We can help you set up and review your Quality Management System and also help you prepare for inspections.
QMS and SOP review
Setting up your QMS can be a daunting task. We have helped a number of startup Biotech companies to review their QMS and SOPs to check for GCP compliance and ensure that the relevant SOPs are in place at the right time. We can advise on which SOPs you will need in place and review your current SOPs against the relevant legislation and guidance to check for compliance.
It’s important to be prepared for inspections and the best preparation is to get the right systems and processes in place at the right time. We have helped organisations review the gaps likely to be identified in an inspection and then develop plans to plug those gaps. We do this by:
- Running workshops reviewing guidelines for inspectors and assessing inspection readiness
- Identifying Inspection Readiness gaps
- Facilitation of working groups to address gaps and report progress
- We can also organise a Mock Inspection to assess Inspection Readiness and train staff in inspection process and techniques
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