Companies are developing new products faster while facing fierce competition, stringent regulations, increasing costs and mountains of laboratory data. To meet these challenges, today’s R&D and manufacturing operations demand an integrated and accessible laboratory information management system (LIMS).

A LIMS is an essential application for a laboratory’s information management infrastructure, to assure data quality and the efficient management of laboratory workflows. LIMS solutions must be flexible, configurable and open, while ensuring security and complying with government and corporate standards and/or regulations. SQL*LIMS Software from Applied Biosystems provides these capabilities for over 40,000 users in QA/QC manufacturing operations.

Prevalidated LIMS

Pharmaceutical companies spend significant time and expense planning, designing, customising and validating (IQ/OQ/PQ) their LIMS projects. For many traditional LIMS customers, the cost of validation can exceed the cost of the software itself.

Only a few years ago, virtually every pharma company had a wide variety of laboratory processes, and their laboratory personnel held tightly to the concept that their own process was ‘unique’. Today, it is widely accepted that most workflows in pharma QC laboratories are almost identical, and these common processes have emerged as Industry Best Practices. So what about having the LIMS vendor perform the bulk of the validation in a way that is reusable and of a high standard of quality based on these industry standards? Using a preconfigured, prevalidated LIMS will result in cost and time savings of up to 85%. Benefits include:

  • Project time reduced by an average of 12 months.
  • Projects are live and validated within 90 days.
  • Fully executed validation documents are provided.
  • Provision of LIMS SOPs and training modules.
  • Minimum use of staff during set-up.
  • Predictable ongoing cost of ownership.

Quality management

Quality management and deviation tracking can be a hit-or-miss proposition in laboratories where many paper-based or ‘homegrown’ systems are in use. SQL*LIMS QEMS provides quality management for all laboratory and QA/QC deviation tracking, OOS, CAPA investigations, data analysis and quality improvement programmes. Benefits of this quality event management system include:

  • Tracking progress towards closing laboratory events.
  • Provision of turnaround time guarantees to production.
  • Visibility of quality events to management through dashboards and subscriptions.
  • Visual indicators of deviations and open cases.
  • Visual stability study deviations.
  • Safeguarding releasing lots before closure of events.
  • Uploading significant events to the corporate CAPA system.

Award-winning system

Applied Biosystems was awarded the 2008 Frost and Sullivan Award for the Vertical Market Penetration Leadership in the European LIMS market for its success in the European market. The award was made in recognition of the SQL* LIMS solution, which can be successfully deployed across several vertical markets.

"The company’s ability to understand the data management needs for various industries has facilitated the development of a feature-rich and broad-scalable product," says Prabakar Sampath, head analyst, Healthcare, Frost & Sullivan. "The ability of Applied Biosystems to develop a versatile product, SQL* LIMS, capable of being deployed across several industries reducing implementation time and cost has enabled them to continue to excel in the LIMS industry."