GMP Change Control, reimagined

Every change, fully traceable — from request to closure.

Traceable CCMS is a compliant, configurable change-control platform for GMP environments: enforced workflows, electronic signatures, tamper-evident audit trails, and a complete validation package out of the box.

21 CFR Part 11EU GMP Annex 11 ALCOA+GAMP 5
The product

Everything GMP change control needs. Nothing it doesn't.

A focused alternative to heavyweight eQMS suites — faster to validate, easier to use, and built around your SOPs.

Template-driven workflows

Each change type follows a configurable stage template — the right person, at the right step, every time.

E-signatures & SoD

Attributable approvals with identity, time and meaning. Separation of Duties enforced automatically.

Tamper-evident audit trail

Append-only, hash-chained history of every transition, field change and security event.

Impact assessment

Committee-based IA across configurable domains with rules-driven Critical / Major / Minor classification.

Document control

Versioned attachments — superseded, never deleted — with required documents enforced per change type.

Retention & archival

Configurable retention periods, read-only archives, and periodic review of stale changes.

The lifecycle

One enforced path. Zero shortcuts.

The workflow engine guarantees order, authorization and data completeness at every transition.

1
Draft
2
Submitted
3
QA Review
4
Impact Assessment
5
Implementation
6
Verification
7
Closed
Compliance by design

Built for regulated environments.

Compliance isn't bolted on — it's the foundation of every record, signature and transition.

21 CFR Part 11

Electronic records & signatures with full attribution and control.

EU GMP Annex 11

Computerised-system controls: access, audit, change control, archival.

ALCOA+

Attributable, legible, contemporaneous, original, accurate — and complete.

GAMP 5

Risk-based validation with a full Category-5 documentation set.

Validation-ready

Ship with the paperwork already done.

Most vendors make you build the validation from scratch. Traceable CCMS arrives with the complete CSV package — your team executes, we support.

VMPURSFRSDS RARTMIQOQ PQVR
0automated tests passing
0validation documents included
0enforced workflow stages
0audit coverage of actions
Get in touch

Let's make your change control traceable.

Book a live demo, ask about pricing, or discuss a pilot — we reply within one business day.

Email
moazelessawey@gmail.com
Phone
+20 0155 4913 379
Headquarters
Egypt
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