Identity that survives the GxP inspection.
IAM programs for pharma, biotech, and medical device manufacturers. 21 CFR Part 11, EU Annex 11, GxP, HIPAA, and ICH-GCP aligned across R&D and manufacturing.
- 21 CFR Part 11
- EU GMP Annex 11
- GxP
- ICH-GCP
- HIPAA
- NIST 800-53
Use cases we have shipped in life sciences.
- Use case · 01
Electronic records + electronic signatures (Part 11)
Access control and electronic signature workflows engineered to satisfy 21 CFR Part 11 §11.10 (closed system controls) and §11.50 (signature manifestation). Validation evidence captured per control.
- Use case · 02
Clinical trial system access governance
Role-based access reviews for CTMS, EDC, and eTMF platforms — typically Veeva Vault, Medidata, or Oracle Health Sciences. Investigator, monitor, and sponsor populations governed with the right separation.
- Use case · 03
GMP manufacturing system access
Access governance for MES, LIMS, and validated production systems. Operator / supervisor / quality role boundaries aligned to your GMP procedures; change control wired into IGA.
- Use case · 04
Research data + IP segmentation
Access governance for research data lakes, lab notebooks, and intellectual property repositories. Need-to-know enforcement engineered with audit evidence for each access grant.
- Use case · 05
Contract research organization (CRO) identity
Identity governance for CRO partners working on sponsor studies. Time-bounded access aligned to study lifecycle; protocol-amendment-driven re-attestation.
- Use case · 06
PV / safety reporting system access
Pharmacovigilance and safety reporting system access governance. Reviewer / authorizer / submitter separation aligned to E2B(R3) workflow and ICSR audit expectations.
- Use case · 07
Medical device + SaMD identity
Identity flows for medical device cloud platforms and Software-as-a-Medical-Device (SaMD) applications. FDA cybersecurity premarket guidance and IEC 62443 alignment engineered in.
The buyer archetypes we have shipped programs for.
We hold NDA on most engagements. Tiers below reflect the buyer archetypes we have shipped programs for. References available on request, after mutual NDA.
- TB
Tier-1 US Bank
FFIEC · SOX
- CB
Custody Bank
GLBA · FFIEC
- FA
Federal Agency
FedRAMP High
- SS
State System
StateRAMP
- HS
Top-10 Hospital
HIPAA · HITRUST
- HP
Health Payer
HIPAA
- FP
FinTech Platform
PCI-DSS · SOC 2
- AM
Asset Manager
SOX · SOC 2
Practices that anchor this industry.
Common questions.
Do you have direct experience with 21 CFR Part 11 expectations?+
Yes. Every life-sciences IAM program we deliver against validated systems is mapped to 21 CFR Part 11 §11.10 and §11.50, plus the equivalent EU GMP Annex 11 controls. Deliverables include the validation evidence and audit-trail artifacts FDA and EMA inspectors will request directly.
How do you handle CSV (computer system validation) for IAM tooling?+
We deliver CSV-aware IAM with risk-based validation per GAMP 5. The IGA / PAM platform itself is treated as a quality system; the validation effort is right-sized to the GxP risk classification of the access pathways it governs. We engage with your QA function from kickoff.
Can you support Veeva, Medidata, and Oracle Health Sciences integration?+
Yes. We have shipped IGA integrations against all three. Veeva Vault has the most polished SCIM and lifecycle integration; Medidata and Oracle Health Sciences require more bespoke work but are well within scope.
How do you handle CRO partner identity?+
CRO identity is a B2B-style scenario with the regulatory rigor of internal sponsor systems. We engineer protocol-bound access — sponsor governs which CRO populations have which study access, with attestation tied to protocol amendments. Audit evidence is captured per access decision.
What is a typical engagement timeline for a tier-2 pharma?+
12-week diagnostic against your validated-system landscape and quality system, then phased build over 6-9 months. Audit-ready evidence by month nine on the first GxP-scope; broader rollout follows on the next inspection-cycle planning horizon.
Ready to scope a life sciences engagement?
Same-day reply during business hours. NDA on request before discovery.