LIMS is the acronym for Laboratory Information Management System. It is a software tool to record, process and manage the huge amount of information that is created (master data) or generated (transactional data) in a laboratory. The enormity and complexity of the data accumulatedin a laboratory will be too much to be handled faultlessly by unaided human operators or technicians. Hence this software mantra known as LIMS.
Why LIMS
Consistent quality and dependability are what build the reputation and acceptability of a product or material. The product or material quality is vital to a company's credibility. Quality must be both manifest and demonstrable to attract, reassure and retain the users and the intermediaries. Companies need to maintain in-house Quality Control laboratories or outsource professional and reliable laboratories. Quality Control is a continuous process involving complex tasks of tests, certificates and reports. Quality Control tasks, especially in food and pharmaceutical industries, are getting more and more complex and time sensitive. Quality system norms and statutory requirements are getting more and more stringent. Data recording, data processing, certification, etc. must be error free and tamperproof. Data security and authenticity must be ensured at all costs. Pure human effort and manual work are no longer sufficient to manage enormous information and maintain authentic quality standards.
It is in this area that a good LIMS will become an invaluable asset to automate the entire dataflow in lab operations in a secure manner and to save costs by optimizing human as well as infrastructure assets. LIMS is seen as the greatest tool for the lab automation and compliance with the regulatory requirements of GLP, GMP, and FDA etc. Nevertheless Payback Value or Return on Investment on LIMS is one of the strong driving factors for the LIMS implementation decisions. Caliber LIMS is one such product with additional feature sat affordable cost.
Caliber is the short name for Caliber Technologies Pvt. Ltd. It is a software company belonging to Caliber Group. For over two years Caliber Technologies has been engaged in the development of Caliber LIMS and its augmentation. Its first product Caliber LIMS1.0 has been in use at Dr Reddy's Laboratories for over 18 months. Caliber Technologies continued its focus on Laboratory Information Management System (LIMS) and other software aids for pharmaceutical companies and laboratories. It has already developed a mature and value-added version of web-technology based 21 CFR Part 11 compliant LIMS. The product Caliber LIMS 2.0 is already in use /under implementation at multiple locations in leading pharmaceutical companies in India namely Dr Reddy's and Aurobindo Pharma. Caliber LIMS 2.0 has been successfully integrated with the existing SAP system at Dr Reddy's.
Caliber Technologies has also developed a specialized 'Petro' version of Caliber LIMS. It has also developed other laboratory aids like a stand-alone system for Controlled Label Printing called Caliber CLAPS, and another system for Job and Instrument Scheduling called Caliber SKEDS.
Caliber Technologies is about to open its subsidiary in USA, for marketing its LIMS and other products in USA and Europe. It is also entering into a strategic alliance with an internationally reputed Indian software company, to implement Caliber LIMS for Pharmaceutical and Petroleum Companies in India and the Middle East. Caliber LIMS is one such product with exclusive additional features. It is a thoughtfully developed, well structured and Web Technology based Lab Information Management System package. It is especially devised for profitable deployment in Pharmaceutical and Biotech industries and Institutional Laboratories, complying with international quality system standards and Good Laboratory Practices (GLP). It conforms to US FDA's 21 CFR Part 11: Electronic Records: Electronic Signatures. Caliber LIMS is fully validatable, with the help of Protocols specially designed for easy and speedy completion Installation Qualification, Operational Qualification and Performance Qualification tasks. Caliber Technologies will get involved with the customization task right from the Requirement Gathering to Feature Development, Installation, Operation and Performance Qualification documentation and implementation of the accepted/augmented version of Caliber LIMS.
Caliber will provide all the validation documents for: Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ). Trained personnel form Caliber can assist in executing the qualification protocols.
With Caliber LIMS, its nominal customization and quick learning result in fast returns on investment. It drastically reduces human errors and ill effects of human inertia, fatigue and tendencyto procrastinate, thereby increasing staff efficiency, lab productivity and profitability. Adherence to Quality System Norms and compliance to 21 CFR Part 11 norms will be automatic. Changes will be authentic with electronic signatures and tracked by audit trails. The data will be authentic and secure. It provides minute-to-minute sample status, MIS Reports and trend charts. It helps in management of Instruments, calibration, consumables, and other resources. It can even be configured for direct connectivity to lab instruments. All records being electronic, it saves storage space for ledgers, registers, etc. The gains are many, and recurring.
Caliber LIMS is an indigenous product created by Indian engineers it is especially suitable for Indian laboratory conditions and practices. It has been enriched with various value additions and add-on modules to make it one of the most comprehensive and user-friendly LIMS currently available in its price range.
Unlike expensive imported LIMS brands, Caliber LIMS is currently available to Indian customers in Indian Rupees. The cost of its implementation and customization is very affordable even for multiple users at multiple locations of an organization. The delivery is almost off the shelf and the customization will be nominal. The maintenance and support will be prompt and affordable. Updates and upgrades as and when released will be readily made available.
-- The author is director, Caliber Technologies Pvt Ltd