Getting on top of the Quality Pyramid: Solutions to achieve QA/QC goals every day in a Paperless Environment
Mr. Sekhar Surabhi, CMD of Caliber Group (India & USA) of companies and is the functional architect of a leading Laboratory Information Management System, CaliberLIMS, specially designed LIMS for the regulated industries for addressing the information management challenge. He has been working with several pharmaceutical companies to help them comply with computer validation norms, especially GAMP compliance for large software applications. He specializes in managing integrity of critical applications in highly regulated global environment. Prior to founding Caliber, Sekhar, worked extensively in analytical instrumentation and pharmaceutical core testing facility. He established and managed Analytical testing facility for pharma and food testing, which was successfully audited by international audit teams. His company is recipient of several awards of excellence and he was also conferred as Entrepreneur of the Year Award from HMA. Sekhar is a Director on board of ISPE India (international Society for Pharmaceutical Engineering).
Mr. Mark Portsmouth has worked for a variety of Leading Global Pharmaceutical Research Companies including AstraZeneca (UK), Galapagos NV (Belgium) and Takeda (UK). In addition, in 2000 he co-founded CombiPure, a CRO focussed on Combinatorial Chemistry services.
Mark also has significant people management and leadership experience at senior levels which ensures rapid understanding and alignment with your corporate goals and priorities for the lab functions supported. He is a Fellow of the Royal Society of Chemistry (FRSC) and a committee member for the UK Chromatographic Society.
In the life-sciences industry, quality of product is of highest priority. After all, your products support, enrich and save lives. Hence, companies must integrate quality systems with risk management approaches and optimize quality processes to achieve QA/QC goals. Caliber’s products (CaliberLIMS, CaliberQAMS, CaliberDMS, CaliberBRM, Nichelon5) help the quality systems in life-sciences operations to achieve the targeted quality and yield. These products serve the independent quality issues of Pharma QA, QC, and Manufacturing functions. Together, these products form Caliber’s Integrated Quality Management (IQM) solutions.
In this workshop, we discuss the various methods and tools that can help you achieve your quality goals faster and maintain your highest quality.
- How to achieve Quality objectives in lesser time and effort
- How can a paperless laboratory help in quality goals?
- Collecting and using data digitally to make better decisions for product quality
Caliber is an informatics company which focuses on the enhancement of pharma operations. Over 16 years of existence, Caliber has earned the preferred vendor status amongst multiple laboratories across the world. With game-changing solutions ranging from Integrated Quality Management to Instant PQR generation to implementing the first 100% Paperless Laboratory in India, Caliber stands out as a key solution provider in the Lifesciences industry. Our vision is to make laboratories across the world to work in easier environments while maintaining the same level of integrity and commitment towards the quality of their products. With this vision, we make products which have the power to transform the way laboratories function by providing well-researched solutions which are dependable, efficient and secure.
Our products are:
- Caliber LIMS (Laboratory Information Management System)
- Caliber EBRM (Electronic Batch Records Management System)
- Caliber QAMS (Quality Assurance Management System)
- Caliber DMS (Document Management System)
- Nichelon5 CMS (Competency Management System)
Caliber’s range of products are made with the intention to effectively enhance a laboratory’s efficiency, compliance, quality, data security and much more.