Use Cases

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  Biotech Using SaaS Clinical Platforms with No Validation Strategy

  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

  1. Discovery assessment across your full technology portfolio — not just one system
  2. Risk classification of each platform using CSA/GAMP 5 intended-use methodology
  3. Gap analysis identifying specific control deficiencies, documentation failures, and evidence gaps
  4. Remediation architecture — a prioritized action plan with realistic timelines, organized by regulatory risk
  5. Vendor qualification framework covering supplier documentation, cybersecurity posture, and ongoing oversight
  6. 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

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  GxP Software Vendor Pursuing ISO 27001 Certification

  The Situation

  You’re a GxP software vendor — clinical data, lab management, or regulatory tech. Your largest customers are asking for ISO 27001 certification. Maybe it’s showing up in RFPs. Maybe a key account flagged it during vendor qualification. You know you need it, but your team has never been through certification and you’re not sure how to scope it without over-engineering or missing critical gaps.

  What Goes Wrong Without Help

  • Scope is defined too broadly, creating unnecessary work and delaying certification
  • Security controls are implemented in isolation from your existing QMS and SDLC, creating parallel systems that don’t integrate
  • Documentation is written to “check the box” without reflecting actual operations — auditors see through this immediately
  • Internal audit capability is overlooked, leaving you unprepared for surveillance audits after certification
  • The gap between ISO 27001 requirements and GxP expectations (data integrity, audit trails, change control) isn’t bridged

  What Driftpin Does

  1. Gap assessment against ISO 27001:2022 controls, scoped to your actual operations and risk profile
  2. Remediation plan prioritized by certification impact — what the auditor will look for first
  3. ISMS documentation — policies, SOPs, work instructions, and reference documents aligned to how your team actually works
  4. Controls implementation — access management, vulnerability scanning, backup/DR, vendor management, incident response
  5. Internal audit program — build the capability your team needs for ongoing compliance
  6. Certification audit support — preparation, mock audits, and presence during the certification audit

  Typical Engagement

  Duration: 4-8 months from gap assessment through certification

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  Regulated Organization with No Supplier Management Framework

  The Situation

  You’re a pharma, biotech, or CRO with 30-60 technology suppliers — and you’re managing them in spreadsheets. Vendor qualification is inconsistent. Some suppliers were qualified years ago with no re-assessment. Others were never formally qualified at all. You have an audit coming and you know supplier management will be scrutinized.

  What Goes Wrong Without Help

  • Supplier inventory is incomplete — shadow IT, departmental purchases, and inherited contracts mean you have more suppliers than you think
  • Risk classification is missing — all suppliers are treated the same regardless of their impact on GxP data, patient safety, or regulatory exposure
  • Qualification evidence is scattered across shared drives, email, and individual laptops
  • Cybersecurity posture of key suppliers hasn’t been assessed — HIPAA Security Rule gaps are invisible
  • No ongoing monitoring — supplier risk profiles change but your records don’t

  What Driftpin Does

  1. Supplier inventory — comprehensive identification of all technology vendors, including inherited and shadow IT
  2. Risk classification based on GxP impact, data access, patient safety exposure, and regulatory criticality
  3. Gap assessment of current qualification evidence against regulatory expectations
  4. Framework design — supplier qualification, risk assessment, ongoing monitoring, and re-qualification processes
  5. Platform implementation using AtumCell for automated assessment, continuous monitoring, and audit-ready reporting
  6. HIPAA Security Rule readiness assessment for suppliers handling PHI

  Typical Engagement

  Duration: 2-3 months for framework design; 3-6 months through platform implementation

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  Software Vendor That Needs Senior Quality Leadership but Can't Justify Full-Time

  The Situation

  You’re a GxP software vendor — maybe 20-80 employees. You’ve built a solid product, but your enterprise customers are asking harder questions about your quality system, validation approach, and compliance posture. You need someone who can build and lead a quality program, interface with customers during audits and qualification, and provide strategic direction — but a full-time VP of Quality doesn’t fit your budget or headcount plan.

  What Goes Wrong Without Help

  • Quality responsibilities fall to developers or product managers who don’t have the regulatory background
  • Customer audits and qualification questionnaires take weeks to respond to — and the responses lack confidence
  • Your QMS (if you have one) exists on paper but doesn’t drive actual behavior
  • Validation strategy is reactive — you build evidence packages when customers demand them, not proactively
  • ISO certification stalls because nobody owns the program end-to-end

  What Driftpin Does

  1. Fractional VP of Quality / Head of QA — ongoing executive leadership at a fraction of full-time cost
  2. QMS establishment or remediation — build or fix quality systems that work for your size and maturity
  3. Customer-facing quality leadership — lead audit responses, qualification support, and compliance discussions
  4. Validation strategy — define your CSV/CSA approach and build repeatable evidence packages
  5. ISO certification ownership — drive 27001 or 9001 programs from gap assessment through certification
  6. Team development — build internal quality capability so the role can eventually transition

  Typical Engagement

  Duration: 6-12 months, typically 2-3 days per week

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  US Life Sciences Tech Company Expanding into Europe

  The Situation

  You’re a US-based life sciences technology company — SaaS, AI/ML tools, or clinical platforms — with European customers asking you to operate in the EU. Or you’ve decided to establish an EU presence to compete for European pharma and biotech accounts. Either way, you’re facing a regulatory landscape that doesn’t map neatly to what you know from FDA.

  What Goes Wrong Without Help

  • Entity structure is chosen for tax efficiency without considering regulatory implications
  • NIS2 Directive requirements are discovered after go-live, creating urgent and expensive remediation
  • EU AI Act classification and compliance obligations are underestimated — especially for clinical AI tools
  • Talent strategy doesn’t account for EU labor law, works councils, or local compliance staffing needs
  • ISO and GxP compliance approaches built for the US market don’t satisfy EU customer expectations
  • Data residency, GDPR, and cross-border transfer requirements create architectural surprises

  What Driftpin Does

  Through Europa Advisory — where Kevin Shea is a partner — we provide: