Change Effective, implementation, routine use…these are all terms that swirl in change control, and can mean several different things depending on your organization. So what is truly important to track?
Taking a look at the above process map I want to focus on three major points, what I like to call the three implementations:
- When the change is in use
- When the change is regulatory approved
- When product is sent to a market
The sequence of these dates will depend on the regulatory impact.
|Tell and Do||Do and Tell||Do and Report|
|Change in use||After regulatory approval. When change is introduced to the ‘floor’||When change is introduced to the ‘floor’||When change is introduced to the ‘floor’|
|Regulatory approval||Upon approvals||After use, before send to market||Upon reporting frequency (annual, within 6 months, within 1 year)|
|Sent to market||After regulatory approval and change in use||After regulatory approval and change in use||After change in use|
I’m using ‘floor’ very loosely here. “Change in use” is that point where everything you do is made, tested and/or released under the change. Perhaps it’s a batch record change. Everything that came before is clearly not under the change. Everything that came after clearly is.
You can have the same change fit into all three areas, and your change control system needs to be robust enough to manage this. This is where tracking regulatory approval per country/market is critical, and tracking when the product was first sent.
A complicated change can easily look like this (oversimplification).
Is this 1, 2 or 3 processes? More? Depends on so many factors, the critical part is building the connections and make sure your change control system both receives inputs and provides outputs. Depending on your company, the data map can get rather complicated.