GxP change control · ICH Q10 · 21 CFR 211.100
Change control software that classifies, assesses and closes every GxP change with evidence.
In a regulated plant, every change to a process, spec, equipment, supplier, system or facility has to be classified, impact-assessed across quality, regulatory, validation, training and safety, implemented with actions that actually close, and verified for effectiveness before the change control shuts. V5 replaces the change-control form plus the impact-assessment spreadsheet plus the CAPA/validation/training tickets with one change-control file that carries the entire lifecycle.
Classified changes with defined pathways
Cross-Functional Impact Assessment
Regulatory Reportability Screen
Implementation Actions Linked to Validation, Training & Documentation
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping because change controls sit open for months, changes get implemented before assessment, and the effectiveness check is a signature nobody defends.
Change requests are a form in one tool, impact assessments in a second, actions in a third — nothing reconciles
Changes get implemented before the impact assessment is complete because production wants it now
Regulatory reportability (Type IA/IB/II, PAS/CBE-30/annual, 510(k) letter-to-file, MDR significant-change) is a judgement call nobody documents
Actions in CAPA, validation, training and documentation are opened separately and lose their link to the change
The effectiveness check is a signature at closure, not a defined criterion measured on real data
The change register can't answer 'what changes are open on this product / this line / this system?' in one query
Change control, run as one live file.
Classified changes with defined pathways
Every change is classified — planned / unplanned, major / moderate / minor, GxP / non-GxP, product / process / system / facility / supplier — with a defined pathway per class. Minor administrative changes don't need a full CCB; major process changes can't skip one.
Cross-Functional Impact Assessment
Structured impact assessment across quality, regulatory, validation, stability, product performance, safety/PV, supply chain, training, computer systems and safety. Each function signs its assessment; the change can't progress until every applicable function has signed.
Regulatory Reportability Screen
Built-in screens for FDA CBE-30/PAS/annual report, EMA Type IA/IB/II variations, MDR/IVDR significant change and 510(k) letter-to-file decision trees. The screen output is captured as evidence — the regulatory decision is defensible, not a hallway call.
Implementation Actions Linked to Validation, Training & Documentation
Actions open in the modules that own them — validation protocols, training assignments, document revisions, supplier requalification, spec updates — but stay linked to the parent change.
Effectiveness Check with Defined Criteria
Per ICH Q10, the effectiveness check is a defined criterion (yield, defect rate, deviation count, PM completion, in-process metric) measured against a defined window after implementation — with real data pulled from the batch record, not a subjective signature.
Live Change Register by Product, Line, System
Every open change is visible against the product, line, equipment, system or supplier it touches — so QA can answer 'what's changing on Product X right now?' in one query, and cumulative-change risk is tracked across the annual product review.
What changes the day this goes live.
- No change is implemented before its impact assessment is signed by the applicable functions
- Regulatory reportability is a documented screen, not a hallway call
- Validation, training and documentation actions stay linked to the parent change — nothing gets orphaned
- The effectiveness check is a measured criterion, not a signature
- The APR / PQR sees cumulative changes on the product without a manual pull
The frameworks a change owner has to satisfy.
ICH Q10 §3.2.3 · Q9(R1)
Pharmaceutical Quality System — change management enabler, with proposed changes evaluated, approved and implemented under quality risk management principles (ICH Q9(R1)).
21 CFR 211.100(a) · EU GMP Ch.1 & Annex 15
US cGMP written procedures for production and process control; EU GMP change control as part of Chapter 1 PQS, with Annex 15 §11 requiring change control to include validation impact.
ISO 13485 §7.3.9 · MDR Art.10 & Annex IX
Medical device design changes and QMS changes controlled; EU MDR significant-change assessment for CE-marked devices; 510(k) letter-to-file for US devices per 21 CFR 807.81(a)(3).
Change control software, answered.
How does V5 stop a change from being implemented before assessment?
Implementation actions — validation execution, SOP release, spec change, supplier switch — check the parent change's status. Emergency changes have a defined fast-track pathway with retrospective assessment obligations, still tracked in the same file.
How is regulatory reportability decided and evidenced?
The reportability screen runs the change through the applicable decision tree (FDA post-approval CBE-30 / PAS / annual per 21 CFR 314.70; EMA variation Type IA/IB/II per Reg 1234/2008; MDR/IVDR significant change per MDCG 2020-3 / 2022-6; 510(k) letter-to-file per FDA 2017 guidance). The answers are captured; the classification is signed by RA; the submission (or the file note justifying no submission) is linked to the change record.
How does V5 handle the effectiveness check?
At approval, the change owner defines the effectiveness criterion — a measurable metric (yield, in-spec rate, deviation count, in-process value, PM completion, complaint rate), a source (batch record, deviation log, complaint system, ERP), a review window (e.g. At the window close, V5 pulls the metric from the source system and the effectiveness check pass/fail is data-backed, not opinion.
How does change control connect to CAPA, validation and training?
Actions live in their native modules — CAPA opens in CAPA, protocols in validation, R&U assignments in training, spec updates in document control — but every action carries the parent change ID. Conversely, a CAPA that requires a process or spec change opens a change control as its implementation vehicle, so the two systems don't drift.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Run change control on one live GxP file.
Free trial. Real classification, real assessment, real actions, real effectiveness check.