Global West Coast Medical Device Manufacturer
Microsoft Dynamics AX 2012
Integrated Microsoft Dynamics AX 2009 IV&V Project
US, UK, South Africa, Japan
The global medical device manufacturer develops and produces medical devices and systems subject to strict FDA regulatory guidelines including 21 CFR 820.30, 21 CFR Part 11, 21 CFR 210/211 (cGMP). 21 CFR 820.30 is the Quality Systems Regulation for Design Controls that requires medical device manufacturers to establish and maintain a Device History Record (DHR). The regulations required this device manufacturer to establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and FDA guidelines. The focus of the project was to implement a new ERP system based on Microsoft Dynamics AX to support DHR requirements as well as global supply chain requirements. The client was using a legacy non-integrated ERP system.
The business objectives for this initiative were as follows:
- Enable Business Growth With Scalable, Adaptable Systems And Tools
- Improve Timeliness And Quality Of Decision Making Through Faster, More Automated And More Accurate Performance Reporting.
- Standardize And Optimize Processes And Systems Across The Company
- Lower Operating Costs
- Ensure Compliance And Business Continuity
Due to the regulatory impact of the data housed within the ERP system, OnShore was engaged to deliver a qualified validation team to validate the system in accordance with global regulatory guidelines.
Purchase Toolkit and/or Automated Validation Software Tool
onshore professional services
Methodology and approach
ValidationPro℠ is a turnkey IV&V service offering designed to deliver a qualified team of validation engineers to perform end-to-end validation services. Our engagement began with our 5-day Validation Workshop. The workshop is designed to establish common ground with the client and to review their validation readiness. During the workshop, we discovered that the client did not have adequate SOPs that provide governance for validation. As a good set of SOPs are the starting point for validation, we assisted the client in getting their procedures in place prior to conducting any validation work. We followed the ISPE GAMP 5 methodology and through our accelerator, provided them with the validation document deliverables required to validate the system. OnShore prepared all validation documentation, updated test cases and risk assessments to support validation. For this project, we leveraged an automated test preparation tool to generate test scripts quickly and efficiently. We developed over 550 test scripts which encompassed testing for COTS functionality as well as over 300+ customizations and 8 third party integrations including Field Service Management, BI360, interface with Agile PLM, Salesforce.com, ClippersShip, EDI, Label Control, MES and barcoding.
Impacts and outcomes
OnShore Technology Group delivered a team of qualified validation engineers and project managers to prepare validation deliverables and execute all test cases to support the initiative. Using automating testing, we were able to reduce the test script development time from 1.5 hrs to about 10 – 15 mins per script. We were also able to automate traceability throughout the project. The project resulted in an improved methodology for the client and a fully validated system with processes in place to help maintain the validated state.