Protecting validated systems, clinical data, and regulated processes in one of the most compliance-intensive sectors.
Life sciences organizations must meet 21 CFR Part 11 for electronic records, GxP frameworks (GMP, GCP, GLP) governing validated systems, EU Annex 11 for computerized systems, and SOC 2 for service organization controls. Security controls must align without disrupting validation status.
GxP-validated manufacturing systems, LIMS, electronic batch records, and clinical trial platforms require specialized protection that respects validation boundaries and change control processes.
Controlling who can access validated systems - and proving it to auditors - is critical. Role-based access, MFA enforcement, and fully auditable access records are non-negotiable.
A security incident affecting a validated manufacturing line can halt production, compromise batch records, and trigger regulatory investigations. Operational continuity depends on proactive cyber risk management.