
Expertise in Audit Support
Audit Support
If you're looking for an expert to assist you during audit preparation and the audit itself, you've come to the right place. At Normec, we stay on top of regulatory changes, track developments within our client portfolio, and provide targeted recommendations with specialised expertise in the relevant area.
AlainSenior GxP Consultant
When you talk about life sciences, you also talk about regulations. All quality systems and processes undergo thorough inspections by regulatory bodies (such as FAMHP or the FDA). Meeting these requirements involves not only a deep understanding of the regulations but also the expertise to implement them effectively in procedures and processes.
Audit Support
GAP assessment processes & quality systems
A screening of your processes and quality systems to create an action plan with recommendations based on that review.
Audit preparation
Implementing a plan of action
Developing/improving processes and procedures
Goal: comply with applicable regulations and current expectations within the domain, such as cGMP
Support during the audit
Answering questions during audits
Implementing CAPA plan

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