Industries ยท United Kingdom
Life Sciences & Pharma
Protect research, IP and patient data across life sciences. ORCA Opti brings your risks, controls and AI governance into one living system of record, inside your Safe Zone.
Regulation
Frameworks built in
ORCA Opti ships with the frameworks UK organisations are measured against, and keeps your evidence current.
Privacy (ISO/IEC 27701)
Privacy (ISO/IEC 27701)
Privacy impact assessments over your data processing, with privacy controls managed against ISO/IEC 27701.
CIS Controls & NIST CSF
CIS Controls & NIST CSF
Recognised baseline security controls, each one owned, tested and evidenced.
Incident management
Incident management
Incidents recorded with an owner, priority, and regulatory and contractual impact, so the record is ready when someone asks for it.
ISO 27001
ISO 27001
Information security management, pre-mapped to your controls.
AI governance (ISO/IEC 42001)
AI governance (ISO/IEC 42001)
Responsible, accountable AI, with an AI system inventory and impact assessments managed against ISO/IEC 42001.
Your data stays in your Safe Zone
Your data stays in your Safe Zone
Your documents and data are not copied to an outside system, and nothing is used to train external AI models.
For Life Sciences & Pharma across the UK and Europe
See ORCA Opti for UK & European Life Sciences
Pharma, biotech, CDMOs, medical device makers and contract research organisations across the UK and EU operate under MHRA, EMA, EU MDR and IVDR, EU AI Act for medical AI, plus USFDA expectations for the world's largest market. ORCA Opti brings data integrity, quality and security into one Pan-European programme.
Data integrity, ALCOA+ ready
Data integrity, ALCOA+ ready
EU Annex 11, 21 CFR Part 11 and GAMP 5 data integrity controls mapped, so MHRA, EMA and USFDA inspections land cleanly.
R&D, batch records and IP in the Safe Zone
R&D, batch records and IP in the Safe Zone
Molecule research, formulation records and CMO documents stay inside the Safe Zone, with AI Guardian blocking accidental disclosure to external AI.
MHRA, EMA and global audits
MHRA, EMA and global audits
Inspection-ready evidence for MHRA inspections, EMA inspections and global customer quality audits, kept current between visits.
EU MDR, IVDR and EU AI Act
EU MDR, IVDR and EU AI Act
EU Medical Device Regulation, IVDR and the EU AI Act mapped together for device makers and AI-enabled medical software.
The pressure
What life-sciences QA and IT directors face
Inspector expectations beyond paper, AI in research and quality systems, and the EU AI Act now in the room.
MHRA, EMA and USFDA inspections
MHRA, EMA and USFDA inspections
Data integrity findings drive most regulatory observations. Without evidence-grade controls, a single observation can lose a market for years.
Global customer quality audits
Global customer quality audits
Innovator pharma customers, US distributors and EU marketing authorisation holders audit quality systems annually. Evidence must be ready and trusted.
IP and formulation leakage
IP and formulation leakage
Molecule formulations, process IP and clinical data leaking to external AI tools is the new top exfiltration risk.
EU AI Act for medical AI
EU AI Act for medical AI
AI-enabled medical software is high-risk under the EU AI Act, with transparency, risk-management and post-market monitoring requirements stacking on top of MDR/IVDR.
Frameworks built in
Inspection-ready, every cycle
ORCA Opti ships with the standards UK and European life sciences actually run on. Controls pre-mapped, evidence structured and reporting current.
MHRA & EMA GxP
UK MHRA and EU EMA Good Manufacturing, Laboratory and Clinical Practice records mapped to a living quality system.
EU Annex 11 & 21 CFR Part 11
Computerised system validation, electronic records and electronic signatures aligned to UK, EU and US expectations.
GAMP 5 & ISPE
GAMP 5 second edition computerised system lifecycle and ISPE good practice guides mapped to controls and management review.
EU MDR & IVDR
EU Medical Device Regulation and In Vitro Diagnostic Regulation post-market surveillance, vigilance and PMCF records assembled.
EU AI Act for medical AI
High-risk AI system classification, risk management, transparency, robustness and post-market monitoring duties mapped to controls.
ISO 9001, ISO 13485 & ICH
Quality management for pharma and devices plus ICH Q7-Q12 guidelines mapped to one connected programme.
See ORCA Opti for Life Sciences & Pharma in United Kingdom.
Work through a guided check with Opti Assist and get an immediate view of where you stand.
Join our mailing list
News and updates from ORCA Opti.