CSV · GAMP 5 · IQ/OQ
Validation lifecycle records for computerised systems.
Keep validation documents and traceability together.
IQ/OQ and Validation Support with Enterprise
Enterprise includes IQ/OQ and validation support; exact deliverables are set in your accepted quote/SoW.
Enterprise IQ/OQ and Validation Support
Enterprise includes IQ/OQ and validation support; exact deliverables are set in your accepted quote/SoW.
Periodic Review as Scheduled Work
Annual system review, account review, audit-trail review — all scheduled, signed, and tracked as first-class records.
What goes wrong today3 common problems
Validation Packs Cost More than the Software
Validation effort for computerised systems is often underestimated when buying software.
Traceability matrices are kept by hand
URS → FRS → test case → script → evidence — maintained in spreadsheets, broken on every change, redone before every inspection.
Periodic review is improvised
When was the last system review? Who signed it? What did it cover? If the answer takes more than a minute, you have a 483 risk.
How it works, step by step6 steps
How a V5 release moves through validation lifecycle.
- Release notes. Each release comes with release notes. With Enterprise, IQ/OQ and validation support follow the scope in your quote.
- Your team assesses impact. Your team reviews the release against its configuration and records the impact on a change.
- Your team tests. Your team runs IQ/OQ and its own PQ; evidence is captured with the records.
- Evidence Kept Together. Test evidence and approvals are linked to the change record.
- QA Signs the Package. QA reviews and signs the validation package and decides when the system goes into use.
- Change Control. Change records capture scope; your change control decides what each update needs, including any re-testing or PQ.
What to look for when choosing
Validation lifecycle management is where most GxP IT spend is wasted: paper protocols, manual execution, six-figure consultancies per release.
Clear Split of Validation Work
Which validation documents does the vendor provide, and which does your team own? Your team owns the URS. Enterprise includes IQ/OQ and validation support; exact deliverables are set in your accepted quote/SoW. Your team plans, runs and approves intended-use validation and PQ as applicable.
IQ/OQ Support
Does the vendor support installation and operational qualification? Enterprise includes IQ/OQ and validation support; exact deliverables are set in your accepted quote/SoW. Your team plans, runs and approves intended-use validation and PQ as applicable.
Release changes under your control
How do you decide what each update needs? Release notes describe changes; your change control decides any regression testing and PQ needed for your use.
GAMP 5 Category Alignment
Who assesses the GAMP category and the validation effort? Your team assesses the GAMP category and validation effort for its configured use.
Risk-based validation effort
Does the system support risk-based effort scaling per ICH Q9? Risk assessments can be recorded; your team decides validation depth.
Linked Validation Records
Can change records, test evidence and approvals be kept together? Change records, evidence and approvals can be linked in V5; your team maintains its requirements traceability.
Change Control Linked to Re-Validation
Does change control automatically scope the affected validation impact? Change records capture impact scope; your team decides what to re-test.
Validation Evidence on Request
Can you present your validation evidence when asked? V5 keeps the IQ/OQ documentation and audit evidence together; your team keeps its own PQ and approvals with it.
V5 Compared with Other Approaches
VLM compared across three options.
| capability | spreadsheet | legacy Qms | v5 |
|---|---|---|---|
| Validation support | None | Varies | Enterprise IQ/OQ and validation support, scoped in your quote |
| Re-testing after updates | Manual | Manual | Decided by your change control |
| Requirements ownership | Customer | Customer | Customer |
| PQ and intended-use validation | Customer | Customer | Customer |
| Change control impact | Manual | Manual + lookup | Recorded on the change; people decide |
| Annex 11 + Part 11 dual coverage | Two sets | Two sets | One architecture |
Regulations this supportsYour quality team stays responsible for compliance
VLM-relevant clauses.
21 CFR Part 11 §11.10(a)
Enterprise includes IQ/OQ and validation support; exact deliverables are set in your accepted quote/SoW. Your team plans, runs and approves intended-use validation and PQ as applicable.
EU GMP Annex 11 §4.1
Enterprise includes IQ/OQ and validation support; exact deliverables are set in your accepted quote/SoW. Your team plans, runs and approves intended-use validation and PQ as applicable. Your team owns the validation report.
EU GMP Annex 11 §4.4
Your team writes and approves the URS for its intended use.
GAMP 5 (2nd ed.) §3
V5 can hold change, document and approval records for your lifecycle; your team plans and approves the validation.
ICH Q9(R1) §V
Risk assessments can be recorded with the change; your team decides the validation effort.
PIC/S PI 011-3 §6
Release notes and Enterprise IQ/OQ support with each release; your team decides risk-based regression, PQ and re-validation under change control.
Standards Referenced
- 21 CFR Part 11 (electronic records & signatures)
- EU GMP Annex 11 (computerised systems)
- GAMP 5 (validation lifecycle)
- ICH Q9 (quality risk management)
- PIC/S PI 011 (good practices for computerised systems)
Common questions4 answers
- What is validation lifecycle management?
- It's the discipline of qualifying a computerised system through its entire life — requirements, design, installation, operational and performance qualification, change control, and periodic review — under GAMP 5 and 21 CFR Part 11 / Annex 11.
- Which plan includes IQ/OQ and validation support?
- Enterprise. Enterprise includes IQ/OQ and validation support; exact deliverables are set in your accepted quote/SoW. Your team plans, runs and approves intended-use validation and PQ as applicable.
- Do we re-validate on every V5 release?
- Your change control decides what each update needs, including any PQ. Enterprise includes IQ/OQ and validation support; exact deliverables are set in your accepted quote/SoW. Your team plans, runs and approves intended-use validation and PQ as applicable.
- Is V5 aligned with GAMP 5?
- Yes — risk-based, lifecycle-driven validation following the GAMP 5 V-model, with supplier-leveraged documentation reducing customer effort.