What is electronic submissions and regulatory correspondence management for Life Sciences
Compliance and security are compromised when records are scattered across a variety of repositories, laptops, collaboration spaces and shared drives. Related communications, such as emails, meeting minutes and phone records, can also present tracking challenges. Electronic submissions and regulatory correspondence management keeps current, complete records of all documents and communications associated with the drug applications submitted to regulatory agencies, both directly and through affiliates.
OpenText Documentum Submission Store and View features
Find everything in one place
Easily retrieve the regulatory correspondence associated with applications and submissions with a 360-degree view of regulatory activities.
Secure repository for published output
Efficiently track submissions and associated correspondence with audit trails and indexing for clarity and increased visibility into communications with regulatory agencies.
Provides standard eCTD views, single, current and cumulative, of the full regulatory application lifecycle, including navigation of hyperlinks. Standard cabinet-folder hierarchy allows navigation and views of the NeeS or paper submission.
Connect source and published output files
Link source documents to the respective published output file for complete traceability from authoring to submission.
Drag and drop emails with attachments from Microsoft® Outlook® to create a single record for the respective communication.
Benefits of OpenText Documentum Submission Store and View
Enhance submission visibility
Get a complete view of regulatory activities within application displaying submission and correspondence records in a single view.
Improve time to market
Ensure efficient and transparent tracking of open/closed queries and speed responses to health authorities.
Move submission files off uncontrolled file shares into a secure, compliant repository.
Further strengthen compliance by setting access control, password strength and log-in attempts to ensure appropriate access to content.
Contact us to speak with a member of the Life Sciences team