Audit Program Management.
Scheduled compliance across your portfolio.

What is Audit Program Management?

An effective Audit Program is essential for pharmaceutical organizations with multiple products in various life cycle stages.

Each product within a company’s ‘Audit Universe’ possesses unique compliance obligations and the need for inspection readiness, or inspections themselves.

Click here for more information from the EMA on compliance requirements.

This requires the construction of an annual audit plan to guarantee that compliance audits for each product in that audit universe are communicated, planned, executed, and reported, with ongoing monitoring of outcomes.

The management of this comprehensive process can be handled internally or outsourced to an external supplier.

Why choose Aegisana to manage your Audit Universe?

Extensive & independent.

Aegisana’s experienced GxP compliance team can set-up, manage, and execute part of or all your audit program. Your program will be administered in-house with full responsibility for adherence to all contractual agreements such as timelines, budget, and quality.

Our experts have successfully managed numerous audit programs for small, medium-sized, and large companies, and we offer a wide pool of qualified internal or external auditors with a wealth of experience and best practice knowledge.

Independence is a pivotal principle that underpins our methodology and extends across all our auditing services. It constitutes a crucial component of our findings and recommendations.

A wide range of GxP areas.

We can manage the breadth of your Audit Universe across GCP, GVP/VGVP, GMP and GDP to provide a range of bespoke auditing options for the perfect solution, including risk benchmarking, Remote Auditing, report creation, external expert access, and more.

We can work with your procedures and templates as an extension of your own team, or with our own QMS system.

Our ultimate goal is to give you the confidence and peace of mind derived from employing a specialized and impartial service. This ensures the seamless operation of your audit program, keeping you in full compliance.