Reduced compliance time for FDA regulated businesses
If you’re a life science organisation such as a medical device manufacturer or pharmaceutical company, you need to control a high magnitude of operating procedures and documents. Massive documentation is required to comply with FDA regulations (21 CFR Part 820 and Part 11) regarding processes, controls, activities, changes, histories, non-conformance and resolution. Typically, these interdependent controls and documents are scattered across operations and systems. The result is that you can lose critical time, with FDA warnings and recalls becoming common and miscommunications becoming the norm. However, by using IFS’ fully integrated applications and lifecycle management, you can eliminate these problems.
Faster time to market with all processes supported in one solution
By using a common information platform that captures data, events and electronic signatures in one place, you can gain greater control and compliance across every business process and product lifecycle. This significantly reduces your time to market and your costs. IFS’ life sciences solution is one of the only solutions that provides this common platform and offers comprehensive support for mixed-mode manufacturing, including make-to-order and the traditional shop order/production scheduling. Additionally, IFS provides advanced configuration handling with serial-number control. For product definition, you can mix configured and normal bills of materials. Also, lot/batch-tracking ensures that you can trace the manufacturing process for a product after it has been sold. In a process environment, maintenance is essential, and a trimmed production line not only is more productive, but also produces better quality at a lower cost. In IFS Applications, maintenance can be made a function of production and planned periodically, by usage and/or reported quality.
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