Risk Evaluation and Mitigation Strategies (REMS)

COMPUTER SYSTEM VALIDATION (CSV) COMPLIANCE SOFTWARE
1

Hello All,

Does anyone know about any good article or application for Risk Evaluation and Mitigation Strategies(REMS) for pharma. and Anyone is aware that, Whether this type of software developement follows any special System Developement life cycle approach or GAMP is fine.

Can someone please throw some light on this?

Thanks,
Mahendra

2

REMS are programs implemented after a drug has been marketed, to manage any serious risk associated with the product.

For Eg; If in using a product named ABC if there is a risk of excessive bleeding, then :

Risk = Excessive Bleeding - loss of life
Goal = To stop / control excessive bleeding
Mitigating Strategy = Inform patient and the drug prescribers on the risk involved and a need for appropriate patient selection.

REMS is being interpreted and implemented in many ways but much like Computer System Validation the end goal is a controlled / tested and documented system in place.

Hope this helps.

3

Hello Guru,

Thanks for the helpful information.

–
Mahendra