For pharmaceutical, biotech, clinical and testing laboratories
When an inspector questions your data, show each result exactly as it was recorded.
Data integrity findings are among the most common in inspections. The question is always the same: is this result the one the instrument produced, and was nothing changed or deleted since?
- When it is tested
- A GMP inspection; the review of a regulatory submission; a batch release dispute; an internal data-integrity investigation.
- What you will be asked for
- For computerised systems used in GMP, consideration, based on a risk assessment, of a system-generated audit trail recording all GMP-relevant changes and deletions (EU GMP, Annex 11, section 9).
- What goes wrong today
- Audit trails live inside the same systems and are configured by their administrators; exports are files anyone can edit; and an audit trail is still the system’s own word.
- What changes
- Each result, batch record or export is sealed when it is created. It does not replace your audit trail; it makes it checkable from outside, because any later change to a sealed file shows. The data stays in your systems.
Sealing shows that a record existed unchanged from a given moment; whether your records are enough is yours to judge. A seal is evidence beside your validated systems, not a validated system; whether and how it fits your quality system is your quality unit’s decision.
Try it in two minutes
- Choose a real file of your own: a result export or a batch record. It is read in your browser and never uploaded.
- Seal it on Seal a file. A free sandbox key is issued on the page; only a salted fingerprint reaches the log.
- Make a copy, change one character in it, and check both against the receipt at Check. The copy fails; the original passes.
From your own systems it is one API call per record. Integrate · Other industries