Quality & Compliance For Microsoft Dynamics 365

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developed by AXSource®, meets FDA, Health Canada and EU compliance requirements.
Regulatory / Quality and Compliance requirements of Life Sciences companies. Our ERP software,
D365 QCS™ combined with Microsoft Dynamics is a complete solution to serve the complex global

D365 QCS™ Features

CAPA Management

CAPA Management

Manage Non-Conformances & Deviations with on-line Corrective Actions & Preventative Actions

Electronic Batch Records

Electronic Batch Records

Capture manufacturing & environmental details from raw material / components thru to finished packaging complete with e-signatures

Enhanced eSignature

Enhanced eSignature

Authorize and maintain security at sign-off points necessary in Production & Quality Control

Recall Management

Recall Management

Most effective management of recalls

Computer System Validation (CSV)

Computer System Validation (CSV)

Validation package with verification on-site. Regulatory and compliance support for requirements not yet included or unique to client

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Deviation Control

Deviation Control

In process control of master formula

Sample Management

Sample Management

Authorize and maintain security at sign-off points necessary in Production & Quality Control

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Regulatory & Quality Reporting

Regulatory & Quality Reporting

Industry compliance documents

Environmental Monitoring

Environmental Monitoring

Control of environment for compliance

Why D365 QCS™

WE ARE THE LIFE SCIENCES

Unlike usual solutions developed by IT experts to meet industry requirements, D365 QCS™ is designed and developed by AXSource’s regulatory and compliance experts with prior GxPs implementation, auditing and validation experience globally.

  • Validated solution saves in costs of a separate validation effort with multiple partners
  • Complete solution for Life Sciences compliance requirements with compliant processes are ready for implementation

Enhancing  Microsoft Dynamics

Complete ERP Solution

D365 QCS™ seamlessly integrates with Microsoft Dynamics, improves the standard functionalities and adds life sciences specific functionalities to bridge the requirement gap and design elements that are missing in standard ERPs, but required for Life Sciences companies. It streamlines production and quality management to ensure compliance with global GxP regulations including FDA 21 Code of Federal Regulations (CFR) Part 11, Health Canada and EU Compliance requirements.

Microsoft Dynamics 365

Flexibility

Startup to Enterprise level, implement a scalable
Tier 1 ERP

Agility

Faster implementation with ability to be deployed in increments or at once

Features

Functionally rich enterprise resource planning system

Support

Delivered by Microsoft Global Partners Network