Industries ยท India
Pharmaceuticals
Protect data integrity across India's pharma industry. 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 international standards Indian organisations are measured against, and keeps your evidence ready.
Privacy (ISO/IEC 27701)
Privacy (ISO/IEC 27701)
Privacy impact assessments over your data processing, with privacy controls managed against ISO/IEC 27701.
Incident management
Incident management
Incidents recorded with an owner, priority, and regulatory and contractual impact, so the record is ready when reporting clocks start.
NIST CSF & CIS Controls
NIST CSF & CIS Controls
Recognised security frameworks, with every control owned, tested and evidenced.
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.
Data localisation
Data localisation
Keep regulated data where it needs to stay, inside your Safe Zone.
For Pharmaceuticals
See ORCA Opti for Indian Pharma
Indian pharma is the world's third-largest by volume and the largest supplier of generics to the US. With USFDA, EU EMA, the revised Schedule M and CDSCO all watching, plus IP-rich R&D pipelines and global CMO and CDMO contracts, every batch record and every system has to be evidence-grade. ORCA Opti brings data integrity, quality and security into one programme.
Data integrity, ALCOA+ ready
Data integrity, ALCOA+ ready
21 CFR Part 11, EU Annex 11 and revised Schedule M data integrity controls mapped, so USFDA and EMA 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.
USFDA, EMA and global customer audits
USFDA, EMA and global customer audits
Inspection-ready evidence for Form 483 responses, EMA inspections and global customer quality audits, kept current between visits.
Schedule M and WHO-GMP without spreadsheets
Schedule M and WHO-GMP without spreadsheets
Revised Schedule M, WHO-GMP and CDSCO records assembled in a living quality system, ready for inspection at short notice.
The pressure
What pharma QA and IT directors are facing
Inspector expectations have moved beyond paper. Every system in the value chain now has to demonstrate integrity, security and provenance under pressure.
USFDA Form 483 and Warning Letters
USFDA Form 483 and Warning Letters
Data integrity findings drive most Warning Letters. 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 your quality system every year. Evidence must be ready, current 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. AI Guardian shuts it down at the prompt.
Ransomware on manufacturing
Ransomware on manufacturing
Manufacturing is the most-attacked sector globally. Ransomware on MES, LIMS or batch-execution systems can halt production and create market-supply risk.
Frameworks built in
Inspection-ready, every cycle
ORCA Opti ships with the standards Indian pharma actually runs on, from CDSCO to ICH. Controls pre-mapped, evidence structured and reporting current.
Revised Schedule M & CDSCO
Revised Schedule M (2024), CDSCO licensing and Indian GMP records mapped to a living quality system.
21 CFR Part 11 & EU Annex 11
Electronic records, electronic signatures and computerised system validation evidence aligned to USFDA and EMA expectations.
WHO-GMP & PIC/S
World Health Organization GMP and Pharmaceutical Inspection Co-operation Scheme records assembled for global market access.
ISO 9001 & ISO 13485
Quality management for pharmaceuticals and combination devices, mapped to controls and management review cycles.
CERT-In & DPDP Act
6-hour incident reporting and personal data protection obligations integrated with quality and audit workflows.
ICH Q7-Q10, Q12 & Pharma 4.0
International Council for Harmonisation guidelines, product lifecycle management and digital pharma maturity models, supported as you scale.
See ORCA Opti for Pharmaceuticals in India.
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