EQMS Validation

[srkn14]

Recently heard about South Africa's standards store:
https://store.sabs.co.za/satr-80002-2-ed-1-00-2144082.html shows 1120,10 Rand which google today sets at 60ish US Dollar.
Up till now I've bought at EVS where the EN editions are markedly cheaper, but pure ISO isn't. Haven't had a reason to buy at the above website yet, so let us know how it goes (if you do).

Haven't got a chance to explore this further, yet! Thanks for the information.

 

[srkn14]

You have to purchase it; e.g., from the ANSI Webstore. They are apparently pretty proud of it, at > $500!

On the similar note, may I please know what is the best reference for GxP Classification of a system to develop a template that we end up using a system is GxP or not? Thank you for your time and information.

 

[Qualityseeker22]

Hi,

I need to validate an eQMS solution. As I am new to this area, I would greatly appreciate your input. My current plan is to leverage the validation documentation provided by the eQMS supplier. Specifically, my general strategy is as follows:

1. Define the intended use and requirements of the eQMS solution.
2. Document a Master Validation Plan, including a justification of the required level of validation using a risk-based approach.
3. Execute test cases as part of the validation process.

Could you please confirm if I am on the right track?

Additionally, regarding the risk-based approach, could you provide any suggestions or examples of what a risk-based rationale might look like for an eQMS solution?
In general, is software used for QMS considered high-risk, or is the risk profile more closely tied to the level of confidence in the software?

Many thanks in advance for your assistance!

Yes, you are in the right Church Are you accounting to a 'Performed by" and Approved by You need a Computer System Validation SOP that lists your steps you are going to perform. Your test cases need to be broken up in IQ, OQ and established ways to deal with test cases fail. Once that is buckled up with all failures being retested and passes. Quality needs to approve the packet. Then you can perform the PQ and if that passes. You can go live. Make sure everyone has been trained to the user roles. Make sure you have a procedure of how updates will be handled and regression testing to ensure the updates have had no effect on the database. Make sure you have procedures for periodic review. Also make sure the system can produce an Audit Trail report that lists the change, the reason for change and a time/date stamped approval.

Hope this helps.