Industries that are subject to strict regulations, such as the pharmaceutical and life sciences sectors, often encounter the same problem: project validation usually takes twice as long and uses double the resources when compared to the engineering phase itself. A large portion of the costs stem not from the project but from the validation. And the same applies for every single change. Thanks to zenon, things are changing.
- Save time and money during the validation phase
- Shorter setup times
- Minimize risks by eliminating sources of error
- Out-of-the-box: GAMP 5 software category 4 and FDA 21 Part 11
When it comes to programmed applications, validation often takes twice as long as the engineering itself. When you use a category 4 GAMP 5 software instead, validation is reduced to just half the time needed for engineering.
Speedier engineering, speedier validation
zenon meets the ISPE GAMP 5 Guidelines for software category 4. In practice, that means significantly speedier system validation. What’s more, zenon also meets the requirements of GMP (Good Manufacturing Practice) and FDA 21 Part 11 for strictly validated production environments, such as the pharmaceutical industry.
In zenon, projects don’t require extensive programming. Instead, pre-prepared components are on hand to support engineers for quick, error-free results. zenon also comes with templates for various screens to allow for speedy implementation. The reduction in engineering work and the accelerated validation process for projects keep project engineering phases short while ensuring speedy setups.
Complex functions out-of-the-box
zenon allows for quick and efficient validation by providing complex functions and key components straight out-of-the-box. Extensive reports (Audit-Trail, alarm statistics, etc.) are created at the touch of a button. Templates for Alarm Message Lists or redundant systems and complex network architecture are configured in a matter of minutes without any tedious programming. The comprehensive user administration function – including Active Directory integration – provides your system with the security it deserves and is also available out-of-the-box.
If you were to program all of these functions, you would have to validate every single line of code. And every time you changed the code, you would have to validate it all over again. zenon’s out-of-the-box functions only need to be validated once and then can be used again at any time without any revalidation being required.