Once an audit readiness assessment has been completed, our team can immediately begin to address high-risk areas through remediation of SOPs, retrospective validation, training, and any other preparation needed for your system compliance audit.
System Compliance Audit Preparation
Whatever your specific challenges might be, we have the consultants, trainers, and validation experts available to get you inspection-ready.
- Computer System Validation process improvements
- Software quality assurance SOPs
- Retrospective validation of computer systems
- Validation training
If this is your first system audit, or if your last compliance inspection didn’t go so well, it can be reassuring to have a veteran, certified audit facilitator on site from the Opening Meeting to the Closing Meeting.
Our Approach to Compliance Audit Preparation
Our approach is flexible to your needs. We can either be there at your side, or coaching from behind the scenes. We can also provide back-room coordination services, such as staging documentation and preparing auditees.
What You Can Expect from Our Consultants
We’re familiar with audit tricks and techniques, and can help you steer clear of trouble by providing guidance for sticky situations, such as:
- Detection of regulatory deficiencies
- Discovery of non-compliance
- Requests for data and system access
- Requests for proprietary information