Electronic archiving is one of the most common weak points in GMP systems. Documents are scattered across paper archives, network drives, and multiple systems. When faced with the pressure of an inspection, it becomes clear whether information is truly available quickly, completely, and in a way that is audit-proof.
Common challenges in GMP archiving.
In practice, GMP-related documents are often scattered across various systems: paper archives, network drives, and legacy systems. During an inspection, it becomes clear whether documents are complete, traceable, and available within a very short time.
Typical risks:
Fragmented archival landscapes lacking a clear structure
Delayed document retrieval during inspections
Inadequate or missing Annex 11 validation
Weaknesses in data integrity and audit trails
Lack of governance for archiving and lifecycle management
These issues are among the most common causes of non-compliance during FDA and EU GMP inspections.
Regulatory requirements for electronic archiving systems.
Regulatory requirements such as EU GMP Annex 11 and 21 CFR Part 11, as well as rising expectations regarding data integrity, make it clear that archiving systems must not only be in place, but also structured, validated, and secured for the long term.
Organizations face the challenge of correctly interpreting regulatory requirements while integrating them into existing system landscapes.
How well prepared is your archive, really?
With our eArchive Readiness Check, you’ll receive an initial risk assessment and specific recommendations for improvement in just a few minutes.
Support for GMP archiving and Annex 11 compliance.
Entourage helps pharmaceutical, biotech, and medical device companies develop a structured archiving strategy, validate systems in accordance with Annex 11, and prepare effectively for inspections.
From gap analysis to computerized system validation and inspection simulation, we address the critical areas of your organization directly.
If you’re not currently sure whether your records would stand up to an audit, now is the right time for a structured assessment.
Ready to tackle your challenges?
We provide you with full support.