MasterControl
55 Case Studies
A MasterControl Case Study
Detroit-based Ash Stevens Inc. (ASI), a leading developer and manufacturer of small‑molecule APIs, faced growing challenges maintaining GMP compliance (ICH Q7, 21 CFR, EU Annex 11) using a fragmented, hybrid system of software, spreadsheets and paper records. This made calibration, maintenance scheduling, record retrieval and reporting inefficient and increasingly difficult as the company expanded.
In 2011 ASI implemented MasterControl All Access, deploying integrated document, training, equipment calibration and maintenance modules to centralize schedules, electronic records and GMP controls. The solution streamlined retrieval and reporting, simplified calibration and maintenance workflows, and scaled to support about 80 users across nine departments and two facilities while improving overall compliance and efficiency.
Sohan Manga
IT Director and Technical Subject Matter Expert