Protocols - Pharmaceutical & Medical Device

Howdy, I am a Validation Specialist here in the USA. I work for a Nutra-ceutical company and I am currently doing the same thing, with the added task of validation of the equipment and processes. I would like very much to discuss the task at hand.

Hello (Howdy!!) Logix101, thanks for your response. In addition to the above I am also putting together templates for Validation Plans (VMP), risk assesment (forms and procedures),deviation handling (forms and procedures) etc that will hopefully be used across all the different sections (equipment, software, process). I think that one VMP/IQ/OQ etc template will suit and it will just be the content that will vary as needed.

My goal in all of this is to actually reduce (from the current level that most Pharma and medical device companies have) the amount of paperwork involved in the validation activity and hence reduce the time and effort - basically I want to focus the validation effort and only gather relevant data and documentation. I firmly believe that validation (in the broad sense) has major benefits for a company and not just in satisfying the regulatory agencies.

In addition to the FDA we also have to satisfy EU and Japanese regulations among others -I don't think that satisfying all regulations with a single template will be a major issue.

Yes I would also like to discuss the task at hand - hence my post. Not sure how we proceed from here. Any ideas ?

If you already have protocol templates, you are most of the way there. If you are trying to make 1 size fits all templates, they will end up very broad and big. The end user/author will then have to chop out a lot of non-applicable stuff. Computer/PLC based systems should be treated seperately.

To save a lot of time and grief, if using Word make sure the formats are set up properly with fonts, numbering, etc. and document automation.