How do manufacturers plan and execute verification and validation in compliance with standards, without the evidence falling apart in an audit?
We support the complete V&V chain from design verification and validation through to process validation with Installation, Operational and Performance Qualification (IQ, OQ, PQ), planned in line with ISO 13485:2016 and the process validation requirements of GMP. The decisive weak point is rarely the individual test, but traceability: when every test case does not point unambiguously to a design input or a process specification, the notified body or the inspector reviews not the product, but the gap in your traceability.
- Pharma
- Biotech
- MedTech
- IVD
Overview
What requirements do V&V place on manufacturers in MedTech and pharma?
Design V&V and process validation across pharma, biotech, MedTech & IVD · ISO 13485:2016, GMP (IQ/OQ/PQ), 21 CFR Part 820
Last updated: 2026-06-13
Verification and validation are not a final test campaign, but a continuous body of evidence: verification demonstrates that the product or process meets the defined requirements; validation demonstrates that the intended use is achieved under real-world conditions. Four points determine whether this evidence holds up in an audit:
- The V&V plan does not cover all regulatory requirements because it is created too late. Under ISO 13485:2016, and additionally under EU 2017/745 (MDR) for medical devices, the planning must define the scope, the acceptance criteria and the responsibilities before testing begins.
- Test protocols are not traceable to design inputs or product specifications. Without an end-to-end traceability matrix, it cannot be shown that every requirement has been verified and the intended use validated.
- Process validations with Installation, Operational and Performance Qualification (IQ, OQ, PQ) are incomplete or do not conform to Annex 15 of the EU GMP Guide, which governs the qualification and validation of processes.
- Revalidations following process changes, supplier changes or site relocation are forgotten or carried out indiscriminately, instead of being planned in a targeted manner based on an impact assessment.
Services
How we support you
V&V strategy & master plan
V&V master plan for product development or production with a defined scope, responsibilities, acceptance criteria and schedule. Deliverable: an approved master plan that maps the V&V activities to the regulatory requirements under ISO 13485:2016.
Design verification & validation
Preparation of design V&V plans and protocols as well as review and approval of the test reports. Deliverable: a traceability matrix that traces every test case back to a design input and product specification.
Learn more →Process validation (IQ, OQ, PQ)
Complete process validation packages for manufacturing processes with Installation, Operational and Performance Qualification per Annex 15. Deliverable: IQ, OQ and PQ protocols together with reports for processes such as sterilization, filling or welding.
Learn more →Revalidation strategy upon changes
Impact assessment for process changes, supplier changes or site relocation. Deliverable: a documented assessment with a targeted revalidation scope that covers the changed area, without indiscriminately revalidating intact processes.
Sterile process & cleanroom validation
Validation of critical sterile processes and cleanroom conditions in alignment with Annex 1 of the EU GMP Guide. Deliverable: validation protocols for processes whose output cannot be fully verified by end-of-line testing.
Learn more →Computer system validation as a V&V subdomain
Integration of CSV into V&V planning for computerized processes and test equipment. Deliverable: an aligned interface between process and system validation, so that the same requirement is neither covered twice nor missed entirely.
Learn more →How we work together
What it comes down to
Verification and validation rarely fail on the individual test, but on the sequence. The V&V plan must be in place before the first protocol is executed, because it derives the acceptance criteria from the design inputs and process requirements. Only then can a traceability matrix be built that traces every test case unambiguously back to a requirement. Anyone who reverses this sequence and tests first ends up with a matrix that is backfilled after the fact. It is precisely there, at the unsupported or duplicate links, that the review by the notified body under EU 2017/745 (MDR) or the inspection against GMP requirements takes hold.
The second bottleneck lies between verification and validation. Verification demonstrates that specifications are met; validation demonstrates the intended use under real-world conditions. For processes whose output cannot be fully verified by end-of-line testing, such as sterilization, filling and welding, Annex 15 of the EU GMP Guide requires process validation with IQ, OQ, PQ. With every subsequent change, an impact assessment determines the revalidation scope, so that the changed area is covered without indiscriminately revalidating intact processes.
Our approach
Our approach
Step
Result
V&V planning
Approved V&V master plan with scope, acceptance criteria and responsibilities, derived from design inputs and process requirements.
Build traceability
Traceability matrix that links every requirement to a specific test case before protocols are executed.
Execute verification & validation
Executed design V&V and process validation protocols (IQ, OQ, PQ) with documented results against the acceptance criteria.
Review & approval
Reviewed and approved V&V reports, deviations assessed and closed out.
Change control & revalidation
Impact assessment per change, targeted revalidation scope defined and executed.
Common pitfalls
Where projects commonly fail
The V&V plan is not created until development is nearly complete.
By then, design inputs and acceptance criteria can no longer be derived cleanly, and the test campaign measures against assumptions rather than against defined requirements. This is the most common reason why V&V evidence fails to hold up in an audit.
Traceability between test cases and design inputs is missing or constructed after the fact.
The notified body under EU 2017/745 (MDR) requires a seamless link between every requirement and its evidence; a matrix backfilled in hindsight is exposed by unsupported or duplicate links.
Process validation is reduced to end-of-line testing.
For processes such as sterilization, filling or welding, whose output cannot be fully verified, Annex 15 of the EU GMP Guide requires validation with IQ, OQ, PQ. A passed final test does not replace it.
Verification and validation are treated as equivalent.
If you only verify that specifications are met, you lack the evidence that the product fulfills its intended use under real-world conditions. This is precisely the validation step required under ISO 13485:2016.
Revalidations are forgotten or rolled out indiscriminately across the entire production.
Without an impact assessment, either a relevant change goes unrevalidated, or unnecessary effort is incurred for processes that are not affected by the change at all.
FAQ
Frequently asked questions
Sources
- ISO 13485:2016: Quality management systems for medical devices
- EU GMP Guide Annex 15: Qualification and Validation
- Regulation (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR): primary text
- 21 CFR Part 820: FDA Quality Management System Regulation (QMSR)
- Writer source material: verification-and-validation.md (Research & Development)
- https://theentourage.de/expertise/verification-and-validation/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- ISO 13485:2016 (QM system for medical devices)
- EU 2017/745 (MDR)
- EU 2017/746 (IVDR)
- 21 CFR Part 820 (FDA Quality Management System Regulation, QMSR)
- EU GMP Guide Annex 15 (Qualification and Validation)
- EU GMP Guide Annex 1 (Manufacture of Sterile Medicinal Products)
- ISO 14971 (Risk management for medical devices)
Related topics
Design Controls →
Design V&V as part of the design controls chain in product development
Process Validation →
IQ, OQ, PQ and revalidation of manufacturing processes in detail
Computer System Validation →
CSV as a specific V&V domain for computerized systems
Annex 1 (Sterile Manufacturing) →
Validation of sterile processes per Annex 1 of the EU GMP Guide
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