Regulatory Inspection Services

As an extension to our IT Quality Assurance Services we can help you prepare for and manage your European based Regulatory Inspections.

Mock Inspections

Whether it is part of your Inspection Readiness Initiative, or as part of preparing for an upcoming inspection, a Mock Inspection by A1 IT Compliance can ensure your team is ready and in control. Whether it is as a member of a larger Mock Inspection team, or a specialised IT Quality Assurance Inspection A1 IT Compliance can help!

We've got experience in working with Investigators, Charities, Government Funded Research Facilities and Pharmaceutical Research & Development and Informatics groups prepare for Inspections, from the networks to global computer systems:

• Development of Mock Inspection Plans / Agenda
• Conducting Onsite Mock Inspections & Inspection Readiness Assessments
• Mock Inspection / Inspection Readiness Reporting and Remedial Action Recommendations
• Review of CAPA Responses

Inspection Support

Even with the best preparation, there are always unexpected requests during regulatory inspections, but with A1 IT Compliance as an integral War room team member, getting unexpected requests doesn't have to be a problem.

Our Inspection Support Services include:

• Development of IT / Validation Inspection Finding Reponses
• Inspection War / Support Room Management / Co-ordination (Request / Document Tracking)