10 Sure-Fire Tips for Developing a Document Management System Any Investigator Would Love

Note: Due to circumstances beyond our control this webinar has been postponed.

Is your documentation still paper-based? Did you know that “… practices that demonstrate a lack of control over both paper and electronic documentation” are the second-most-common deficiency cited by FDA examiners? Are you reluctant to convert to all-electronic because the cure could bring on more problems than the cause?

It’s time to take electronic documentation seriously — before your next audit, before your next FDA inspection. Mark your calendar for a standout FDAnews webinar where you’ll discover 10 tips for making a conversion that’s relatively painless — and pays huge dividends down the line.

Consultant Nikki Willett, CSO at ComplianceQuest, is your guide. Ms. Willett is a pro at helping FDA-regulated firms navigate the often-complex path to all-electronic documentation. She understands the need for culture change and how to accomplish it with minimal disruption. If audit time is trauma time for your organization, tune in and discover these 10 tips:

  1. Approval paths: Parallel and tiered approval processes that eliminate waiting for each individual to provide approval/rejection
  2. Printing and watermarks that eliminate obsolete documents
  3. Connecting to document training: Notifying stakeholders and capturing signoffs for compliance
  4. Quick retrieval of the right document at the right time for the right person … searching and metadata … creating different views
  5. Unified/standardized document templates to enforce compliance
  6. Obsolescence: Controlling lifespans of documents
  7. Creating detailed reports that pinpoint documents that are missing or need revision
  8. Optimal naming and numbering schemes for documents, files, folders and cross-referencing
  9. Access control and retention policies to protect sensitive information, and finally
  10. Integrating documents with other quality processes.

Simplify audits, put a smile on the FDA inspector’s face, and get started on feasible path to electronic documentation. Register now.

BONUS: Order the webinar plus audio recording/transcript or the 24/7 encore plus audio recording/transcript for $487, and receive a FREE copy of Top Ten Data Integrity Traps: How to Find and Fix Problems (retail value $177).

Top Ten Data Integrity Traps: How to Find and Fix Problems
Is your manufacturing and lab data reliable? Will it pass muster with regulators? Are you 100% sure? Virtually every area of your operations impacts the integrity of your data. If you want to lock down your systems to make sure data errors can’t creep in, you need to identify the common — and often critical — gaps that can lead to serious data integrity problems. This report shows you where most data integrity problems occur and helps you create a plan to weed them out — and keep them out.

Who Will Benefit

This webinar is designed to aid anyone working in a regulated environment and creating/managing documents. Specific job responsibilities include:

  • Quality assurance
  • Quality control
  • Document control


Meet Your Presenter

Nikki Willett


Nikki Willett has worked with document management solutions since the early 1990s across highly regulated industries, including experience with Accenture, Pilgrim Software, ComplianceQuest, Documentum and other document management software firms. She founded the LinkedIn Quality & Regulatory Network Group with more than 113,000 professional members worldwide.

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