My company is in the process of building a Microsoft NAV based ERP system. As my background is mostly equipment and utility validation, I am by no means a CSV sme. Does anyone have guidance on how to approach this? I’m familiar with part 11 compliance but I’m not sure how to structure the validation approach for this system or even if it is capable of being configured as part 11 compliant…any advice would be great!
Hi hokiefan6688,
Do you have a URS developed for this system?
Thanks
Not currently…I’ve read that a risk assessment should sometimes come before the URS…I guess I’m kind of lost. Do you think it’s wise to follow the GAMP V-Shape model? We are a class 2 medical device manufacturer so I wasn’t sure what was necessary…
Yes you could do a high level risk assessment initially and find out the criticalty of the system and how it affects patient safety, product quality and what are the underlying business risks.
The cornerstones to starting this project should be:
A: A Validation Plan
B: Risk Assessment
C: URS
Usually the outcome of the risk assessment will dictate what documents you need to generate and that will be stated in the validation plan.
Can you reference any other CSV projects that you have already done on site?
Has your CSV team created a roadmap for CSV projects previously?
I’m just trying to get a handle on what kind of support you have,
Regards
Thanks Graham i appreciate it.
We are a ~20 person start-up company (11 when I started). Due to tight budgets and limited resources, myself and my director have implemented a mostly paper based quality system for now. The components of our device are contracted out and validated by other companies. We do the final assembly at our site, but do not currently have a robust CSV program. The ERP system is going to replace accounting, purchasing, supply chain, and production.
Ok so I understand better, so yes the risk assessment is going to play a key role in how you validate this system as it has many different aspects so directly affecting product quality like the production component while others such as accounting may not need the same rigor of testing.
I would recommend this book written by @yodon to help you with your validation plan:
http://learnaboutgmp.com/books/writing-a-master-validation-plan-plain-simple/
I would also perhaps start a new discussion thread using the Risk Assessment tag so we could focus on that first and help you out there.
My advise is not to get overwhelmed and take one step at a time.
Hope that helps.
I’ve inherited an ERP system which was validated. The ERP system will have some functions which are not-GMP (like accounting) and some systems which are GMP (like inventory management for expiry dating, shipping, and production).
I agree with gokeeffe, a URS should be your starting point. Basically, what do you want the system to do? Will it make decisions for you (like expiration dating?) Will it contain all your production records, or will these be kept on paper and copied for archival purposes?
The URS might seem like an added step, but it is like a road map that you discuss with all stake-holders. When you drive anywhere, the first thing you do is select a destination, then figure out the best way to get there. The URS/Risk assessment defines your goals and potential hang-ups.
This is typically the 1st step people skip, but is often the difference between a fully delivered product, and one that is half-baked. Also, if you hire out contractors to help with this, the 1st question they (should) ask is - do you have a URS. They know from experience that the finished product’s quality is founded on the existence of a URS.
Also, if you don’t know everything about what you want - that’s OK - use the URS as a discussion platform. As things come up the URS will always change and be modified, and is expected.
