The Challenge
In the tightly regulated pharmaceutical industry, Actavis realised that it needed to replace its outdated Document Control System to satisfy new regulations and to adhere to current Good Automated Manufacturing Practice (GAMP) guidelines. It wanted a reliable, easy to use system that could be adapted to changing needs. Security of the application is paramount and in the manufacture of its generic medicines, Actavis needs to ensure that only approved medicine recipes are used and that a record of the person responsible for each production run is maintained.
The Solution
Recognising that its unique needs could not be satisfied by an off-the-shelf product, Actavis began the search for a company, which could develop a solution to match its exact requirements. Based on a long-standing and successful relationship Actavis selected Dorset Software to develop a bespoke solution. Building upon the functionality of the current Document Control System, Dorset Software worked very closely with Actavis to understand: the issues with the current system, user and management requirements; the regulations concerning pharmaceutical manufacture and Actavis' IT infrastructure.
The solution developed and delivered by Dorset Software was a Batch Manufacturing Record Control System that worked within Actavis' MS Windows operating environment and that would ensure continued compliance with the strict regulation of providing an audit trail. Dorset Software succeeded in delivering the easy to-use Batch Manufacturing Record Control System to Actavis' exact specification, on time and to budget.
The Benefits
The Batch Manufacturing Record Control System is a robust and reliable system that allows Actavis to maintain compliance with the strict regulations of pharmaceutical manufacture. With four levels of access, user security is vastly improved enabling control and transparency of activity. Developed using industry standard tools, the BMR system holds documents securely and controls their issue and printing. The intuitive application has also dramatically reduced the time required to make changes to batch manufacturing records.
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