Summary of APIC’s FAQ document on Data Integrity

April 27, 2023

In April 2023, APIC (the Active Pharmaceutical Ingredients Committee) published the document “Data Integrity Frequently Asked Questions (FAQ)” on their website. The document contains a collection of questions from the industry and the corresponding answers from the DI task force subject matter experts.

A total of 13 questions were divided into 5 main categories:

Digital and electronic signatures
Password management
Access management
Record life cycle management
Various

Here is an overview of the questions that are of highest interest to the pharmaceutical industry:

Digital and electronic signatures:

The FAQ document discusses what differentiates e-signatures from digital signatures, how to best handle digital signatures in an electronic document system and scanning paper-based signatures on GxP documents. Hybrid signatures (electronic signatures that are notarized) were also discussed and should generally be avoided.

Password management:

The APIC informs about requesting passwords in a data recording. Another topic was the storage of passwords in the Internet browser for the GxP applications with the recommendation to disable the storage of passwords in the browsers.

Access management:

The FAQ explains what the DI-Taskforce recommends for third-party accounts and points out that personal accounts should also be used in these scenarios.

Record life cycle management:

APIC provides guidance on how to protect important paper records and whether paper archives can be destroyed after digitization. It also discusses how to handle data when software or hardware needed to view or analyze data is no longer supported.

Various:

The pharmaceutical industry is also interested in how visual data (e.g., color changes) should be noted in an experiment and whether personal notes are prohibited in a GxP environment.

The FAQ document is related to the existing April 2022 APIC General Guideline [1] and is a living document of the DI task force that will be expanded as more questions are sent in. The document is an effective guide to help with data integrity and shows a great way to get your own data integrity questions answered by subject matter experts.

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[1] Practical risk-based guide for managing Data Integrity – Revision 2, April 2022 from APIC (ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE).