Our Approach to Computer System Compliance Assessments

Our audit experts follow the risk-based GxP principles laid out by PIC/S, ICH, EMA and the FDA, to prioritize the processes and systems to assess. We know which areas auditors are most likely to target and apply the following approach to assessing your systems and software validation procedures.

• Meet with you to discuss your industry, your products, and your markets to determine the quality regulations and standards with which you need to comply. E.g., 21 CFR Part 11, 820, or 211, Eudralex Annex 11, ISO 13485.

• Identify any specific areas of concern. For example, you might feel fairly confident about your software quality policies, but are uncertain whether or not your validation documentation will withstand serious scrutiny.

• Tailor our standard 200+ question assessment checklist to place the focus on the areas that are most important to you.

• Conduct the Assessment in a manner similar to a regulator or potential customer. We ask the same tough questions, inspect your evidence, and challenge your practices.

• Provide an Assessment Report with ratings for each question. Areas of non-compliance will be categorized as either “critical”, “major”, or “minor” in alignment with a risk-based compliance program.

• Deliver a System Compliance Action Plan with a list of specific, prioritized activities to complete prior to your audit.

• Follow-up meeting to ensure that you understand the assessment results and recommended remediation approach.

We can assess your systems either at your site or remotely – whichever fits your needs and budget.

Assessments Results

• The benefits of a Part 11 or Annex 11 Gap Assessment include:

• Time to proactively remediate any critical deficiencies before the audit, rather than having them discovered by a regulator or customer

• Insight to focus audit preparation activities on only those areas that need attention

• Confidence in the success of your next audit or inspection