Auditing

Auditing is a key tool to maintaining compliance in the regulated industries. To demonstrate you are in control of your systems an effective audit program is essential. An effective audit program will help you identify issues early, reduce your compliance exposure and reduce your costs of remediation.

We at Clarity Compliance Solutions have vast experience in conducting audits for our clients. Following our Review – Advise – Deliver, we help our clients identify the issues, plan the remediation and provide skilled resources to provide the remediation.

Our team of auditors have carried out audits across most aspects of the regulated industries and they have years of experience with GAMP, FDA and MHRA regulatory expectations and requirements.

Our team deliver first class, tailored audit solutions:

• Supplier Audits
  Check before you purchase and manage/mitigate the on-going issues
• In Project Audits
  Are project validation plans and quality procedures being adhered to
• 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
• System Health Check
  Are you operating and maintaining the validated status of your computer systems
• Computer Systems Pre-Inspection
  Are your computer systems, your staff and your documentation ready for inspection
• GMP Audits
  We perform internal and external GMP audits against most recognised pharmaceutical standards We use specialist sector-specific auditors as needed, including experience IT/ Computer System auditors.
• 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.  Not all audits go well, and we can help get sites that have had poor inspections back on their feet.