ISO 22716 software with the PIF live off your batch records — all 17 chapters, one QMS spine.
Cosmetics GMP for EU Responsible Persons, contract manufacturers, and brand owners preparing for the MoCRA GMP rule. All 17 ISO 22716 chapters mapped into one running QMS, a Product Information File reconstructable from live records, operator training linked to batch sign-off, and OOS investigations that survive the 2026 audit bar.
You're shopping because the certification body flagged 'shallow' compliance across half the chapters.
PIF is a static PDF that no longer matches manufacturing reality
OOS investigations default to 'lab error, retest, OK' — won't survive 2026 audits
Operator training lives in HR and isn't visible at batch release
Internal audits cover 4 chapters well and 13 shallowly
Recall test takes days because records live across 5 spreadsheets
Change control over premises, equipment and formula runs in email threads
ISO 22716, run as one system.
17-chapter chapter map
Every ISO 22716 chapter — Personnel through Documentation — mapped to live records. The pre-audit gap list writes itself.
Live Product Information File
PIF composed on demand from formula, MBR, finished-product spec, stability and safety assessment. RP and inspector see the same source.
Training linked to batch sign-off
Every batch step records who performed it and that their training was in date. 'Show me the training for this step on this date' is one query.
OOS with documented logic
Investigation flow that considers lab, sampling and manufacturing root causes with disposition logic — the shortcut path is structurally blocked.
Internal audit across all chapters
Scheduled audits per chapter, findings tracked to closure, evidence linked. No chapter goes 18 months without review.
Change control end-to-end
Premises, equipment, raw materials, packaging, process, method and personnel-responsibility changes in one register with impact assessment.
What changes the day this goes live.
- The RP-facing PIF and the ISO 22716 records are the same single source
- OOS investigations pass 2026 audit scrutiny without rebuild
- Recall test recovers every unit of a batch in hours, not days
- 60-day readiness path closes in 25–35 days for pre-configured cosmetics profile
- MoCRA GMP rule prep starts from a credible ISO 22716 baseline, not zero
The frameworks a cosmetics RP owns.
ISO 22716:2007
All 17 chapters modeled — Personnel, Premises, Equipment, Raw materials, Production, Finished products, QC lab, OOS, Wastes, Subcontracting, Deviations, Complaints & recalls, Change control, Internal audit, Documentation.
EU Regulation 1223/2009
Responsible Person workflow, CPNP notification data support, and Article 8 GMP compliance via ISO 22716 — same records, one source.
MoCRA (US)
Facility registration and product listing today; GMP-rule readiness on the ISO 22716 baseline FDA has signalled it will draw from.
ISO 9001:2015
Document control (7.5), competence (7.2), nonconformity & CAPA (10.2), internal audit (9.2), management review (9.3) — all modeled, all evidenced.
ISO 13485:2016
Design controls, DHF/DHR/DMR, risk management hooks (14971), CAPA, post-market — same engine, device-grade controls.
FDA QMSR (2026)
Aligned with the harmonized QSR/ISO 13485 final rule effective Feb 2026. Your QMS doesn't have to be re-architected — V5 is already there.
ISO 22716 software, answered.
Is ISO 22716 certification mandatory in the EU?
Compliance with the principles of ISO 22716 is required by Article 8 of Regulation 1223/2009; the certificate is not mandatory but is the most common demonstration to brand-owner customers and competent authorities.
How does V5 handle the Product Information File?
The PIF is a live composite drawn from the formula, MBR, finished-product spec, stability data and safety assessment. The RP works from the same records the inspector walks — no parallel PDF PIF to keep in sync.
Does this cover MoCRA?
V5 supports MoCRA facility registration and product listing today, and the ISO 22716 baseline positions you well for the pending MoCRA GMP rule, which FDA has signalled will draw heavily on ISO 22716.
How long to implementation?
Most cosmetics manufacturers close the 60-day ISO 22716 readiness path in 25–35 days because the chapter map, batch templates, OOS workflow and PIF composite ship pre-configured.
Turn shallow ISO 22716 into a defensible programme.
Free trial. Real PIF, real chapter map, real OOS workflow.