Regulations require storage of eTMF and clinical data for retention periods as long as 25 years or the lifespan of the product. At the same time, this content must be stored according to ALCOA+ principles. With increasing amounts of distributed data, and an increasing number of systems and partners to manage, the ability to centralise and manage data for the long term is more challenging than ever.
You’re on top of your organisation’s compliance and regulatory requirements but do you have data preservation and long-term access of your data under control?
In regulated markets, the problem of digital data preservation becomes even more complex as you have to maintain compliance of that data for decades and continue to meet regulatory requirements at all times, regardless of if you interact with the data or not.
In this webinar we provide insights into some of the challenges and solutions to this compliance hurdle:
- What is digital data preservation and why do I need it?
- eTMF Archives and the EMA guidance
- GcP inspections; is your data inspection ready?
View the recording by clicking here.