Operational Quality Assurance

We support you as external ressource regarding your QA and QM activities. 

This covers (amongst others) following topics:

• Revision of the documents of your management system incl. related improvements
• Implementation of new (pharmaceutical) laws, norms guidelines and other standards
• Audits
• Qualification of suppliers and partners
• Measures related to change control, deviations and complaints
• PQRs (Product Quality Reviews)
• Management Review
• Quality Agreements
• Batch Review
• Internal Training
• Support of qualification and validation activities
• Support of risk assessments