GxP Software Vendor Pursuing ISO 27001 Certification
A clinical SaaS vendor whose enterprise customers are demanding ISO 27001 but doesn't know where to start.
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
- Gap assessment against ISO 27001:2022 controls, scoped to your actual operations and risk profile
- Remediation plan prioritized by certification impact — what the auditor will look for first
- ISMS documentation — policies, SOPs, work instructions, and reference documents aligned to how your team actually works
- Controls implementation — access management, vulnerability scanning, backup/DR, vendor management, incident response
- Internal audit program — build the capability your team needs for ongoing compliance
- Certification audit support — preparation, mock audits, and presence during the certification audit
Typical Engagement
Duration: 4-8 months from gap assessment through certification
Outcome: ISO 27001 certification with an ISMS that integrates with your existing QMS and SDLC — not a parallel bureaucracy.