Is RA (Regulatory Affairs) to stay under QA (Quality Assurance)?

max.polix

Involved In Discussions
In my organization we are considering to change the position of RA, from under QA to an indipendent branch.

The reason is mainly because RA has taken more and more importance in the strategy of the Company and has its own plans and budget.
RA is fast moving and product oriented, while QA is process oriented and actually slower.

I wonder whether anybody can share their experience about their organization.

Thanks.
m.p.
 

somashekar

Leader
Admin
Re: Is RA to stay under QA?

RA is fast moving and product oriented, while QA is process oriented and actually slower.
I do not know from where you could gather about such speeds, but all that I can comment is that RA is a specialist task to be performed by suitably trained and experienced personnel or group of personnel.
 

Bev D

Heretical Statistician
Leader
Super Moderator
In my organization, RA is separate from QA for the very reasons you mention. In fact RA reports under legal...it works for us.
 

max.polix

Involved In Discussions
Re: Is RA to stay under QA?

I do not know from where you could gather about such speeds, but all that I can comment is that RA is a specialist task to be performed by suitably trained and experienced personnel or group of personnel.
Need for High Speed: standards are evolving, regulations are changing, regulatory focus is changing (safety, clinical, mobile apps, ...), emerging countries are more important than only a few years ago, products and technology are changing, ...
 

kuyakut

Involved In Discussions
In our organisation RA is under the QA department but they work independently and only reporting to the QA Director who is the head of QA. They have separate budget also.


Kuyakut
 

AnaMariaVR2

Trusted Information Resource
I believe RA or QA's speed depends on the direction taken by the company & commitment to pursue certain products/services. Therefore, both RA & QA can go as fast or as slow as the company decides to go.
QA has new standards arising, expectations to keep up with.
 
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