Get Ready for a Customer Audit
Need to pass a client audit of your systems?
If you are preparing for a customer audit, you may be worried your computer system validation documentation is weak or that your software quality assurance processes aren’t up to industry standards.
While software quality audits can be stressful, with the help of our team of experts you can rest assured of a successful outcome.
Our validation consultants will conduct a friendly, low-pressure audit. We’ll identify the compliance gaps that need to be corrected and tell you how to correct them.
Get help for your next customer audit"They landed a big client, but the deal was dependent upon passing an audit"
Client Success Story
A software vendor for clinical trial records management application had recently landed a new big-pharma client, but the deal was dependent upon passing an audit by the client’s Quality Assurance organization.
Six weeks before the audit, we assessed the software vendor’s computer system validation documentation and software quality assurance SOPs to identify areas of audit vulnerability. Utilizing the Compliance Action Plan we provided after our assessment, the software vendor was able to remedy the issues, pass the audit, and secure a new major client.
We know your customers’ audit requirements. Our consultants have over 20 years of experience on both sides of the audit table.
Our team will:
- Meet with you to discuss your industry, your products, and your markets to identify your quality regulations and industry standards, e.g., 21 CFR 11, Annex 11, ISO 13485, and GAMP V.
- Tailor our standard 300+ question assessment checklist to place the focus on the areas that are most critical for your customer audit.
- Conduct an Audit Readiness Assessment. We ask the same tough questions, inspect your evidence, and challenge your practices, just like your customer’s auditor, but with a friendly, helpful approach
- Provide an Assessment Report with ratings for each question. Areas of non-compliance are 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.
- Hold a follow-up meeting to ensure that you understand the assessment results and recommended remediation approach.
Get Help With Your Next Customer Audit
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Questions About Your Vendor Audit?
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