how to avoid a medtech document & record scavenger hunt

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

Jon Speer

jon.speer@greenlight.guru

(765) 346-3987