Process Development/ Auditing
Quality Management in the regulated clinical and drug safety environment focuses on the establishment of a system which ensures that the regulatory requirements in terms of timelines, format and quality are met. The availability of appropriate Quality documents (SOPs, Work Instructions), the implementation of training systems, quality control measures and regular performance of system audits are all essential for ensuring the quality standard of each company.
Quality Management services offered by HilbransConsulting include:
- Audits of pharmacovigilance systems and processes
- Preparation and follow-up of of pharmacovigilance inspections
- Review and advice on systems and processes
- Quality management in pharmacovigilance according GVP and GCP
- Generation, review and further development of SOPs
- Workflow management and optimisation
- Quality control of documents
- Training