Commissioning & Qualification Platform

Commissioning & Qualification, audit-ready by design.

From URS to PQ — every requirement, test and signature connected in one fully digital platform.

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Free plan for teams of up to 5 users — no credit card required.

21 CFR Part 11GAMP 5GxP ReadyEU Annex 11
The Challenge

The problem in today's C&Q projects

Disconnected tools

Loop checks live in disconnected spreadsheets with no single source of truth.

Weak traceability

URS to FS/DS mapping and protocol evidence are still assembled manually.

Execution delayed

Teams spend too much time preparing IQ/OQ/PQ paperwork instead of running tests.

What You Can Do

Every document of the V-model, in one place

You write the specifications on the left and prove them with tests on the right. MGTrace keeps every line linked across the V, so the traceability matrix, the signatures and the audit trail are already there when the auditor asks.

  1. URS

    User requirements

    What the system must do: one requirement per line, each with a tag that can be followed from then on.

    PQ

    Performance qualification

    Proves the system performs for its intended use, requirement by requirement.

  2. FS

    Functional specification

    How it does it: functions, sequences, alarms and interlocks, each traced to the requirement it answers.

    OQ

    Operational qualification

    Tests every function against the FS, with acceptance criteria that can actually fail.

  3. DS

    Design specification

    Hardware, software, instruments and configuration, traced to the FS.

    IQ

    Installation qualification

    Checks what was installed against the DS: model, version, wiring.

  4. I/O list

    Signals

    Every signal with its tag, type, signal and engineering ranges and fail-safe state, traced to its design element.

    Loop check

    Signal tests

    One test per signal, generated from the I/O list and executed in the field from a tablet.

FAT · SAT

Commissioning

Factory and site acceptance tests, pre-commissioning and functional testing, executed here and kept as evidence the qualification can lean on.

And around the V

  • Traceability matrix

    Writes itself from the links, level by level, and exports to CSV for the audit.

  • Discrepancies and punch list

    Raised from a failed step, tracked to closure, never lost in an e-mail.

  • Electronic signatures

    Review and approval of every document and execution, designed for 21 CFR Part 11 and Annex 11.

  • Audit trail

    Who changed what, when and why, on every record, stamped by the database clock.

  • Controlled copies

    PDF and Word exports with the signature manifest, for clients and inspectors.

  • Your own documents

    Risk assessments, custom documents and templates, placed on the rung of the V you choose.

Who It's For

Built for every role on the project

MGTrace maps to how commissioning and qualification teams actually work - not how software vendors think they do.

Industrial control and PLC hardware

AUTOMATION ENGINEER

The person who knows every I/O on the panel.

  • →Define I/O in the FS and generate loop checks automatically
  • →Execute DI/DO/AI/AO/NI/VI tests from tablet in the field
  • →Export test results directly to IQ documentation
Process control and SCADA monitoring

C&Q ENGINEER

Responsible for the qualification strategy and execution.

  • →Structure the V-Model from URS through IQ/OQ/PQ
  • →Track traceability gaps before the auditor does
  • →Generate protocol documents from approved specifications
Pharmaceutical production environment

Validation Engineer /
CSV Specialist

Signs off that everything was done right.

  • →Review the audit trail and electronic signatures
  • →Approve documents with e-signatures designed for 21 CFR Part 11
  • →Export controlled PDF/Word copies with the signature manifest
Everything You Need

Everything your team needs

  • Traceability map

    Connect URS, FS, DS, IQ, OQ, and PQ evidence in one flow.

  • Loop testing

    Execute DI, DO, AI, AO, NI, and VI checks with structured records.

  • Auto protocols

    Generate protocol documents from approved specifications.

  • Audit trail

    Track all actions with timestamps and signature-ready records.

  • Field-ready UX

    Use responsive screens in site and commissioning environments.

  • Report exports

    Create consistent qualification reports for client handover.

MGTrace dashboard in use
Audit-Ready by Design

Built on the standards your QA team already uses

We did not add compliance as an afterthought. MGTrace is structured around GxP principles from the ground up.

Electronic Signatures

Sign-off records designed for 21 CFR Part 11: password re-verification, printed manifestation and role-based approval workflows.

21 CFR Part 11

Audit Trail Integrity

Maintain a complete history of who changed what, when, and why across project documents.

GAMP 5

Traceability Coverage

Link URS, FS, DS, and test evidence so qualification gaps are visible before review.

GxP

Validation Reporting

Export structured reports and supporting records for submission and internal QA approval.

EU Annex 11

Start qualifying smarter today.

Free plan for teams of up to 5 users — create your organization in minutes, with projects, protocols and full traceability from day one.

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