Validating a computer system
1997 FDA Office of Regulatory Affairs Compliance References: Bioresearch Monitoring (BIMO) Compliance Program 7348.808 Attachment A: Computerized Systems The intent of this attachment is to collect, in one place, references to computer systems of the program.
FDA Inspection Guide Guide to inspection of computerized systems in drug processing (search Google) The purpose of this guide is to provide the field investigator with a framework upon which to build an inspection of drug establishments which utilize computer systems.
FDA Guidance - 21 CFR Part 11 Part 11 FDA Industry Draft Guidance on Validation This draft guidance has been withdrawn form the FDA Website as part of the drug CGMP initiative for the 21st century.
However, most of the statements in the guidance are still very much appropriate and subject to FDA inspections.
There will have been a process for deciding what does and doesn’t get included in each Sprint and the process and the decisions made from following it need to be documented formally.
It is recommended that decisions are not contained in informal meeting minutes from which it’s not clear what has and hasn’t been included and why, but in a formalised signed off document.
Hello and welcome to the latest MHRA Inspectorate Blog post, my name is Balall Naeem, GCP Inspector, and you may already have read my previous posts on Reference Safety Information (RSI).
This post focuses on Computer System Validation (CSV) and is a combination of a case study seen at a single organisation and some of the common findings GCP Inspectors have seen across a number of recent inspections.
Well we now have the possibility of there being untested and therefore unvalidated functionality in the live system, but before this can be established there were a number of questions that required answering.So at the starting point of attempting to assess whether the system was in a validated state, it was not possible to identify all the user requirements and functionality that were included in the build and therefore confirm that these had been validated.Yes, as I eluded to earlier the specification documents may be in a state of flux and being updated as part of staggered Sprint builds, the content of which is impacted by resourcing, timelines and evolving user requirements, but at some stage it will be finalised and should be documented.Of the four items selected, test scripts could only be found for one of them and this was recorded as a failure.Following the failure there was no documented evidence to demonstrate the issue had been rectified.