Innovatum Knows Validation!
When a company has served life sciences giants for over two decades, validation become part of ones DNA. Making all of the validation documentation information about our products available to our customers proves helpful time and time again. And keeping customers current with new scripting that results from updates and enhancements to our software is a standard part of our software maintenance program. But many times, our customers need validation help from their side. And we are glad to step in as needed.
Innovatum is a validation service provider to several FDA-regulated companies and as a consequence we are constantly honing and updating our processes and capabilities. We follow GAMP5 protocols and adhere to risk based testing processes for both our customers and for internal development.
Validation is a significant effort associated with implementing any new system in FDA regulated industries. Given Innovatum’s background in these markets, we have taken a number of steps to reduce this burden. Due to our strict development methodologies and appropriate documentation, Innovatum has been the subject of multiple vendor audits with excellent results. Thus, we welcome customer inspections.
In addition, Innovatum offers a comprehensive Validation Documentation Packet for ROBAR, including: URS/FRS, Functionality Matrix, IQ, OQ and test scripts for every function of the system. Consequently, users do not have to create a validation plan from scratch, which can save hundreds of staff hours and accelerate implementation and go-live dramatically. Moreover, the ROBAR Validation Packet was written by a 25-year veteran of the Life Sciences industry and has been successfully executed at multiple pharmaceutical and medical device manufacturing facilities.