how to avoid a medtech document & record scavenger hunt
TRANSCRIPT
How to Avoid a Document & Record Scavenger Hunt
BIOMEDevice BostonMay 7, 2015
Imagine the following scenarios• Your company is in the process of bringing a new
medical device to market
• Your company has an ever evolving QMS
• Your company will be inspected by FDA and/or audited for ISO
How are you managing these scenarios?• Battleship eQMS / eDMS?
• General purpose tools?
• Low powered legacy solution?
• Paper?
Do you . . .• Bury your Design History Files once the medical device
received regulatory clearance and is launched?
• Archive the Risk Management File after the product is launched?
• Ensure all aspects of your QMS are in sync?
+50%
The home of your documents & records
DHFs in binders? Find a test report in this pile.
Paper . . .
How does paper
work for global teams?
“E” systems convert paper to digital
Signed documents need to be scanned
Most “E”
systems are no
better than
paper
“E” systems – still a scavenger hunt
Documents are buried
Paper to “E” – frustrating
A new frontier
FAST!
TARGETED!
You need• Single Source of Truth• Reduce time during product development• Onboard resources FAST• Designed for Medical Device companies• Always audit ready• Resources more productive
