Industries · UK & Europe
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
Aligned to UK regulation
ORCA Opti maps to the frameworks UK organisations are measured against, and keeps your evidence current.
UK GDPR & Data Protection Act 2018
UK GDPR & Data Protection Act 2018
Personal data obligations and ICO expectations, mapped and evidenced.
Cyber Essentials & Cyber Essentials Plus
Cyber Essentials & Cyber Essentials Plus
The NCSC baseline controls many contracts now require, kept audit-ready.
NIS Regulations
NIS Regulations
Network and information systems duties for operators of essential services and digital providers.
ISO 27001
ISO 27001
Information security management, pre-mapped to your controls.
AI governance
AI governance
A practical path to safe, accountable AI aligned with the UK's pro-innovation approach.
UK & EU data residency
UK & EU data residency
Keep data in your Safe Zone, hosted in the UK or the EU under the EU Data Boundary, with residency you can demonstrate.
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 UK & Europe.
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