Computerized System Validation in Pharma



Hello everyone,

Im QA senior and i have like target to validate our Coumuterized system in pharma, I started to work in some draft based in life cycle of software engineering but I don't know if im in the good way or not, I created our first SoP validation computerized system but us u said I ignore if im in the good way or not.

so If u have any proposition or suggection about this topic are welcome, or something like this.



Super Moderator
Without seeing exactly what you've done, it's hard to say; however, it does sound like you're on the right track.

Good practice includes establishing the software life cycle - this shows, especially, how you deal with changes, configuration management, etc.

Another good practice is to have a validation master plan (or master validation plan). This provides the framework for how you approach validations. This may be what you have started with your SOP. It establishes the scope and guidelines. You should take a risk-based approach, applying more rigor to the systems that can impact quality. You can establish your risk assessment methods in this document.

I always suggest documenting the inventory of software systems. That can be continuously reviewed and updated.

It's then common to have a validation plan for each system to validate. This provides the details how that system is to be validated and maintained in a validated state.

Then you'll have the validation protocols, execution results, and reports. I always suggest the report provide a conclusion that, based on the test results and that the controls are in place to enable the system to maintain a validated state, the system is validated.

You'll also want to have the means to capture and track issues. For any issue that remains open, you'll want to establish why the issue doesn't pose a risk to quality.

Hope that helps. It's a large topic, as I'm sure you're seeing so the more focused your questions are, the better the response you'll get.


Trusted Information Resource
i see the key to success in three steps... and respective linke.s

1. principles - policies / framework - procedures & formats.
CDFIC :(broken link removed)
USFDA :-(broken link removed)
PICS:-(broken link removed)

2. gap analysis - action plan (protocol ) for specific software or process.
GAP ANALYSIS :- (broken link removed)
2 (enclosed.)
3. execution.
(broken link removed)


well ISPEs GAMP guide covers entire spectrum with appropriate examples & templates. (but will cost)


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