Major Nutraceuticals Company
Implements & Validates Microsoft Dynamics AX 2009
Case Study
Microsoft Dynamics AX 2009 ERP System Implementation & Validation
The goal of the system was to replace an obsolete system, improve operational efficiency, ensure compliance and establish new system to manage potency.
Replace obsolete hardware / software
Validate new system
Develop new enhanced capabilities for the management of potency
The deployment community consisted of quality and manufacturing personnel
21 CFR PART 111–Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements
21 CFR Part 11. There we about 66 users with only 6 PCs in production to start. The company was in transition to a Windows-based architecture across the enterprise
Edgewater Fullscope assembled a project team consisting of implementation professionals, validation consultants and deployment specialists to manage the project. Edgewater Fullscope was selected based on their deep domain experience in life sciences and their reputation as the leading partner for Microsoft Dynamics AX worldwide. Fullscope leveraged the SureStep methodology to help keep the project on time and within budget. A key criterion in the selection process was the vendors’ validation experience and the ability to rapidly conduct validation. Fullscope developed the FIRST validation toolkit for Microsoft Dynamics AX 2009 and was able to credibly demonstrate experience to the client.
The project objectives were to implement Microsoft Dynamics AX, develop new potency module and validate the system.
Purchase Toolkit and/or Automated Validation Software Tool
Did the client purchase the
FDA Validation Toolkit?
yes
Did the client purchase the automated
validation software tool?
no
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Methodology and approach
Fullscope’s implementation team leveraged SureStep methodology to drive the overall project deliverables. The team conducted a series of conference room pilots and workshops to ensure that all requirements were captured and documented. Functional and design specification documents were developed to define all customizations and configuration. Documentation was essential with this engagement.
The FDA Validation Toolkit was essential to the success of this project. The FDA Validation Toolkit was used to accelerate validation efforts. The client leveraged the validation templates and test scripts to develop their own unique test scripts based on their intended use of the system.
Results
Impacts and outcomes
The client implemented Microsoft Dynamics AX in a hosted environment and decommissioned their obsolete Mac-based desktops. The new ERP system included a new potency module that for the first time helped the client to drive more efficient manufacturing processes.
Leveraging the FDA Validation Toolkit saved the client both time and money. Time savings are estimated at 60%. The toolkit also helped the client establish business processes that were not in place to support the new GxP for Nutraceuticals regulatory requirements.
Conclusions
The Nutraceuticals industry is currently grappling with new regulatory requirements and the need to drive greater efficiency and productivity. The Microsoft Dynamics AX system was an excellent choice. Fullscope’s unique experience and FDA Validation Toolkit was essential to their success. Key success factors include: