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.

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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.

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