PCS DMS — About

PCS DMS

Document Management System — System Information

Compliance · Login

Application

Version	1.0
Deploy URL	`https://192.168.0.137`
PHP Version	8.2.31
Database	MySQL 8.0.46-0ubuntu0.24.04.3
Last Validated	2026-05-20

Compliance

Active Documents

251

E-Signatures

3,532

Audit Rows

Regulatory Frameworks

21 CFR Part 11

FDA Electronic Records and Electronic Signatures. Full controls: consent, audit trail, sequence enforcement, authority checks, periodic password change.

EU GMP Annex 11

Computerised Systems. Validation, audit trail, data integrity, access controls, backup procedures.

GAMP 5

Software Category 4 (configured product). Risk-based validation approach with IQ/OQ/PQ documentation.

Documentation

21 CFR Part 11 Compliance Statement — full evidence table per subsection
Validation Pack: docs/validation/ — FS, Risk Assessment, IQ, OQ, Validation Summary
Audit Log — append-only sync queue (login required)