The life science segment is one of the oldest at Novotek and has always been one of our largest segments. Novotek has provided solutions for all major companies in this segment including Pfizer, Astrazeneca, Merck, Johnson&Johnson and Novo Nordisk. We do complete “turn-key” solutions with or without validation requirements.
Our solutions in life sciences
The products we have in our solutions, in life sciences, are to all major extent, CFR21 Part 11 certified with modules for audit trail, security and reporting tools. We see this as very important in order to secure the future upgradeability without jeopardizing the validation.
Our ISO certified QA system has been audited several times by pharmaceutical companies with great results. We are proud to be able to deliver complete projects based mainly on standard components.
How we solve your challenges in life sciences
As conditions in both production environments and health care delivery markets become tougher, it’s increasingly important to focus on production operations as a source of competitive advantage. With a suite of solutions designed to yield deep insight into how ingredients and equipment interact, Proficy provides an ideal platform to address needs ranging from basic batch execution and control through process analytics, to work process management in support of CAPA regimens.
Get insight into product flow by tracking production against specifications, equipment and schedules. Get access to detailed tracking data for comprehensive by-batch or long-term, analysis and visualisation.
Proficy Plant Applications Production is a powerful software module that provides the end-to-end visibility into your process and products that you need. Part of the larger Proficy Plant Applications Collaborative Production Management suite, Production provides access to the information you need about source, quality, and personnel – from the raw materials to the finished tablet.
Whether you’re performing statistical process control or process capability analysis, generating control charts or performing an annual product review, Plant Applications Quality gives you the data access and tools you need.
Plant Applications Quality tracks and monitors your product and process quality in real time using data collected from all sources – manual and automatic. Reason codes, process values, research notes as well as recipe, batch, lot and materials information all are captured and analysed to identify root cause problems. Alarms are exposed at data entry and data acquisition time, and it even has electronic signature capabilities.
The Food and Drug Administration in early 2000, began looking at ways to help companies improve their manufacturing processes while remaining in compliance with regulations. The result was two guidance documents: PAT and cGMPs for the 21st Century.
Companies such as McNeil, part of Pfizer, choses Proficy to increase OEE of its packaging lines. This helped it to identify and improve areas that were causing
operational inefficiencies. It allowed analyses of root causes to make data-driven decisions. As a result, it manages operations in realtime through comprehensive
reporting, which can be made accessible via the web.