Is your organization due for a regulatory inspection soon?
Is your organization frequently subject to client audits or regulatory inspections?
Have you recently been inspected or audited and you need support?
In combination with a mock-inspection, company gap assessment or audit, or as a stand-alone activity (e.g. when your company has recently been inspected or audited), Rescop can support your organization in remediation activities, such as:
- Improvement of your Quality Management System (including support in e.g. CAPA or complaint handling, training and development of standardized procedures, a quality manual or other documents)
- IT infrastructure qualification
- Validation of any computerized systems (validation according to GAMP5 or agile)
- Support in other quality assurance activities (including internal and external auditing)
Support will be provided, in writing the response to an inspection (e.g. the FDA) or a client audit including development and execution of the corrective action plan, in case any observations were made.
If you want to learn how remediation activities will help your organization, contact us.