• Log into the system (also using the credentials of the company network);
• Identify the sample reading the sample ID;
• Identify the instrument automatically or reading the ID;
• Read automatically the measurement of the instrument;
• Sign electronically the measurement (where applicable);
• Time stamp the measure with date and time taken from the network.

Further, Ioi preserves your investments: since when you implement other systems, like LIMS or ELN, you integrate all instruments by interfacing Ioi (one single interface) instead of interfacing every single
instrument (several interfaces).

The platform is scalable, so it’s possible to add new instruments at any moment with a simple
configuration and validation (GAMP sw category 4 instead of scripts belonging to category 5).

Some additional advantages are:

• Centralized access management (the same access credentials applied to several instruments) with benefits for:
  Users: only one password to remember and to change in case of expiry;
  Administrator: only one account to setup for each user (also by network domain).
• Automatic time synchronization from the network;
• Automatic recording of the Sample/Batch ID;
• Automatic instrument logbook.

Gold sponsor at #PLA2020 , exhibiting and  Presenting a workshop ” Learn how to solve legacy instruments DI gaps with an instrument integration platform” at #PLA2020

Emmanuele Dicerto, Chief Technology Officer at Inpharmatic

 

 

 

 

The post How to solve legacy instruments Data Integrity gaps appeared first on .

Process capability – what has changed over the years?

The importance of process capability was highlighted when reviewing QC analytical records for a firm where the ability to generate an analytical value “right first time” was better 2-3 years ago than today.  Same method, same equipment, and even a few personnel added to the QC Lab.  So what changed?  Manufacturing output more than doubled over 3 years with more line extensions.  Manufacturing now produces more batches and more stability samples. Manufacturing capability improved, while the QC Lab capability did not; in fact, the equipment is now older and more likely to fail than before.  Out of date methods were not consistently able to generate values that could be released the first time, so rework (and investigations) began to take away from bench time.  A downward spiral of issues and investigations resulted in slipped schedules and unhappy customers, putting everyone on edge.

Process Capability and personnel pressures

When any process (purchasing, manufacturing, lab, calibration) is not sufficiently designed to work right the first time, every time at the timeliness of output demanded by customers, the outcome will be pressure applied to the organization. Personnel are tempted to falsify data or take improper shortcuts to “get it out the door” and relieve this pressure.  Culture can mitigate the situation by reminding people that honest reporting of data and issues is expected and supported by the organization.  That does not make the pressure go away—it is a temporary “escape valve” for that pressure.  Pressure is minimal when repeatable processes meet the demands.

Process Capability: the QC lab blind spot

Once the root cause –lack of capability—is understood, its application yields some immediate insights. First, labs are trouble spots for data integrity because they are rarely designed to be capable.  Yes, admit it.  Manufacturing processes are designed to a known quantity of output.  QC Labs, as a routine, are not.  From a data perspective, a QC Lab is a miniature production process with people, procedure steps, equipment, vessels, inputs and output (data). It can be modeled just like a manufacturing operation. The capability could be known.  But why is it so seldom done?

• There are many lab methods—several times more than manufacturing processes;
• QC Labs rarely have support specialists as do their Manufacturing counterparts: planners, equipment specialists, validation specialists, process design/engineering, IT, etc. Many QC Labs do all functions internally;
• Site leaders often have no insight into their QC Labs because their career progression did not include a QC Lab rotation.

The results are QC Labs with capabilities not matched to the Manufacturing operations they are tasked to support.

Process Capability: manufacturing’s moment of truth

Lack of capability can also impact Manufacturing operations.  Processes created under inflexible time constraints (e.g. first to file, exclusivity period) are at risk for this same issue.  These processes can lack the rigorous design space develop that assures a high probability of right first time.  This observation is consistent with the increased data integrity issues in generic firms where the perfect combination of low profit and timing pressures to file can result in manufacturing processes that can be validated but are not capable of “right first-time” outputs that keep a plant on schedule.

Death of the quality culture

An unintended consequence of non-capable processes is the death of the quality culture.  How?  Human nature kills it.  In developing a quality culture, personnel are told to “stand up and speak up” when there are issues.  Great.  If the voice is heard and a solution is developed, the issue is closed, and that complaint is no longer heard.  But process capability issues are more involved: they require development, validation, regulatory submission and approval.  This takes time and money; therefore, these issues will continue to be reported, week upon week, until the line supervisor says, “Enough! I hear you! Stop reporting that!” And here is the death of “stand up and speak up”—the boss just effectively said, “shut up and sit down”.  When issues exist that will require months to resolve, it is important to provide some means of keeping the issue visible to personnel, such as a workroom board.  The issue—and its estimated date of resolution—must be visible, to stop re-reporting, thereby frustrating line supervisors.  To keep “stand up and speak up” alive, the organization must deliver solutions to issues that hinder capability or human nature kills the culture.

Development – what is the root of the problem?

Little has been written about the link between Development/MS&T teams and data integrity in GMP operations, yet poorly developed processes add considerable pressure to GMP operations when they fail the “right first time, every time” standard.  There is a direct causal link between development/support practices and GMP conformance.  Your Development team has considerable influence over your data integrity pressures by the robustness of their efforts.

It is acknowledged that many methods are registered and can require considerable resources to update them.  This is where efforts like ICH Q14 (2) can help reduce the unnecessary regulatory burden that now impedes industry progress in adopting better analytical technologies.  At the same time, an assessment of time spent in additional testing, investigations, and documentation may conclude that the investment will be repaid in a short time period.  My former employer once estimated the time to write a deviation report at 40 hours.  That is probably a low estimate in today’s environment.

Looking for capability issues

Is lack of capability an issue in your organization?  There are questions and metrics that can provide insights to you:

* What is your site’s conformance to schedule? When operations routinely fail to meet the schedule is a lack of process capability the root issue?

* What is the “right-first-time” percentage for your various processes?  Is it near 100% or more like 80%? Each failure involves extra work by someone. There soon is a point where the extra work is better spent on a better process;

* Do you routinely have backlogs in any part of your process?  Instead of people issues, perhaps the issue is your process;

* Does a bottleneck remain even after people have been added?  This is a flag that the issue is not people, but rather process;

* If there have been productivity gains in one area of the operation, were supporting operations also improved at the same pace?  Or were they considered at all?

Linking Process Capability to Data Integrity

Based on such experiences, it is worthwhile to add a question when investigating data integrity issues in your organization:  Was a process-related deficiency a potential contributing factor to the issue?  It is too simple to blame data integrity failures on behaviors and ignore the source of the pressures that pushed them toward the undesired actions.

Eighty-five percent of the reasons for failure are deficiencies in the systems and process rather than the employee. The role of management is to change the process rather than badgering individuals to do better. – W. Edwards Deming

Process capability has a direct relationship to data integrity pressures. We need to consider process capabilities in all areas of the site to assure that pressures on our people are minimized, and people can focus on making safe, effective medicines that patients expect.

Special thank you to Bob McDowall (McDowall Consulting Ltd) for reviewing this document prior to submission.

References

• ISPE Cultural Excellence Report, April 2017. Available from ISPE (ispe.org)
• International Conference for Harmonization. Q14 Analytical Procedure Development (www.ich.org/page/quality-guidelines)

Mark E Newton, Heartland QA
Mark Newton is an independent consultant who specializes in data integrity, laboratory informatics, computer systems validation, and Quality. He has 35 years of experience in the pharmaceutical industry.
He can be contacted through LinkedIn:  linkedin.com/in/mark-newton-3848236

The post Process Capability: The Missing Element to Data Integrity appeared first on .

One of the most difficult types of systems to be put in compliance are simple tools, such as scales, pH meters, conductivity meters, etc.

For these tools, the guidelines consider acceptable that the data are printed on a receipt (static format), but recommend that the metadata, such as date and time and the identifier of the instrument, are also printed. Then the analyst must write down the reference to the sample, sign the print and fix it in his notebook or analytical sheet.

As a result, the date and time of the instrument must be synchronized and locked. Unfortunately, not all the tools have a password to limit the modification of date and time to an independent user. In this case, it is possible to replace the instrument with one protected by a password.  It is an expensive solution.  Even if renewing the tools is desirable, it is not always affordable or not for all instruments at the same time. However, even in the case of tools with a password, it is costly to manage these passwords procedurally and to synchronize the time (at least twice per year in order to switch to and from daylight saving time). Last but not least, it is time-consuming to attach the paper receipt (or any photocopies in case of thermal paper). This is an important inefficiency factor that could benefit from a paperless solution.

An alternative solution is a “middleware” like the Inpharmatic Integration of instruments (Ioi). This software is a sort of “wrapper” that adds-on to the measuring instrument taking care of the measurement metadata such as sample-id, date-time, operator identity, electronic signature (where applicable) …

From a practical viewpoint the operator, by means of a tablet, can: 
• Authenticate (also using the credentials of the company network)
• Read the sample number through a barcode or data matrix;
• Read automatically the measurement from the instrument;
• Sign electronically (where applicable)
• Take date and time automatically from the network

All these information are recorded in a secure DataBase (SQL), in full compliance with Data Integrity and without any paperwork to store the raw data.

At this point, we have two possible scenarios: the paper-based and the paperless ones

In a paper-based lab scenario, data can be printed in summary reports: by batch, by analysts, by instrument, …  The Instrument log book can be automatically generated too.

In a paperless lab scenario, as suggested by the name “middleware” the measurements can be transferred to a LIMS (Laboratory Information Management System), or an ELN (Electronic Laboratory Notebook) making the management of these measures completely paperless. In this scenario, Ioi can also act as a Smart Gateway by providing a single point of interface to several instruments by taking care of the communication to different instruments of different suppliers (the only requirements for the measuring instruments is the possibility to interface to a printer).

Over 5 instruments, it may be convenient to go for the implementation of an Ioi middleware

Other advantages of this software, whether it is connected to a LIMS or not, is that it reduces administrative tasks. In fact, they have centralized access management, which can be associated with company network security. And, as anticipated, it does not require date and time synchronization, since it is automatically synchronized with the company network.

In conclusion, as a rough estimation, if the number of simple instruments to be put in compliance is lower than 5, their compliance by procedural management is sustainable, over 5 it may be convenient the implementation of the Ioi middleware.

The post How to comply Data Integrity with simple instruments appeared first on .

[Free Webinar: Wednesday, November 21th 2018 – 15:30 CET ] 

So many topics under one single line!

Mark Newton is your expert to listen to when comes to understand compliance at the laboratory

Presenting: Mark Newton, principal at Heartland QA 

Mr. Newton is an independent consultant with 30+ years of experience in pharmaceuticals as a laboratory scientist, then as a QA professional, supporting LIMS systems, standalone lab instruments, lab informatics and metrics, validation, quality systems, and data standards.  Mark has been deeply involved in data integrity audits and data integrity training to people in QC Laboratories, Manufacturing, and IT.

Mark is also an important contributor at the International Society for Pharmaceutical Engineering.

• Current Chair of the ISPE Global Documents Committee
• Current co-leader of the ISPE/GAMP Data Integrity Special Interest Group
• Co-author for “GAMP Guide: Records and Data Integrity” April 2017
• Co-author of “Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification”  Schuessler, Newton, Smith, Burgess, McDowall. Pharm. Engineering, Jan/Feb 2014
• Co-editor of the GAMP Good Practice Guide “A Risk-Based Approach to Compliant Computerized Laboratory Systems” Nov. 2012

Outline of the first one-hour webinar course in which Mark will introduce the topics to be developed further in future sessions.

An interesting approach, challenging questions, solid conclusions from a 30 years experienced and well-known expert.

Context of the Instrument Qualification Activity

• Is it Validation, Qualification or Verification?

  • ASTM E2500 definition
  • News flash: Regulators don’t care!

• Benefits of doing the exercise, even for non-regulated labs

  • Question: if I could give a value +/- 25%, is that good enough?
  • Question: if the result might have calculation errors, is that acceptable?
  • Question: is it acceptable to let everyone in the lab change method calculations or configuration without telling anyone?
  • Question: more efficient to design technical controls or do more procedural (human) controls for every test?

The Lab results have a real Direct Impact on product quality! It’s really about Data, not Equipment: Data Lifecycle vs Equipment Lifecycle. Data integrity is not just for GMP activities

• Three questions to answer:
  • What activities will we perform?
  • How extensive does the activity need to be (robust)?
  • How thoroughly do we need to document the activity?
    • Example: Research vs QC Lab

Crafting an Organizational Approach to Analytical Equipment

• Holistic Approach (vs Qualify Equipment/Validate Software)
• Spectrum: USP <1058> and GAMP Lab Guide
• Putting it together: A Continuum of Activities
  • Criteria for the continuum:
    • Data Complexity (overall)
    • Factor: Vendor Dependence
    • Factor: Configurability
    • Factor: Electronic Records; Electronic Signature

Verification Activities and Deliverables

• Using the Continuum to Create a Grid of Activities
• Verification Planning (keep it simple!)
• Requirements: Critical step to get it right
  • Security/network/firewall
  • Access controls by design: some considerations
  • Factors to consider in the requirements phase
    • Access roles/duties (segregation)
    • Data integrity (identify records that need audit trails)
    • Traditional considerations: data inputs, calculations, reports, interfaces, environment
    • Leveling Requirements: User and functional, or one set?
    • Critical requirements (regulatory expectation)
      • Approach to managing requirements for future upgrades
    • Traceability
      • A powerful demonstration of control
    • Design Qualification (joining DQ with Requirements in a Simple Way)
    • Configuration
      • What most do wrong/why the configuration is a challenge
      • Value-added configuration documentation
    • Testing
      • Changes to accommodate holistic approach (IQ/OQ/PQ vs Unit/Integration/System)
    • System Acceptance
      • Normal Process
      • Managing Exceptions (or, how to avoid regulatory entanglements)
    • Operational Phase vs Development Phase

Vendor Management/Selection

• Often neglected, but Important to Success
  • Irrelevant terms, based on experiences: ISO, Market Leader, Long Relationship….
• Involving the Right People (who is needed, and why)
• Multiple Goals: vendor capabilities, data integrity gaps in product
• A wasted exercise when:
  • Does not lead to changes in our validation approach
  • Done too late/after the product is purchased (no influence on price!)

Efficiency in Verification Activities

• Designing Verification for Re-Use/Replication
  • Design protocols for re-use!
  • 90% re-use is better than 0% (Perfect is the enemy of Good)
  • Discuss: a process for multiple configurations
  • Discuss: a process for R&D/Development/GxP use

Mark´s webinar is part of the Academy Webinars Program, an initiative launched by the Paperless Lab Academy to maintain the momentum of the Congress acknowledged as a learning platform.

The post Qualification of Analytical Systems for Regulated Laboratories appeared first on .