Why validate with Fiscal Ox
Risk‑based & right‑sized
We tailor effort by impact and complexity to avoid over‑ or under‑validation.
End‑to‑end ownership
From VMP and URS to IQ/OQ/PQ execution evidence and VSR sign‑off.
Audit‑ready evidence
Traceability, deviations/CAPA, and raw data packaged for inspections.
SaaS & supplier assessments
Vendor audits, SOC 2/ISO review, and Part 11 capability confirmation.
Data integrity (ALCOA+)
Controls for attributable, legible, contemporaneous, original, accurate data.
Change & periodic review
Release validation, impact assessments, and ongoing control.
- Validation Master Plan (VMP)
- User Requirements Spec (URS)
- Functional/Design Specs (FS/DS)
- Risk Assessment / FMEA
- Installation Qualification (IQ) Protocol & Report
- Operational Qualification (OQ) Protocol & Report
- Performance Qualification (PQ) Protocol & Report
- Traceability Matrix (URS → Test Cases)
- Deviation & CAPA logs
- Training Records & SOP updates
- Validation Summary Report (VSR)
- Periodic Review Plan
New System CSV
Full life‑cycle V‑model validation for COTS, SaaS, or custom solutions.
Upgrade / Change Control
Impact assessment, targeted re‑validation, regression OQ, release report.
SaaS Supplier Assessment
DQ/Supplier audit, SOC 2/ISO review, Part 11 matrix, and controls mapping.
Spreadsheet Validation
Requirements, risk, test scripts, version control & access procedures.
- GAMP 5: A Risk‑Based Approach to Compliant GxP Computerized Systems
- FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures)
- EU GMP Annex 11 (Computerised Systems)
- ISO 13485 / 21 CFR 820 context for medical devices (as applicable)
We align validation to applicable guidance and your internal QMS. We do not offer legal advice.
Our 5‑step CSV process
FAQs
Can you validate SaaS systems?
Yes. We perform supplier assessments and confirm Part 11/Annex 11 controls, then validate configuration, interfaces, and intended use.
Do you provide templates?
We provide right‑sized templates for VMP, URS, specs, risk, IQ/OQ/PQ, traceability, deviations/CAPA, and the VSR—aligned to your QMS.
How long does CSV take?
Simple spreadsheets may complete in 1–2 weeks. New COTS/SaaS systems with interfaces typically run 4–8 weeks depending on risk and resources.
Can you support audits?
Yes. We prepare evidence packs, walk through rationale and traceability, and support responses to findings.
Need IQ/OQ/PQ and validation reports?
Share the basics and we will send a tailored validation plan.