Operation & Compliance

Simplify Compliance & Reporting With YourDocs^© Subscription Service

“Corporate leadership may do well to reassess their organizations’ compliance infrastructure in light of the potential for exposure…the only available safeguards may be robust compliance operations that demonstrate ‘extraordinary care’.”

Managing health product and service information can be complex and carries significant challenges due to frequent changes in the regulatory environment. These challenges present an ever-present threat to full compliance. Many of the regulatory requirements are difficult, if not impossible to accurately manage manually and require additional staffing and constant maintenance. Maintaining accurate and current knowledge bases without electronic processes in place carries enormous risk and unnecessarily drains resources.

YourDocs^© Seed Library Available to Subscribers May Help You Manage Compliance and Disclosure Requirements Specified By Such Sources As:

Food and Drug Law Journal articles addressing industry communication of labeling information
Industry guidance presenting information regarding risks in prescription drug and medical device promotions
Guidance for Implementing Permissive Exclusion Authority [1]
FDA citations including: Guidance for Industry, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific reference publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices[2]
New England Journal of Medicine Health Law citations [3]
Corporate Integrity Agreement requirements [4]
Guidelines for Managing Conflicts of Interest
Code of Medical Ethics and Professionalism

YourDocs^© for Consistent and Centralized Audit Reporting

YourDocs^© Provides efficient cost-effective, paperless, solutions to labeling & literature distribution compliance
YourDocs^© Provides a single point-of-entry for all queries, thus giving you full control of responses for proof of compliance
YourDocs^© Provides transparency to regulators or auditors that you control
YourDocs^© Provides greater accuracy and efficiency compared to manual processing
YourDocs^© Provides Click-Simple compliance plan implementation
YourDocs^© Tracks & reports required client commitments traceable to the specific client
YourDocs^© Tracks & reports proof of client receipt and acceptance of your select information
YourDocs^© Decreases or eliminates the need for hard-copies & mailings
YourDocs^© Helps realize cost saving efficiencies
YourDocs^© Offers real time reporting 24 / 7