Compliance & Data Integrity
Schedule M, 21 CFR Part 11, EU GMP Annex 11 and ALCOA+
Compliance is not a feature list. It is whether the system's records survive contact with an inspector. DeepPharmaERP is designed around the audit trail and the electronic signature first, and everything else is built on top of them.
What is built in
Schedule M (revised)
Documentation flow, record retention and the quality system elements the revised schedule requires.
21 CFR Part 11
Electronic signatures with meaning and intent, re-authentication at signing, and a tamper-evident audit trail.
EU GMP Annex 11
Computerised system controls, risk management, data storage and periodic evaluation.
ALCOA+
Attributable, legible, contemporaneous, original, accurate — plus complete, consistent, enduring and available.
WHO GMP and PIC/S
Documentation and control expectations for exporters to regulated markets.
How we hold ourselves to it
The audit trail is append-only
Written to a separate store, not deletable by any role including system administrator, with server-side timestamps so a workstation clock cannot back-date an entry.
Reason for change is mandatory
The trail records what changed, who changed it, when, and why. Without the why it is a log, not an audit trail.
Signatures mean something
Performed by, verified by, approved by — each distinct, each re-authenticated, each bound to the exact version of the record signed.
No shared logins, ever
The system is built so that shared accounts are not a workaround anyone needs.
Validation is a deliverable
IQ, OQ and PQ protocols, a traceability matrix and the executed evidence are handed over with the build, not sold afterwards.
See it on your own floor.
Two hours with your production and QA leads. We walk one product end to end and show you where it lands in the system — then you decide whether a gap study is worth it.