PharmDev Innovations

Documentation

Citation from the US green immigration form any traveller coming from one of the Visa Waiver countries by plane (I-94W Nonimmigrant Visa Waiver Arrival/Departure Form) has to complete:

"The burden for this collection is computed as follows: (1) learning about the form 2 minutes; (2) completing the form 4 minutes for an estimated average of 6 minutes per response. If you have comments regarding the accuracy of the estimate, or suggestions to make this form simpler, you can write to ... "

This shall obviously tell the traveller that it is "peanuts" when talking about time efforts to be spent for completion of this document. However, every little counts and is adding up.

A consequent and complete documentation is a must for any well managed GMP system.

SOPs (Standard Operating Procedures) do play a key role. However, quite often the attribute "standard" is overlooked.

Our experience has shown that a number of > 300 SOPs per site cannot be organised (versioning, distribution, return, training, training documnetation etc.) any more and nearly inevitably leads to inspectional findings.

We'll help you in purging your SOP system and getting rid of any "overweight" in order to make it efficient again.

Don't accept and don't go that far that for one topic several SOPs with different titles but identical content "survive".

Keep your SOP system clean and lean, tidy and transparanet for all who have to follow the SOP's rulings.

Make sure that the SOPs are actually followed. Do never accept that anybody prefers to follow his personal unstructured writen notes in his pocket rather than the SOP (because the SOP is perceived as "silly"). This actually was a fraud (what in particular the FDA likes very much ;-) Make your SOPs living by having them representing reality !

We'll show you how to keep your SOPs alive such that every body accepts a SOP as a working aid and not a working hurdle.

Generation and maintenance of all other types of documentation is supported by us as well, of course (site master files, development reports, supplier assessments according to Annex 16, etc.).

No job is finished until the paperwork is done !

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