503A / 503B Compound Pharmacy
Lean Validation For Microsoft Dynamics
Lean Validation For Microsoft Dynamics AX 2012®
The Compound Pharmacy company is a recognized leader in providing IDPN and IPN therapies for dialysis patients, as well as providing specialized in-home care for patients with implanted intrathecal pumps delivering medicine to treat severe spasticity and intractable acute or chronic pain. The company was seeking to implement and deploy a corporate-wide ERP system to manage its full supply chain operations. The system must comply with the technical and procedural controls for 21 CFR Part 11. As a compound pharmacy company, the firm did not have Standard Operating Procedures (SOPs) in place that provided governance for their validation processes. They required assistance in developing lean validation processes to support the business.
The objectives for this compound pharmacy were:
- Implement, deploy and validate a technical platform for 503A and 503B business operations
- Deliver a robust solution for the compound pharmacy that delivers the highest levels of corporate controls, security, good business practices and audit transparency.
- Implement an integrated ERP system managing the full lifecycle of the supply chain including financial management and accounting, inventory, warehouse, management, and production.
- Validate the system in accordance with U.S. FDA and ISPE GAMP 5® guidelines.
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onshore professional services
Methodology and approach
The company leveraged our ValidationPro℠ turnkey professional services. We brought a team of experienced, qualified validation engineers to the OnShore Technology Group conducted a Validation Workshop at the beginning of the engagement to understand the gaps/deficiencies in their validation process. We worked with internal stakeholders to develop a comprehensive set of SOPs that provided governance for validation. The SOPs included document templates to facilitate the easy completion during the validation process. OnShore worked directly with the System Integrator responsible for the implementation and deployment of the Microsoft Dynamics AX 2012 system to ensure that all requirements beyond the COTS requirements were captured. The client leveraged the COTS user requirements specification provided with the Validation Accelerator. They added their unique requirements to complete this document. The company also leveraged over 120 IQ/OQ/PQ test scripts provided by the Accelerator and developed custom scripts to represent the difference between what was delivered through the Accelerator and those unique scripts required. OnShore prepared all validation document deliverables with oversight by the client. We also executed all test scripts in accordance with U.S. FDA and ISPE GAMP 5® guidelines. Validation of the ERP was conducted in two distinct phases including Phase (1) Finance and Phase (2) supply chain operations.
Impacts and outcomes
The company successfully executed Phase I and Phase II validation for this initiative. OnShore Technology Group developed a full set of SOPs to provide governance for all future computer systems validation projects for the compound pharmacy. The company also developed a reusable test script library to support regression testing of Microsoft Dynamics AX 2012® environment henceforth. The company leveraged our lean validation methodology to streamline the validation process and optimize testing.