Regulatory Information Management Tool | ViSU

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WWW. DDISMART. COM
TRACK AND MANAGE YOUR REGULATORY
ACTIVITIES REGULATORY INFORMATION MANAGEMENT
VISU
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RIM Tool by VISU
HOW ARE YOU MANAGING YOUR MEDICAL DEVICES
REGULATORY INFORMATION / REGISTRATIONS /
COMMITMENTS COMPLIANCE?
WWW.DDISMART.COM
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1. INACCURATE REGULATORY INFORMATION
4 RISKS IN RELYING ON THESE TOOLS/SOFTWARE TO
TRACK MANAGE YOUR REGULATORY ACTIVITIES
As these are all general-purpose tools, it is
very hard to gather all regulatory information
in a structured manner within a stipulated time.
This often leads to incomplete information which
leads to either overlook by teams or extra
efforts to gather information from different
sources.
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4 RISKS IN RELYING ON THESE TOOLS/SOFTWARE TO
TRACK MANAGE YOUR REGULATORY ACTIVITIES

• 2. IMPROPER REQUIREMENTS EXTERNAL TEAMS
• ACCESS
• Trackers created using Excel usually are stored
  on the authors computer and are not accessible
  by other teams (locally globally) in
  real-time. This makes it harder to share,
  validate, and track changes frequently leading
  to incorrect requirements which may cause delays
  in regulatory submissions or answering notified
  body findings.

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3. COMPLIANCE RISKS
4 RISKS IN RELYING ON THESE TOOLS/SOFTWARE TO
TRACK MANAGE YOUR REGULATORY ACTIVITIES
Most importantly it is very easy for
regulatory information to fall through the
cracks when using Excel/PLM/ERP to manage them.
Even critical information can be lost when the
resource who is handling these sheets forget to
update, or gets reassigned to other projects, or
leaves an organization.
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4. TECHNOLOGY BURDEN
4 RISKS IN RELYING ON THESE TOOLS/SOFTWARE TO
TRACK MANAGE YOUR REGULATORY ACTIVITIES
If companies create their own in-house
systems for this, the tightly coupled
integrations and the complexity that comes with
it makes the upgrades very challenging when the
business requirements change. With cloud based
3rd party tools, this risk is greatly mitigated.
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