New laboratory information management solution from Applied Biosystems brings efficiency and cost effectiveness to drug development and manufacturing process

Applied Biosystems has announced a new laboratory information management system (LIMS) that is expected to help pharmaceutical companies maintain regulatory compliance and decrease the cost of managing their manufacturing operations. The SQL*LIMS® Plug and Play Pharma Package™ solution is a pre-configured and validated LIMS developed specifically for the pharmaceutical industry that has been shown to reduce up to 85 per cent of the cost and as much as 75 per cent of the time associated with deployment.

Software-based LIMS solutions are used by pharmaceutical companies to manage their drug development and manufacturing processes. This includes tracking raw materials and samples as they enter and travel the laboratory workflow. Maintaining best practices and consistency in these operations are necessary for complying with regulatory requirements and ensuring a safe and reliable supply of pharmaceutical products.

The deployment and validation of LIMS software has traditionally been expensive and time consuming. The validation process alone requires that a company audit the LIMS to demonstrate that it adheres to specific national and international regulations such as operational procedures, security definitions, and testing methods. As a result, considerable time and expense are often spent in designing, customising and validating traditional LIMS, which can significantly increase the total cost of the overall solution.

Analysis conducted by Applied Biosystems indicates that a typical LIMS implementation takes approximately eight months, with most of that time spent configuring and validating the system. Because SQL*LIMS Plug and Play Pharma Package is specifically designed and validated for the pharmaceutical manufacturing industry, Applied Biosystems’ customers have been able to implement the system in as little as two months.

Kern Pharma, SL, a pharmaceutical development and manufacturing company based in Spain is one of the first organisations to implement the SQL*LIMS Plug and Play Pharma Package. This particular pharmaceutical company was attracted to the solution’s out-of-the-box functionality that allows it to be implemented with minimal reallocation of human resources away from their primary manufacturing responsibilities.

“What makes SQL*LIMS Plug and Play Pharma Package unique is that it arrives ready to deploy, with the operational functionality required for managing the pharmaceutical manufacturing process,” said Albert Almajano, IT project manager at Kern Pharma. “We expect that SQL*LIMS Plug and Play Pharma Package will become an integral part of our ongoing efforts to improve efficiency and maintain regulatory compliance in our drug development and manufacturing operations.”

Applied Biosystems designed SQL*LIMS Plug and Play Pharma Package as a complete solution that integrates critical functions involved in drug manufacturing operations with the computer hardware and an Oracle database that enables distribution across an enterprise. The pre-configured functionality enables system administrators to easily activate user definitions, security parameters, reporting templates and testing methods issued by national and international regulatory bodies. This can help pharmaceutical companies who are upgrading their existing LIMS as well as those who are new to manufacturing to quickly implement a validated system that incorporates industry best practices and meets regulatory requirements.

“Pharmaceutical companies are too often spending excessive time and money on building and implementing business solutions that require skill sets or other cost-related resources that take away from their core business purpose,” said John Bainbridge, general manager for the LIMS business at Applied Biosystems. “To help these customers, we’ve taken everything Applied Biosystems has learned about laboratory information management systems and have packaged it into a complete solution that significantly decreases the time and costs associated with LIMS deployments. This enables pharmaceutical companies to focus on what they do best, which is developing and manufacturing drugs."