Arbour Group
10 Case Studies
A Arbour Group Case Study
Infant Formula Manufacturing And Research, a newly independent division of a Fortune 100 pharmaceutical company, needed to replace its legacy corporate ERP system after divestiture. With a strict regulatory environment for infant nutritional products and a tight five-month implementation deadline, the company needed help validating a new enterprise software package for manufacturing, distribution, and financial operations. Arbour Group provided software testing, validation, and verification services to support the project.
Arbour Group worked with senior management and project leaders to validate the ERP system before production go-live, following the full implementation lifecycle from project preparation through final preparation. The engagement included key validation deliverables such as validation planning, user requirements, functional specifications, IQ/OQ/PQ protocols, a trace matrix, and a validation summary report. As a result, the ERP system was successfully validated and deployed on schedule within the required five months, helping ensure compliance with FDA regulations, including Part 11 electronic records and signatures.
Infant Formula Manufacturing And Research