Newsletter | November 30, 2021

11.30.21 -- Digitalizing Quality In Life Sciences

Digitalized Quality In Life Sciences: Roadmap To Sustainable Growth And Speeding Products To Market

The systems and processes life sciences companies have used to manage quality are inadequate by today's standards. Manufacturers need to adapt and implement a new strategy that aligns quality with success by design and transforms quality and quality data into a competitive asset. The forward-thinking life sciences enterprise will achieve this by digitalizing data, connecting the digitalized data to related business and operational systems, and applying analytics to identify new insights.

Timely Batch Release: Don't Let Your QC Labs Slow You Down

Sampling and test execution, data entry and review, reporting and documentation, approval, and certification — QC labs need to accomplish all these steps according to defined procedures and in compliance with regulations. It is impossible to do so efficiently without a true digital system. In this webinar, a panel of experts articulate a realistic and achievable vision for QC labs that will help increase productivity for timely batch release while improving data integrity and regulatory compliance.

Digital Lab Documentation: Improve Collaboration, Productivity, And Reduce Costs

Laboratory organizations need an environment that facilitates and optimizes collaboration, experiment execution, documentation and data management in the different labs, from R&D through manufacturing to commercialization. By implementing a digital lab solution, you can bridge the innovation and productivity gaps in research, development, manufacturing, and quality, and enable successful technology transfer across new product development and production operations.

Implementing An Integrated Quality System To Support Business Growth

A multinational pharmaceutical company with worldwide commercial operations needed to successfully meet compliance requirements for regulatory agencies worldwide, including the FDA, EMA, and ANVISA. Geographically dispersed and disconnected business units demanded virtual collaborations that were difficult to support, and many processes throughout the company were manual and disconnected, hindering productivity and collaboration. The company implemented a solution to enable them to deliver high quality, compliant products in an efficient manner.

Biopharma Accelerates Lab Digitalization With Unified Laboratory Operations Management Solution

Growing complexity and diversity of expanding product lines and the acceleration of clinical trial processes had put a company’s chemistry, manufacturing, and controls (CMC) organization on the critical path for commercial product launches. By implementing a common solution across all CMC labs and for all therapeutic modalities — both small molecules and biologics — they established a common platform for use across all drug substance, drug product, and analytical development labs worldwide.