Lab Data Integrity and Data Quality - Part 2

These two courses have the following objectives:

Part 1:
The learning objectives are firstly, understand the data integrity requirements of a GMP regulated laboratory in Pharmaceutical organisations and contract labs from sampling to reporting.  Secondly, how laboratory personnel can ensure compliance and be able to defend their positions. Records generated by three processes will be taken through the presentations and workshops: paper only with records maintained in a laboratory notebook or controlled sheets, hybrid system with signed paper records with underlying electronic records and an electronic system using electronic signatures. Second person review is a critical process that needs to be thorough and effective to ensure that data issues are picked up and resolved.

Part 2:
The auditing course will develop the understanding of what is required for a data integrity audit of a laboratory computerized system and then develop the principles, based mainly on workshops and discussions, of how to audit hybrid and electronic laboratory systems. The scope of auditing a system for data integrity will be developed during the course along with a risk based prioritisation of the key areas to focus audit attention on. In preparation for the final sessions there will be workshops dealing with specific data integrity topics. At the end, attendees will read the laboratory audit report, determine if there are any findings and classify them. Then feedback selected audit findings to the Quality Control manager and head of Quality Assurance.

A checklist will be provided to all attendees for the auditing of computerised systems for data Integrity.

Data Integrity continues to be the major concern with both FDA and European Regulatory Agencies. Many FDA warning letters and EU GMP inspections have highlighted major data integrity failures at companies globally. The regulatory concern has been responded by FDA issuing three versions of Compliance Program Guide (CPG) 7346.832 that covers Pre-Approval Inspections in 2010, 2019 and 2022. The latest version extends the objectives to include Quality in Pharmaceutical Development. Since 2015, various regulatory authorities have published data integrity guidance documents e.g.

Moreover, EU GMP Annex 11 for computerised systems and Chapter 4 on documentation are being updated to enhance the requirements for data Integrity. Industry bodies have also been active with the GAMP Forum publishing a Records and Data Integrity Guide in 2017 and three Good Practice Guides.  APIC and PDA have issued guidance documents on the subject.

Finally, ECA have issued the 3rd Edition of a Data Governance and Data Integrity Guide that delegates will get a free electronic copy of.

The emphasis of all regulators is on the ALCOA++ principles to outline regulatory expectations for ways to ensure the integrity of data over the life cycle. This is reflected in the way the two courses will be presented.

Part 1 focuses on three types of record that can be found in analytical laboratories working to GMP: paper, hybrid computerized system and electronic workflows with electronic signatures. Through presentations, work- shops and discussions attendees are taken through the process from sampling to generation of the reportable value to understand data integrity issues.

Part 2 takes the principles from the earlier course and develops them to enable attendees to be able to conduct effective internal audits or self-inspections of either hybrid or electronic systems in compliance with EU GMP Chapter 9. This is achieved mainly via a series of interlinked workshops with a few presentations.