Regulation 536/2014 – starting Jan 2022

In January 2022, Regulation 536/2014 will become a new central European law stipulating that the eTMF must be stored and retained for a minimum of 25 years.
 
Are you confident that your eTMF and clinical trial data will remain safe, accessible and readable for that time?

Below are just some of the considerations you must take when archiving data:

• What do you have in place to avoid data loss or corruption?
• Are you protected if you suffer hardware failure?
• Can you maintain your files in readable formats throughout the entire 25-year period?
• Are you capturing an audit trail of who has accessed which data?

If not, then you could be at risk of manufacturing delays, lengthy inspections and damage to your reputation.
 
Here an article regarding this new regulation and how it may affect you.