Innovative West Coast Biotechnology Company

Microsoft Dynamics 365 IV&V

Case Study

Microsoft Dynamics 365 IV&V Corporate Initiative

United States, Switzerland

Biotechnology

The client engaged OnShore as the IV&V service provider to lead the validation effort for Microsoft Dynamics 365 For Finance and Operations initiative.  The goal of the project was to implement and validate an integrated supply chain system.  The company also implemented several other technologies including MES, LMS, Quality Document Management, Learning and Competency Management, LIMS, CMMS, and BAS/EM.  The company required assistance with procedures and work instructions to support the validation process and was seeking to accelerate the validation of Dynamics 365.

The objectives of this project was to implement core financials and supply chain management modules including inventory, product management, BOMs, costing, and direct purchasing.   The company also implemented Merit MAXLife as part of this initiative.  Another objective of this initiative was to establish a system in compliance with 21 CFR Part 11.

Purchase CloudMaster 365℠ Validation Accelerator and/or ValidationMaster Enterprise Validation Management system

yes
yes

onshore professional services

validationPro-multicolor

Methodology and approach

The company divided the initiative into two distinct phases.  The first phase was to implement the finance functionality and conduct installation qualification (IQ) of the system.  No GxP functionality was implemented in the first phase.  During the second phase of the project, the company implemented all GxP-related supply chain functionality and deployed all integrations.  The validation strategy was to leverage ValidationPro professional services to provide end-to-end validation project support.  We managed all aspects of the validation project from the development of validation planning documentation, user requirements development, 21 CFR Part 11/EU Annex Assessment, and a system risk assessment.  We leveraged the CloudMaster 365℠ Validation Accelerator and our lean validation methodology to jump start validation testing.  Given Microsoft’s new cadence strategy, the client wanted to accelerate the validation of the system.  CloudMaster 365℠ delivered a full set of validation documentation including user requirements, IQ, OQ, and PQ test scripts pre-loaded into the ValidationMaster™ Enterprise Validation Management system.  The requirements were linked to their respective test scripts such that upon commissioning of the production environment, the client had the ability to complete the validation planning documents provided with the system and conduct validation exercises on the COTS functionality.  When changes are made to the environment as Microsoft updates their system functionality, the client is able to reuse the existing test scripts and easily confirm the impact of changes on the existing features.

Results

Impacts and outcomes

It should be noted that OnShore Technology Group has been developing “Validation Toolkits” and Validation Accelerators for Microsoft Dynamics AX/GP/NAV for over 15 years.  Since the launch of Dynamics 365, OnShore Technology Group developed a unique, comprehensive validation accelerator exclusively for Microsoft Dynamics 365 to help aid in the validation of this ERP solution.

Conclusions

The Biotech gained many benefits from the system.  The CloudMaster 365℠ solution that delivered a full set of validation documentation including user requirements, IQ, OQ, and PQ test scripts pre-loaded into the ValidationMaster™ Enterprise Validation Management system was a game-changer.  The company was able to leverage a complete set of validation planning documents pre-written to support Microsoft Dynamics 365 including the Validation Master Plan, Validation Determination Statement, Risk Assessment, 21 CFR Part 11 Assessment and many others that could be completed in hours rather than weeks of development from scratch.  They were able to fully leverage the out-of-the-box test scripts and user requirements for COTS functionality quickly and easily.  The company was able to validate their system on-time and within budget.

Leveraged 100+ reusable validation test scripts

Able to export all pre-developed validation documentation quickly and easily into the clients’ validation document format

Conducted a Cybersecurity Qualification (CyQ) for the cloud-based ERP

Established a single source of truth for all validation projects within the company. ValidationMaster, which is delivered as part of the CloudMaster 365℠ solution, may be used FOR ANY software application – not just for Microsoft Dynamics 365

Accelerated validation planning efforts leveraging pre-written documentation to support the validation of Microsoft Dynamics 365

Established a reusable test script library for Microsoft Dynamics 365

Eliminated the need to rewrite COTS validation test scripts saving the company significant time/money in the development of these scripts and allowed them to focus only on the development of test cases that were unique to their company

Company established Lean Validation processes and governance for their validation program