Lab Data Integrity - Meeting FDA & EU Concerns - Part 1
Im Auftrag der ECA Academy

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 and 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 feed back 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 is currently the major concern with both the 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 the FDA issuing Compliance Program Guide (CPG) 7346.832 that covers Pre-Approval Inspections. This document became effective in May 2012 after Agency inspectors received training in Data Integrity where they focus on computer systems and not the paper output. The CPG objective 3 covers the laboratory data integrity audit. In April 2016 a draft Data Integrity guidance was issued for industry comment.

In March 2015, also MHRA issued an updated Data Integrity Guidance containing an expansion of the expectations of Data Integrity governance together with a list of 19 definitions and expectations for each one. Followed in July 2016 by a more general guidance for GXP data integrity.

In June 2016, the World Health Organisation issued a final version of a guidance document which provides a more encompassing explanation of Data Integrity and also data governance expectations for regulated healthcare companies. EMA and PIC/S both issued draft Data Integrity guidance documents in August 2016. ECA have published two versions of Data Governance and Data Integrity guidance in 2016 and 2018. The GAMP Forum has  published a Guide on Records and Data Integrity in 2017 and the first of three Good Practice Guides on Data Integrity - Key Concepts. Lastly, PDA has also issued a guidance document for pharmaceutical laboratories in August 2018.

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 analysis to generation of results to under- stand 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. This course will focus only on hybrid and electronic Systems.