Lab of the Future: Manifesto: digital technology-based capabilities for the quality control (QC) lab of the future

Quality control (QC) labs have not been enhanced with the digital enablement that is deployed in the manufacturing environment:

• In most cases, test execution is not automated, partly because a lot of lab equipment cannot yet be controlled digitally.
• Technicians use many non-integrated systems with poor user interfaces; they are not guided or assisted by technology which could reduce repetitive tasks and help to further reduce human error levels in both process and data.
• Data are not captured or shared automatically or consistently, making it very difficult to use analytics to optimize outcomes and ensure the integrity of analytical data as required by regulatory agencies.
• Technology advancements for at-line and in-line approaches are not yet well supported and could help more closely integrate QC into the manufacturing process.

Purpose of document and action plan

• Articulate a necessary, realistic and achievable vision of the QC lab of the future shared by leading biomanufacturers and inspired by Biophorum’s digital plant maturity model.
• Stimulate collaboration between biomanufacturers and vendors of lab equipment and software.
• Help laboratories and vendors of lab equipment and software construct roadmaps.

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Manifesto Digital technology-based capabilities for the quality control (QC) lab of the future July 2020.pdf
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