Interface between QBDC TEMIS cGMP compliant DMS system and Exputec inCyght bioprocess software
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EXPUTEC GmbH and QBDC GmbH have agreed to form a mutually beneficial business partnership to cooperate in the field of bioprocess organization and GMP compliant document and data management.
By September 2018, inCyght bioprocess software by Exputec will have a certified interface to TEMIS cGMP compliant document management software by QBDC.
“With Exputec’s powerful data management software and our GMP document management system, we are able to provide an integrated solution for pharma and biotech companies.” explains Dr Landauer, Managing Director of QBDC.
The ‘marriage’ of these two systems shall enable efficient tracking of R&D and GMP information and provide company-wide access to data in a regulatory compliant manner. Many companies fear the immense effort and the high costs required to maintain control over digital information, and, thus, often resort to fully paper based GMP documentation.
With this cooperation, both Exputec and QBDC aim to fill a major gap in the industry, which shall bridge a way past due towards a paperless 21
Exputec GmbH is one of the world’s leading software providers for the organization of bioprocesses within companies and across company boundaries. Their software solution inCyght is used in pharmaceutical and industrial biotechnology, and specifically for:
- the organization of bioprocess data across bioprocess development, tech transfers and operations.
- the cooperation with CMOs and CROs, for USP, DSP, quality, MS&T operations.
- the organization of data analytics workflows for various stages of the bioprocess lifecycle, such as: scale down model qualification, process validation and characterization, process development workflows, stability trending, continued process verification
Customers of inCyght bioprocess software include Boehringer Ingelheim, Wacker, Bayer, Evonik, Horizon, Nektar, JHL, Rentschler and others.
QBDC GmbH is a Switzerland-based, internationally active biopharma consultancy company with the focus on interface management. They present themselves as experts in building “bridges”, which facilitate the passage across technological, and cultural gaps, and they provide aide in constructing strong and sturdy GMP foundations.
Their vast experience in various biotech topics allows them to help their customers recognizing and addressing risks before they become severe, help them being prepared for looming challenges, and help them optimizing their workflows to reduce time and costs.
QBDC provides consultancy for:
- CMC topics (biosimilars, ATMPs, NBEs, various cell lines, media engineering, cell culture design/optimization);
- Scale-up and tech transfer (“translate” processes to larger scale/to 3rd parties both as sender and receiver, understand specific needs based on applicable technical and regulatory requirements, incorporate impact of differing cultural factors between the involved parties);
- Facility layout and design (qualify existing facilities, design and layout from scratch, COGS calculations, risk assessment, HR planning);
- QC & QA (achieve GMP compliance, compare differences in locally applicable regulations, Q-system optimization or establishment); and
- Project management (assistance in transitional phases, create development plans, define milestones, assess third party CROs/CMOs/CDMOs)
Their involvement with the everyday challenges of their customers made them recognize a significant gap in digitalization efforts. For small and medium-sized enterprises, there are no affordable, yet regulatory compliant means to track, manage, and evaluate digital data and documents, which gives them a major competitive disadvantage towards big companies. They are either forced to work with insufficient, non-compliant solutions or resort to paper-based systems. Hence, QBDC has developed two software solutions to offset this disadvantage: the above-mentioned TEMIS for cGMP compliant document management, and METIS for tracking and evaluating experimental data in laboratory environments.
QBDC Press Release, 18-03, 28.06.2018, Nusshof, Switzerland
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