Validation mehtod for software system in place

COMPUTER SYSTEM VALIDATION (CSV)
1

Hello, everyone,

As medical device manufacturer, there has been a customized MES (Manufacturing Exexutive System) in place for many years. Now we want to validate this MES system. This is difficult to us to determin validation method for this in used sysetm.

we would like to use the method align with GAMP5 V module, means:

Planning --> Specification --> coding review --> Verificaiton --> Report.

so, can this one be accepted by FDA auditors? if cannot, can everyone provide the more proposal for this case?

2

Hello, everyone,

As medical device manufacturer, there has been a customized MES (Manufacturing Exexutive System) in place for many years. Now we want to validate this MES system. This is difficult to us to determin validation method for this in used sysetm.

we would like to use the method align with GAMP5 V module, means:

Planning --> Specification (including risk assessment) --> coding review --> Verificaiton --> Report.

so, can this one be accepted by FDA auditors? if cannot, can everyone provide the more proposal for this case?

Would be very happy to get comments or proposal.

Thanks a lot in advance.
Jasmine

3

Hi Jasmine,

I will rather suggest to go through the following approach which will cover the V life cycle validation approach by following SDLC.

Initiation–>Planning(PVP/VMP)–>Requirements Gathering (URS,FRS)–>Design (SDS)–>Development (Configuration Spec Docs/Code Review Docs)–>Qualification(QP/IQ/OQ/PQ)–>Implementation (VSR/SRC)–>Operation Maintenance Phase (Training Records).

This may be quite elaborative, but there are many documents in between to be prepared. I have documented above only few documents yet… :), phasewise.

Regards,
Sourav

4

Hi, Sourav,

Thanks very much for your reply.

I understood the above approach was very elaborative, but we have used this system for years in company, I wonder if “Development (Configuration Spec Docs/Code Review Docs) is needed? 2 considerations about this:

  1. Our system is running normally for years;
  2. It is hardly for us to get the development documents, especially coding, the system vendor quitted marketing already. 
    Under this context, can we simplify the validation approach of development phase?

Thanks

5

Hi Jasmine,

As per your first post I understood that you are going to validate this system to maintain compliance, as it is already in running state for years. You might be aware that validation is governed by the Project Validation Plan (PVP), so every validation deliverables should be mentioned in the PVP itself.

Before going ahead, let me clear to you that software code review documents are needed only in the case of Bespoke systems i.e. system which are in house built or custom applications. So in your case software code documents can be easily removed from your development phase documents.

Now the extent of validation will again depend on the risk assessment as well as it depends on the GAMP category in which it falls. If it falls under Category 3 (COTS-Commercial Off the shelf), where the system can be used as it is, the vendor itself will provide an IQ/OQ document for system qualification alongwith the System Design Specification and believe me no vendor is going to provide you any coding documents.Yes, but being a validation analyst in your organization, you need to create at least a configuration specification document, where you will document the software configuration details, hardware configuration details, server details and other technical requirements.

Making it simple, since you will be doing retrospective validation and since this system is already in use, there is no need for mentioning about coding. Because the auditors know it very well the system categories. For development phase you may now create Configuration Specification Document, Configuration Management Datasheet (CMD-This will help you to keep the baseline status of latest validation and configuration of the system), RTM initiation.

Please let me know if my explanation above helped you in simplifying your query.

Regards,
Sourav