Electronic Quality Management
The quality system that is the procedure.
QStack gives a small or startup pharma company a GxP-defensible quality system on day one — no implementation project, no consultant package. Each process is implemented one way, the best-practice way, so the system itself acts as the SOP.
- 9
- quality modules, ready to run
- 1
- tamper-evident signing log
- 2
- data regions — US & EU
- 0
- per-customer GxP configuration
The modules
Quality Documents
Controlled SOPs, work instructions and policies with a governed lifecycle.
Quality Records
Form records and external uploads, full-text searchable, OCR included.
Training
A live matrix, auto-assignment on document effectivity, server-attested reads.
Deviations & CAPA
One flow: deviation → root cause → CAPA → effectiveness check.
Change Control
Impact assessment that spawns the revisions and training it implies.
Complaints
Intake, triage and closure, with complainant identity separable for GDPR.
Vendors & Audits
Qualification, the audit lifecycle, and a signed Vendor Summary Report.
Reporting
Live quality metrics and the Annex 11 §9 audit-trail review.
Onboarding
Import paper or a prior eQMS through a signed, dry-run reviewed batch.
Built to survive an inspection
Every electronic signature captures its meaning and the authentication used at the moment of signing. The audit trail is a hash-chained, append-only ledger — a retroactive edit breaks the chain, and each periodic export anchors it in your own archive.
21 CFR Part 11 · EU Annex 11 · ISO 9001 · GDPR