Pharma and life sciences — GxP, 21 CFR Part 11 and data-integrity security

Applicable regulations

• US FDA 21 CFR Part 11 and GxP data-integrity expectations
• CDSCO requirements for computerised systems in regulated operations
• DPDP Act 2023 for patient, trial and employee personal data
• ISO 27001 ISMS and SOC 2 for enterprise and partner assurance

Common cybersecurity risks

• Data-integrity failures in GxP computerised systems (ALCOA+)
• Unvalidated changes to manufacturing and LIMS/QMS platforms
• Exposure of clinical-trial and patient personal data
• Insecure interfaces between IT, lab instruments and OT
• IP theft of formulations and research data

Audit findings we typically see

• Incomplete audit trails and access controls in GxP systems
• Weak segregation between IT, lab and manufacturing networks
• No DPDP-aligned handling of patient and trial data
• Untested backup and recovery for validated systems
• No incident-response process spanning quality and security

Services required

• VAPT across enterprise, lab and OT systems
• ISO 27001 ISMS
• SOC 2 readiness
• DPDP compliance for patient and trial data
• Security architecture review

Our engagement approach

• Discovery. Inventory GxP and enterprise systems, data flows and interfaces; confirm 21 CFR Part 11, CDSCO and DPDP obligations.
• Assessment. Security testing and control-gap review mapped to data-integrity (ALCOA+), ISO 27001 and DPDP, without disrupting validated systems.
• Remediation. A prioritised, validation-aware roadmap for access, audit-trail and segmentation fixes.
• Assurance. Retest, audit-grade reporting and inspection-ready evidence.

Expected evidence

• System and data-flow inventory across GxP and enterprise IT
• Access-control and audit-trail review results
• VAPT reports with closure evidence
• DPDP and data-integrity control evidence

Deliverables

• Gap assessment mapped to 21 CFR Part 11, ISO 27001 and DPDP
• Validation-aware remediation roadmap
• VAPT reports with closure evidence
• Inspection-ready control evidence pack