Let's face it, not all audits go well, but no matter what the outcome, identifying opportunities for improvement, is a positive step moving forward. On the flip side, having the green light and thumbs up from good audit findings, puts you and your team in a favourable position.

Our teams deliver first class, tailored solutions to put you in a win-win position.  So you can be armed with an effective audit program to help identify issues early on, reducing your compliance exposure and your cost of remediation.

We carry out a range of audits, benchmarking exercises and system health checks to include:

• Data Integrity  - Do your systems meet data integrity requirements?  Can you ensure data integrity for the lifetime of the data and its retention period?
• Governance and Framework - Why not leverage our expertise and involvement in GAMP to assist you with Policies, Strategic Plans, Project Definition and Planning.  We can support and guide you by assessing, reviewing and advising on your overall strategic approach. 
• Supplier Audits - Check before your purchase a system and manage/mitigate the on-going issues.
• In Project Audit - Are projects being implemented and validated according to agreed validation plans and quality procedures?
• 21 CFR Part 11 - Do you and your system comply with ERES requirements?
• Gap Analysis - Formal review of where you are vs where you want to or expect to be.
• Periodic Reviews - Review the operation, change management and validation maintenance of a system then proactively resolve issues and ensure optimum operation.
  System Health Checks - Are you operation and maintaining the validated status of your computer systems?
• Computer Systems Pre-Inspection - Are your computer systems and your documentation ready for inspection?  Are your staff ready to host an inspection?
• GMP Audits - We perform internal and external GMP audits against most recognised pharmaceutical standards.  We use specialist sector-specific consultants/auditors as needed, including IT/computer systems experts.
• CSV and GMP Pre-Inspection and Remediation - We help get sites ready for CSV and GMP regulatory and corporate inspections, including working with groups to get their own areas ready.