Keep Track of your Nonconforming Products with QualiPro

by | Aug 5, 2019 | FDA, Quality Systems, Regulatory, Software

Nonconforming products happen but managing them before they spin out of control is important. With QualiPro you can manage non-conforming products with ease. It easily tracks products through all phases of the nonconformance process: description, analysis, investigation, decision, closure, and approval. Once a nonconformance report is created, QualiPro will systematically alert those with required tasks each step of the way.

If in the investigation phase it is decided that the nonconformance is a systemic issue, it can be linked to a CAPA for further analysis or a completed CAPA for further explanation. By linking the CAPA to the nonconformance, it creates a link inside the nonconformance report for easy reference.

A nonconformance report can also be linked to a supplier complaint. This may be done to easily identify that investigation by the supplier needs to be completed or has been completed. Like linking a CAPA, linking a supplier complaint creates a usable link for easy reference inside the nonconformance report.

After the investigation is completed, the disposition decision is made. QualiPro allows only pre-determined dispositions and approvers to be selected. Once it has been approved, the disposition is carried out and the nonconformance is closed and sent for final approval.

After final approval is completed, a nonconformance record is created and a notification is sent out to those specified as needing to be informed of the nonconformance. This allows for easy tracking of nonconformances from start to finish.

Need help managing your nonconformance process? We can help. Contact us at 248-987-4497 or info@emmainternational.com.

Jayme Brace

Jayme Brace

More Resources

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Abbreviated 510k submission

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