Hi, I would be very interested in the group’s opinions on ‘Paperless Validation’. I recently attended a webinar by
http://www.abacusbpm.com/validation_lifecycle_management_capabilities.aspx
and was impressed by their offering. I represent a start-up MES software provider and we are currently evaluating development/validation strategies. Does anyone in the group see compliance issues (FDA, customer audit or equivalent) with a ‘Paperless Validation’ to GAMP5 based software development? Thank you!
I have seen this webnair and another from a different company. Very interesting stuff, although I am not sure how this would work in the real world. It is customary today for the validation to be outsourced with the client Quality having final approval of documents. You would need the client Quality buy in very early in the project to go this route as they would want SOP’s to ensure that things are being done as expected. I can see how this could save a great deal of time, if set up right in the beginning. I fear that the first few projects trying this will not have the support or resources necessary to implement it correctly. And then it will get a bad reputation. From a vendor point of view, trying to bundle this package with a system or software would be difficult because of the in house procedures on commissioning, qualification and validation. On another note, I have seen a few different databases that are used to generate protocols from templates and this is the next step past that. The underlying problem will be the same. If set up right and the correct information put in, it will work good. But in today’s fast track projects you end up not having the information early enough and end up with a database that has garbage for the input and therefore your output is also garbage.
Its more or less similar to paper validation in stratigic point of view, largely the challenge will be meeting the part 11 compliance requirement of all the clasues,coz we need to maintain electronic documnets for all the protocols,script etc. Few of the applications which are meant for e-validation,will not support centralized domain user name, this will be more challenging.
Main changes over paper validation
1)elecronic signature
2)Audit trials
3)Electronic documents archival
4) Data integrity