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Pharmaceutical Leader in Development of Human Therapeutic Products Australia
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Validation of ERP System - MS Dynamics NAV
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| Project Duration: |
2007 |
| Project Features: |
System for steamlining operations from a combination of paper and computer based systems to a uniform ERP system. |
| Works Included: |
The project was to implement and validate the complete Navision ERP system. The new system was intended to help streamline operations from a combination of paper and computer based systems to a uniform ERP system across all departments. The transition to the Navision ERP system would improve plant operations from both a business and an FDA/TGA regulatory perspective. |
Project Outline:
- Synertec provided its validation methodology based upon the ‘GAMP4 V model’ for automated systems but it also utilised a ‘risk-based’ approach. By taking a risk-based approach, Synertec ensured the validation effort was properly focused on the areas of the system that were most significant for product quality, safety and data integrity.
- With the introduction of electronic records and signatures, a critical part of Synertec’s validation strategy was to assess compliance with 21 CFR Part 11 regulations. The assessment was conducted not only from a technical standpoint, but also a procedural one ensuring the entire business process complied with FDA expectation.
- During the Navision ERP system validation, Synertec identified the underlying network infrastructure also required validation and a separate project was initiated. The objective of the Network Qualification project was to assure the network was suitable for its intended use and would satisfy TGA, FDA, Sarbanes-Oxley (SOX) regulatory requirements as well as the applicable business requirements.
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