Sweden's Recip AB has signed a deal that will see it implement a suite of cGxP software modules that will provide real-time management of production line operator work instructions, electronic batch records, equipment tracking and calibration, and personnel training records.
The Regulus software, developed by Decision Management International of the USA, is already in use by many of the world's pharmaceutical, biotechnology and medical device companies.
Recip, which markets its own proprietary brands and undertakes contract packing and manufacturing, said that it was making the investment as part of a strategy to become the dominant packaging and finishing services provider to the European pharmaceutical market, a business it operates under the Recipharm banner.
The Regulus software applications will be deployed in Recip's new 14 line, fully-automated packaging facility to assist the production operations with reducing product cycle time, as well as the cost and labour burden associated with regulatory compliance data collection and reporting. A Scottish company, Process Knowledge Systems, has also been contracted to provide the services for the software configuration, systems integration and validation during the implementation of the modules over the next nine months.
Thomas Eldered, executive vice president for Recip, said that the firm "has experienced a significant growth of its business during the last several months and, as a result, must address increased production and quality control demands associated with the business volume increase". He added that the Regulus package provided an 'off the shelf' package for electronic record, signature and audit trail controls "without taking 2 years to complete installation and validation".
The system will allow Recip AB to automate many of its manual paper processes and improve product cycle time to market, said Wilhelm Tottie, Recip's chief information officer.