Computer System Validation Compliance Audit of Cloud Systems

Computer System Validation Compliance Audit

The Brevitas team conducted a Computer System Validation audit on two recently updated and validated cloud systems. The audit outlined the gaps in the validation packages and provided remediation actions and recommendations to bring the systems into compliance.

Industry

Natural Healthy Product

Area of Expertise

Regulatory Affairs & Compliance

Duration

8 weeks

Services Provided

  • Compliance Audit
  • Computer System Validation

Impact

Based on a thorough audit, Brevitas was able to provide the client with a list of actionable items to improve in the validation of their software to meet regulatory compliance.

Business Challenge

Our client enlisted Brevitas consultants to perform an audit of the validation packages surrounding updates to the site’s Enterprise Resource Planning (ERP) and Quality Management System (QMS) software in order to identify any gaps and suggest remediation actions. Additionally, the audit is important for the end-users to validate any future software updates to maintain compliance.

Our Approach

The Brevitas team performed a virtual audit to identify regulatory and procedural gaps within the validation packages of the site’s in-house developed cloud-based ERP software and cloud-based QMS software. For each of the gaps identified, the Brevitas team provided a recommendation to remediate the gap. Recommendations for improving the current internal process were also provided to our client.

Results Achieved

Brevitas was able to provide our client with a clear path forward and a list of actionable items to bring the validation of the updated systems into a state of compliance. Additionally, Brevitas improved the client’s internal processes to facilitate consistent compliance in the future.

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