Compliance

Ace your audits with fully-validated software and FDA-compliant features

Regulatory compliance is the law of the land in many manufacturing organizations and quality managers need to be cognizant of every aspect of their supply chain. CERDAAC Service Manager’s Compliance Module includes features designed to help lives-at-stake manufacturers meet regulatory requirements with ease.

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CERDAAC Software Compliance Module

Compliance Module Features

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Validation

Software validation can be burdensome and time-consuming. SIMCO fully handles validation of cloud-based CERDAAC software to cover FDA Part 11 and Part 820, so you don’t need to invest in expensive validation efforts. As new capabilities are added, SIMCO ensures they are validated prior to release.

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FDA-Compliant Electronic Signatures

Digital signatures use cryptographic authentication methods in order to verify the identity of the signer and prevent unauthorized users. Fields can be locked down and require approval again if changed. You can set signatures to be role-based, require multiple levels of signatures, and trigger alerts based on a signature to ensure approval.

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Ace Your Audits

Any modifications made to your records are immediately logged and captured in the audit trail so you can track changes and ensure proper documentation. SIMCO also provides validation/verification audit support in conjunction with Compliance Module to help you ace your audits.

“I can trust that all of the certificates in CERDAAC can pass an audit. The labeling is correct, the date a part was calibrated and the date due are all correct. We usually shine like stars through an audit as long as it’s a tool that is calibrated by SIMCO.”

Lisa Reid
Senior Quality Engineering Aid & Calibration Administrator
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Featured Resources

Interested in learning more about CERDAAC Software? Schedule a demo today to see how CERDAAC can meet your organization’s needs.