Software validation question - Contract Manufacturer - ISO 13485 implementation

[Kari]

Hello -

I work for a contract manufacturer going through a 13485 implementation. The company handles both turn-key and consigned production of finished medical devices. I'm wondering whether we must validate our computer based production/accounting system. The system has been in place for many years, but was upgraded about a year and a half ago.

The system is used for things such as:
• Generating hard-copy purchasing information
• Tracking lots and quantities of components available for use in production
• Tracking production times
• Electronically “moving” quantities from one production area to another
• Generating hard-copy paperwork required for shipping
• Billing

The system is not used for things such as:
• Component traceability (kit lists)
• Production records
• Inspection/test records
• Distribution records
• Inspection/test records

(In each case, a hard-copy form is used to fulfill record-keeping requirements):

We have never been cited by the FDA for not having this computer system validated, since it is not used for recordkeeping, or process flow. (The system is used to create the traveler, but a hard-copy printout is used in production, rather than the computerized version. So with respect to 21CFR part 11, we are using the system as a "typewriter")

It is unclear to me as to whether this system would be considered “computer software… for production and service provision that affect the ability of the product to conform to specified requirements.”

Can anyone help me out with the ISO 13485 interpretation regarding this computer system? Thanks for any assistance.

Kari

 

[Al Rosen]

Hello -

I work for a contract manufacturer going through a 13485 implementation. The company handles both turn-key and consigned production of finished medical devices. I'm wondering whether we must validate our computer based production/accounting system. The system has been in place for many years, but was upgraded about a year and a half ago.

The system is used for things such as:
• Generating hard-copy purchasing information
• Tracking lots and quantities of components available for use in production
• Tracking production times
• Electronically “moving” quantities from one production area to another
• Generating hard-copy paperwork required for shipping
• Billing

The system is not used for things such as:
• Component traceability (kit lists)
• Production records
• Inspection/test records
• Distribution records
• Inspection/test records

(In each case, a hard-copy form is used to fulfill record-keeping requirements):

We have never been cited by the FDA for not having this computer system validated, since it is not used for recordkeeping, or process flow. (The system is used to create the traveler, but a hard-copy printout is used in production, rather than the computerized version. So with respect to 21CFR part 11, we are using the system as a "typewriter")

It is unclear to me as to whether this system would be considered “computer software… for production and service provision that affect the ability of the product to conform to specified requirements.”




Can anyone help me out with the ISO 13485 interpretation regarding this computer system? Thanks for any assistance.

Kari

As you have described, I don't think you need to validate it according to the standard.

 

[Kevin Mader]

Kari,

I agree with Al. My comment here though is to ensure that you make a declaration within your Quality System documents stating that the validation of the ERP system is not necessary due to given reasons.

Since you are probably working from hardcopies of BOMs (masters doc controlled) in manufacturing, you can claim that you are working from approved documents rather than data records. Be sure that the BOMs are approved and released appropriately.

Regards,

Kevin