There is a need to follow strict documentation with Document Control, SOPs, etc. with their audit histories for them to comply with GxP. As it is a regulatory requirement, we, as software vendor, we have tried to incorporate SOPs and have reviewed and modified them as time has gone by to comply with them.
US FDA’s and EU’s regulations – CFR 21 part 11 and Annex 11 are designed such that they give guidelines to companies to comply with GxP: and, mandated by regulatory authorities to ensure 360o quality.
As we know, CFR 21 part 11 deals with electronic records, and signatures, and software systems are required to be dependable and reliable when they generate such and for these software systems using which the resultant are electronic records, they need to comply with regulatory GxPs.
These regulations are dynamic and change according to the evolving software scenarios – the software hosting has evolved drastically over the years and today hosting on Cloud, SaaS (Software as a service) are “in” concepts. The server performance, server options… have given software hosting “wings”. With these technological and economic advances, software validation has also gone through change in tandem to meet with the evolving world of software hosting.
Despite saying this, not much has changed in the validation world. And, now software vendors are taking a smarter approach to software validation. Not seeing it as a “chore” or a mandated regulatory requirement, but following it as good development practices – including documentation. As one of such software vendors, we, @ Sarjen, have adapted to the changing scenario – with implementation an automated software development lifecycle over a platform which has also helped us to automate many processes, viz., SDLC (with validation documentation as its integral part), IT, HR, etc. giving a more structured approach to resultant software system and its quality, validation…
