The Data Review in the Pharma Industry Laboratories
[Recorded on October 2021]
The Paperless Lab Academy® is glad to propose under the Academy Webinar Program umbrella, a presentation from Inpharmatic about the benefits of a paperless scenario for raw data, with or without a LIMS.
Pier Luigi Agazzi, Partner and Computer Validation Consultant at Adeodata
Graduated in Electronic Engineer (Master) in 1985, he attended some courses about AI at MIT in Boston and also a Master in Business Administration (MBA) at Politecnico di Milano.
From 1985 to 2000, he worked as an automation and process instrumentation engineer for chemical and pharmaceutical plants in international environments.
Since 2000, he is a Computerized System Validation Engineer and partner of Adeodata.
He took part in several 21 CFR Part 11 compliance assessment and gaps remediation plans for production and QC departments, working with ERP (SAP) and Electronic Batch Record Systems. He is also involved in several Data Integrity assessments.
He is an expert trainer and auditor specialized in computerized systems validation and Data Integrity compliance.
Since 1992, he’s an active member of GAMP Italia group and ISPE.
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.
- Consistency between data on the notebook/analytical worksheet and analytical request/order
- Validity of used reagents or accessories
- Availability of Raw data
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 will 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.
During this webinar we will talk about:
- The Data Review as an essential part of the data life cycle
- What to check during the Data Review
- Paper-based Data Review vs. Electronic Data Review
- How to improve effectiveness and the efficiency
- Exception Reports
WHO SHOULD ATTEND
- Quality Control laboratories of pharmaceutical industries
One hour free Online presentation includes Q&A session with the presenter/s
Access to the recorded session for the registrees
Inpharmatic, the R&D department of Adeodata, 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 develop solutions able to add the benefits of efficiency and integration to the pharma industry systems, making them compliant with Data Integrity requirements.
Inpharmatic is enlarging and structuring its organization in order to support the success of the proposed solutions.