Implementing the PRRC role in a company

[Loona]

Dear Elsmar forum,
How are you implementing the PRRC role in a company to ensure his/her responsibilities are met? If you implement the role via delegation, how do you keep oversight of his/her responsibilities? Thanks!

 

[chris1price]

Ideally, the roles of the PRRC should be in their Job Description together with the requirement that they have the qualifications listed in the MDR.

 

[Philip B]

Agree with Chris, we also document the PRRC role in our quality manual and on our organisation chart (showing suitable independence). The PRRC is also the key role in our 'Strategy for Regulatory Compliance' procedure.

 

[Loona]

Thank you both for sharing that. How is the operational system you put in place to ensure the PRRC has the appropriate oversight? Thanks!

 

[Philip B]

It will be different for every company but you need processes that ensure that the PRRC has regulatory oversight where applicable. You can document these processes in your strategy for regulatory compliance, also as Chris mentions in the PRRC job description. You need audit and review processes to ensure that the measures are effective. Good change control is also key, trying to stop others changing things without PRRC oversight. Easier said than done I admit, almost impossible in my company to get some departments to comply eg transport. Good luck!

 

[Loona]

Thank you Philip for your guidance! Indeed a challenge to implement the PRRC role! Thanks

 

[critesw]

It will be different for every company but you need processes that ensure that the PRRC has regulatory oversight where applicable. You can document these processes in your strategy for regulatory compliance, also as Chris mentions in the PRRC job description. You need audit and review processes to ensure that the measures are effective. Good change control is also key, trying to stop others changing things without PRRC oversight. Easier said than done I admit, almost impossible in my company to get some departments to comply eg transport. Good luck!

Philip - would NB auditors specifically be looking for an SOP for Strategy for Regulatory Compliance?

 

[Philip B]

You have to have a strategy for regulatory compliance but it doesn't have to be an SOP, you could demonstrate it through other means. We have an SOP as I find it useful to have a summary in one document.

 

[Device2020]

You have to have a strategy for regulatory compliance but it doesn't have to be an SOP, you could demonstrate it through other means. We have an SOP as I find it useful to have a summary in one document.

Do you mind sharing your SOP for regulatory compliance? Keen to know what you've included and how much detail.
Thanks in advance