34th SQA Annual Meeting and Quality College

W-1  Electronic Data Integrity – Take Action Now

Abstract:
Part 11, Annex 11, and similar regulations have been in place for years to ensure electronic data integrity.  However, the FDA, EMA, MHRA, WHO, and PIC/S have all seen the need to publish additional documents in the last few years to address widespread data integrity issues.
By now many IT and Quality Assurance professionals at GMP, GCP, and GLP compliant organizations are familiar with the acronym ALCOA and know that the ALCOA principles are the keys to data integrity.  They might even be participating in Data Integrity compliance assessments, much like the Part 11 compliance assessments of a few decades ago.  But, what actions will be the outcome? And, can these actions start now?
The answer is ‘yes’.  Unlike the Part 11 compliance initiatives of the 1990s, many actions required to address data integrity vulnerabilities can be addressed without expensive computer system replacement programs.
This presentation will describe actions that organizations can take now to prevent or remediate electronic data integrity gaps in the following 10 critical areas:  security and user access, audit trails, back-ups, record storage, record copies, validation, issue investigation, out-sourced services, out-sourced systems, and training.
And, since much can be learned from FDA Warning Letters about what not to do, we will look at examples of sometimes common and sometimes surprising data-integrity compromising practices that have been cited in the last 2 years.

Category:
IT Compliance

Level of Content:
Intermediate

W-2  Do You Really Know What Records You Have? 

Abstract:
One of the primary objectives of a sound records management program is defensible disposition of unstructured electrconic content that has met retention requirements. The challenge often lies with clearly identifying and classifying the content that is, or needs to be, archived. In today's digital world, electronic content is far surpassing physical content which results in storage of records that are duplicative, obsolete, and/or not appropriately classified. This is particularly true following a merger or acquisition when you 'inherit' large volumes of unknown content that must be stored. Now knowing the true nature of the content results in long-term storage of records for far longer than may be required. However, a manual review of large collections of electronic content is not feasible. The goal of this presentation will be to provide a review of an Auto-Classification Proof-of-Concept project that we recently completed.

Category:
Scientific Archiving

Level of Content:
Intermediate