Commissioning and qualification software
From the I/O list and the first loop check to FAT, SAT and IQ/OQ/PQ, MGTrace keeps every commissioning and qualification protocol traced to the specification it verifies. One system, one V-model; one plant, one traceability matrix — with the loop checks generated from the I/O list into a protocol that is reviewed, executed and signed like everything else.
The first 5 users are free, with no time limit; every further user is €39 a month. Data hosted in the EU.
Integrated commissioning and qualification — ASTM E2500, ISPE Baseline Guide 5 — rests on one idea: verification done well once, at the right level, is not repeated. A loop checked and documented at commissioning is evidence for the IQ; a function proven at FAT and confirmed at SAT is leveraged in the OQ. That only works if the commissioning records are as controlled and as traceable as the qualification ones. In practice they rarely are: the loop checks sit in a contractor's spreadsheet, the FAT in a supplier's PDF, and the qualification team starts again.
MGTrace treats the I/O list, the loop checks and the commissioning protocols as first-class controlled records: authored under version control, traced element by element to the design, executed with results that stay put, signed. The V-model of each system shows both legs — specifications down, commissioning and qualification up — and where each protocol sits on it is yours to decide.
Signal and engineering ranges kept apart (4–20 mA for 0–5 bar), the columns your project needs — rack, slot, channel — and each signal a traceable element linked to the design element that specifies it. Reviewed and approved like the DS.
Test procedures per class (AI, AO, DI, DO…) instantiated for every signal with its own range and unit — a 4–20 mA loop checked at 0, 50 and 100 % of span — generated from the I/O list into the loop-check protocol, executed and signed there; every test traced to its signal.
Protocols authored as test cards in a document, reviewed, approved, released for execution — the same workflow as the qualification protocols, with punch items raised where something is left open.
Qualification protocols with steps, expected results and acceptance criteria; results, evidence and signatures recorded on the released version; discrepancies with their own lifecycle.
URS, FS, DS and the build on the left; loop checks, FAT, SAT, IQ, OQ, PQ on the right; the count of verification traces between each pair. Move any protocol to the rung your strategy puts it on.
Requirement → element → I/O → loop check → tests, read live per project or across the plant, gaps in amber, exported to CSV.
Open items from commissioning tracked to closure with owner and date; failed qualification tests raised as discrepancies and resolved before approval.
21 CFR Part 11 electronic signatures with meaning and reason, hashed into a GMP audit trail; two-factor authentication; 15-minute inactivity log-off.
Load a complete vial-filler example — URS to PQ, six signals, loop checks, FAT, SAT, IQ/OQ/PQ — into a test site and see the whole chain before you write a line.
Site, areas, systems. The V-model, the documents and the protocols hang off the system.
URS, FS, DS with tagged elements traced level by level; the I/O list with each signal traced to its design element.
Generate the loop checks from the I/O list into their protocol; execute them; run pre-commissioning, FAT and SAT from their protocols; raise punch items.
IQ against the design, OQ against the functions, PQ against the requirements — leveraging what commissioning already proved, and saying so in the trace.
The traceability matrix and the executed protocols are the evidence; the validation summary report reads from them.
No vendor names: what matters is the way of working. Most projects run commissioning in the contractor's spreadsheets and qualification in Word; the alternative usually offered is a qualification-only suite that leaves commissioning outside.
| Spreadsheets & Word | Generic document / QMS suite | MGTrace | |
|---|---|---|---|
| Loop checks | One spreadsheet per contractor; results typed in later. | Outside the tool. | Generated per signal from templates into a protocol, executed and signed, traced to the signal, part of the audit trail. |
| FAT / SAT | Supplier PDFs, filed; nothing traced. | Attached as documents; tests not traced to elements. | Protocols with test cards, each test traced to the functional element it verifies; SAT leverages FAT in the matrix. |
| Leverage into IQ/OQ | By argument in the summary report. | Manual cross-reference. | Visible in the V-model and the matrix: a design element verified at pre-commissioning and at IQ shows both. |
| Punch list | Another spreadsheet. | Sometimes. | Punch items on the protocol they came from, with owner and target date, closed before approval. |
| Time to first protocol | Immediate; every project from zero. | Weeks to months of configuration. | The same afternoon, from a template or the worked example. |
| Cost | Free, plus the hours. | Enterprise licence, quoted. | Free for the first 5 users; €39 per further user and month. |
The I/O list and every protocol are documents: draft, review, approval, release, and amendments once approved — never edits in place.
Design element → signal → loop check; functional element → FAT/SAT test → OQ test. Links are recorded, dated and attributable; the matrix recomputes from them.
Results are recorded on the released version, with evidence, and signed per execution; a loop check is a test of its protocol, recorded there, not retyped from a sheet.
Electronic signatures with meaning and reason, a GMP audit trail, two-factor authentication, inactivity log-off, EU hosting and a validation package for the platform itself.