Quality Compliance Suite

AXSource

GMP quality compliance suite to meet FDA, Health Canada and EU compliance requirements.

Quality and Compliance solution for Dynamics 365, designed and developed by regulatory experts to ensure compliance with GxP regulations including FDA 21 Code of Federal Regulations (CFR) Part 11, Health Canada and EMA. It allows system wide business data to be leveraged for quality management and quality improvement initiatives as well as production.

Features

Electronic Batch Records

Production Instructions

Environmental monitoring

Yield calculation and reconciliation

Deviation management

Recall Management

Corrective Action and Preventative Action (CAPA)

Approved Customer

Electronic Signatures


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