Biotech Using SaaS Clinical Platforms with No Validation Strategy
A growing biotech with multiple SaaS vendors, upcoming FDA interactions, and no structured CSV/CSA approach.
The Situation
You’re a biotech with 3-5 SaaS platforms supporting clinical operations — EDC, CTMS, eTMF, maybe a safety database. Each was adopted quickly during growth. None were formally validated. Your quality team knows there are gaps, but nobody has mapped them. An FDA pre-approval inspection is 12-18 months out.
What Goes Wrong Without Help
- Validation is attempted system-by-system in isolation, creating redundant and inconsistent evidence
- Teams default to legacy CSV approaches (full IQ/OQ/PQ for every system) because “that’s what we’ve always done”
- Vendor qualification is overlooked — supplier documentation gaps surface during inspection prep
- 21 CFR Part 11 compliance gaps (audit trails, electronic signatures, access controls) aren’t discovered until it’s too late to fix cleanly
What Driftpin Does
- Discovery assessment across your full technology portfolio — not just one system
- Risk classification of each platform using CSA/GAMP 5 intended-use methodology
- Gap analysis identifying specific control deficiencies, documentation failures, and evidence gaps
- Remediation architecture — a prioritized action plan with realistic timelines, organized by regulatory risk
- Vendor qualification framework covering supplier documentation, cybersecurity posture, and ongoing oversight
- Optional: Execution using ValKit for digital validation packages that are 80% faster and inspection-ready
Typical Engagement
Duration: 2-4 months for assessment and remediation plan; 4-8 months through execution
Outcome: A defensible validation program across your clinical technology portfolio, prioritized by risk, with evidence that holds up to FDA inspection.