Integration optimises pharmaceutical manufacturing and QA/QC workflow by providing an online link between quality management systems, hromatographic data systems, and analytical devices
Agilent Technologies and Bayer Business Services will develop and market the integration of BBS's Covin instruments logistics solution and Agilent's networked data systems, including Agilent Cerity NDS for pharmaceutical quality assurance/quality control (QA/QC) and Agilent ChemStation.
The integration optimises the pharmaceutical manufacturing and QA/QC workflow by providing an online link between the SAP R/3 quality management systems, chromatographic data systems and analytical devices. Users can now transfer information between the different systems directly instead of manually re-entering data.
This agreement is expected to benefit analytical laboratories in a wide range of industries, specifically those that must comply with GxP, FDA 21 CFR Part 11 and related regulations.
The integration of the two companies' solutions is facilitated by the open-systems architecture of Agilent's networked data systems, which can seamlessly integrate with enterprise IT infrastructures. BBS's Covin instruments bridge the gap between the mySAP product lifecycle management quality management (PLM QM) solution and the laboratory instrumentation level.
Covin instruments eliminates the need for a separate laboratory information and management system (Lims) by enabling mySAP PLM QM to provide full Lims functionality.
Using an SAP-certified interface to QM-IDI, Covin instruments is designed to provide a work list of inspections to a client, depending on analytical method and instrumentation requirements.
Raw quality-inspection data is collected from a wide range of instruments, managed, and archived in compliance with FDA 21 CFR Part 11 and ISO quality standards. After optional validation, measured and calculated end results are sent back to mySAP PLM QM to trigger subsequent actions in the logistic chain.
Agilent Cerity NDS for pharmaceutical QA/QC is designed to meet the specific requirements of QA/QC labs in the pharmaceutical industry.
It provides centralised management of chromatography data for labs from one instrument to several hundred instruments and many users.
It reduces a lab's operating and validation costs by accommodating the laboratory's workflow and by facilitating compliance with FDA 21 CFR Part 11 and quality standards.
Agilent ChemStation is a family of networked data systems that provides modular software components for instrument control, data acquisition and data management, with the flexibility to meet both a lab's present and future requirements.
The ChemStation base software handles applications such as liquid chromatography, liquid chromatography/mass spectrometry, gas chromatography, capillary electrophoresis, and capillary electrophoresis/mass spectrometry. It can be extended with add-on software modules for data organisation and storage, remote control and monitoring, compliance with regulatory guidelines (21 CFR Part 11), and validation of analytical methods.
