In regulated manufacturing, a result is only as trustworthy as the record behind it. Data integrity — the assurance that data is complete, consistent, and attributable from the moment it is generated — is the foundation on which every release decision rests. When it is strong, inspections are straightforward. When it is weak, even good science becomes difficult to defend.
Why data integrity matters
Regulators worldwide have made data integrity a focal point of inspection. The reason is simple: if records can be altered, lost, or disconnected from their source, then no downstream conclusion can be fully trusted. For partners, a supplier’s data practices are not a back-office detail — they directly affect the defensibility of a filing.
The principles we build around
Our quality systems are designed around the widely recognized ALCOA+ expectations — that data should be attributable, legible, contemporaneous, original, and accurate, as well as complete, consistent, enduring, and available. In practice that means:
- Every record is attributable to a person and a time, with no gaps.
- Results are captured contemporaneously, not reconstructed after the fact.
- Original data is preserved and protected, with controlled, traceable changes.
- Records remain legible and retrievable throughout the required retention period.
A clean batch record is not paperwork after the science. It is part of the science.
Digital by design
Wherever possible, we capture data in validated electronic systems rather than transcribing it by hand. Automated capture reduces the opportunity for transcription error, preserves audit trails, and makes batch genealogy — the full lineage from starting material to release — reconstructable on demand.
Inspection-ready, always
The result is documentation that does not need to be prepared for an inspection because it is already in inspection-ready form. For our partners, that means fewer surprises, faster responses to regulator questions, and confidence that the data supporting their product will hold up to scrutiny.
Published by Global Biotech Laboratories. The information above is provided for general information and does not constitute regulatory, medical, or legal advice.