Post-Approval
Operations & Inspections
CyberGXP helps organisations maintain secure, compliant operations after approval, ensuring systems remain inspection-ready and resilient throughout the product lifecycle.
Regulatory approval is not the end of cyber risk — it is the point at which ongoing oversight begins.
Post-approval operations introduce continuous regulatory scrutiny across manufacturing, quality, pharmacovigilance, and supply chain systems. Cyber security failures at this stage can result in inspection findings, warning letters, supply disruption, or loss of regulatory confidence.
What You’re Protecting
Post-Approval
Following approval, regulated systems continue to support critical operations under ongoing regulatory oversight.
Key assets include:
GMP manufacturing and quality systems
Pharmacovigilance and safety reporting platforms
Change control and deviation management systems
Supply chain and distribution systems
Ongoing data retention, archival, and access controls
Systems supporting regulatory reporting and oversight
These systems must remain secure, controlled, and defensible long after approval is granted.
Cyber Risks During
Post-Approval Operations
Post-approval environments often evolve rapidly as organisations scale, optimise, and respond to market demands — increasing cyber risk if controls are not maintained.
Common risks include:
Cyber incidents impacting validated and regulated systems
Inadequate control of system changes post-approval
Loss of data integrity over time
Third-party and supplier cyber risk
Insufficient monitoring and logging to support inspections
Incident response gaps during regulatory scrutiny
Even small cyber weaknesses can escalate quickly during an inspection.
How CyberGXP Supports
Post-Approval Operations
Our approach is designed for long-term compliance and operational resilience.
CyberGXP supports post-approval environments through:
Post-approval cyber risk assessments
Continuous monitoring and logging assurance
Secure access and privilege management
Change control and validation-aligned security controls
Incident readiness and regulatory response support
Inspection preparation and audit support
We help organisations maintain compliance without disrupting live operations.
Regulatory & Compliance Expectations
Regulators expect organisations to demonstrate ongoing control of systems and data throughout the post-approval lifecycle.
CyberGXP supports alignment with:
GMP and GxP expectations
Data integrity principles (ALCOA+)
Change management and validation maintenance
Continuous inspection readiness
Global regulatory oversight and inspection requirements
Cyber security must support defensibility — not create new findings.
Staying Inspection-Ready
Inspections can occur at any time — often with little notice. Cyber security weaknesses discovered during inspections can lead to observations, remediation demands, or enforcement action.
CyberGXP helps organisations stay inspection-ready by embedding cyber security into day-to-day regulated operations.
Protecting Long-Term
Regulatory Confidence
Sustained regulatory confidence is built over time. Secure, well-governed post-approval operations protect product supply, patient safety, and organisational reputation.
Cyber security must evolve alongside operational and regulatory change.
Maintain Compliance.
Withstand Scrutiny.
If you’re operating post-approval and need to ensure systems remain secure, compliant, and inspection-ready, speak to CyberGXP. We’ll help you protect operations today — and stand up to inspection tomorrow.