GAMP5 complience in pharma industry.

The pharmaceutical industry is subject to strict regulatory requirements which demand a lot of time and effort to be spent documenting every step, process, and item. Itris Automation will be hosting a webinar in March 2017 to demonstrate how PLC Checker can help pharmaceutical companies more efficiently verify and document the GAMP 5 compliance of their PLC programs.

Part of the International Society for Pharmaceutical Engineering (ISPE), Good Automated Manufacturing Practice (GAMP) is a set of guidelines regarding automated systems. These guidelines explain how to incorporate quality into each step of the manufacturing process to achieve the required quality of the finished product. Although not an obligation, most pharmaceutical companies choose to be compliant with GAMP, now recognised worldwide as a good practice. However, ensuring compliance and creating all of the required documentation is a laborious process.

In the webinar, you will discover an innovative way to address Appendix D4, “Management, Development, and Review of Software”, of the GAMP guidelines which will save companies time and money. Using PLC Checker, a unique static analysis tool dedicated to PLC programs, and the GAMP coding rules option, users can quickly and efficiently verify their level of compliance and automatically produce the necessary documentation.

Join the webinar to find out how you can save time and money in your GAMP 5 compliance process.

Karoline Beske, Export Director at Itris Automation, will conduct the first webinar in English on 20th March at 4pm (GMT+1) and a second in German on 27th March at 11am (GMT+1). Both webinars are free of charge and open to anyone. Book here.

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