Quality & Compliance For Microsoft Dynamics 365
D365 QCS™ combined with Microsoft Dynamics is a complete solution to serve the complex Global Regulatory / Quality and Compliance requirements of Life Sciences companies. Our ERP software, developed by AXSource®, meets FDA, Health Canada and EU compliance requirements.
Quality & Compliance For Microsoft Dynamics 365
D365 QCS™ combined with Microsoft Dynamics is a complete solution to serve the complex Global Regulatory / Quality and Compliance requirements of Life Sciences companies. Our ERP software, developed by AXSource®, meets FDA, Health Canada and EU compliance requirements.
D365 QCS™ Features
CAPA Management
Manage Non-Conformances & Deviations with on-line Corrective Actions & Preventative Actions
Electronic Batch Records
Capture manufacturing & environmental details from raw material / components thru to finished packaging complete with e-signatures
Enhanced eSignature
Authorize and maintain security at sign-off points necessary in Production & Quality Control
Recall Management
Most effective management of recalls
Computer System Validation (CSV)
Validation package with verification on-site. Regulatory and compliance support for requirements not yet included or unique to client
Read More
Deviation Control
In process control of master formula
Sample Management
Authorize and maintain security at sign-off points necessary in Production & Quality Control
Read More
Regulatory & Quality Reporting
Industry compliance documents
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