Data Integrity: an Industry Initiative, a Local Approach
by Paul Walters, Group Leader, Validation and Data Integrity Department
Our industry is currently wrestling with the implications of recently published data integrity draft guidance documents provided by the FDA, WHO, MHRA and others. This has become an industry initiative and the lion’s share of the “c” in cGMP. The new buzzword in our industry is “Data Integrity.” This is clearly evidenced by many of our clients now conducting specific “Data Integrity” based audits of Eurofins, in lieu of or in addition to the traditional GMP audit we continue to experience frequently.
Although the ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) principles and expectations for data have long been part of our understanding of the original 21CFR Part 11 expectations for data, the bar has been raised higher with the expectation that the collective industry limit employees abilities to modify, change, delete or otherwise adulterate data through technical means rather than procedural controls or limitations. Furthermore, worldwide agencies are expecting a much more rigorous review of audit trails, data disposition and data lifecycle. They are also very clear in requiring the employment of a risk-based approach to assess current data systems and implementation of technical, rather than procedural controls for remediation whenever possible.
Our Local Approach
As we all are aware, training, and documentation thereof, has long been a GxP expectation found in all facets of our industry. Therefore, it should be no surprise that Ethics and Data Integrity training should be a paramount first step in ensuring our clients that their data is secure and integral at all times. Eurofins data integrity training of new employees begins at the first step. As part of our initial onboard regimen, specific training in Ethics and Data Integrity is included as part of each new employee’s acclimation to the Eurofins culture. Additionally, the ALCOA principles are “refreshed” in the minds of our employees through ongoing, required, periodic GMP training. In this way, we ensure from the onset (and routinely thereafter) that the expectation of Eurofins employees, is to maintain the integrity of the data we generate for our clients.
The life cycle of validation for a given process, equipment, instrument, or software begins with the documented plan for validation. An integral first step of this plan is understanding and documenting the functional requirements for the system. At Eurofins, we have introduced new processes and controls for the initial validation of software systems associated with our analytical systems. In this way, we are able to assess the overall strengths and weaknesses of the software packages provided by vendors. This begins with our validation team working with our vendors to understand the software capabilities and configurability in the areas of audit trail, data storage, data recovery, system security to name a few.
Our Data Integrity team is also currently reviewing our existing legacy systems. Currently, we have over 85 different analytical data acquisition software systems. Each of these systems may have multiple different instances installed on several PCs. We have employed a risk-based approach to reviewing these systems against Annex 11, 21CFR Part 11 and the aforementioned draft guidances. This review of each individual system determines the need for remediation to ensure our adherence to the ALCOA principles. This risk-based approach, combined with specific system-by-system unique remediation ensures our technical controls applied to these data systems are efficient and effective. Because of this, our clients can be sure we are at the forefront of this current and important industry initiative. They can also rest assured we can handle the data integrity issues and resolutions for just about any analytical data system they may have or require us to use for their analyses.
The field of Data Integrity is a moving target right now. The landscape is changing daily based upon increased understanding of data systems, data storage, and data life cycle throughout our industry. At Eurofins Lancaster Laboratories, we have always been dedicated to be at the forefront of new industry initiatives in the area of analytical testing. The industry initiative of Data Integrity is no exception for us today. Therefore, our clients can trust us to continue to be the leader in analytical data integrity concerns, issues, and resolutions for our industry. The ALCOA principles will continue to apply here, as they always have.