Regulatory Submission Content Management Solution (RSCM)

Overview

RSCM is software which manages lifecycle of regulatory documents for various regions including eCTD, aCTD and indexes for Rest of World (ROW) countries. Audit trails, electronic signatures, scanned signatures (physical signs) are 21 CFR Part 11 compliance.

Key Features:

  • Country-wise/Region-wise preloaded templates for eCTD or ICH or Country specific Indexes.
  • Documented pre-approval process for regulatory document create/change/obsolete activity.
  • All regulatory documents which go as a part of eCTD Submission / non-CTD can be effectively managed.
  • There is a seamless bridge between this software (RSCM) and Dossier-Mgmt an e-CTD software for regulatory submissions.
  • This bridge allows only reviewed and approved documents to be compiled into the eCTD for submissions thereby avoiding manual unintentional errors.
  • Affected submission report for a document used in different submissions.
  • Controlled Printing option available with audit trails.
  • Flexible country wise configuration at document type (Section) level. Users can define their process flow for every regulatory document type
  • Controlled Access : region/country wise access permission to users- access permission
  • Advanced search is available where user can search documents based on location, department, product, region/country, eCTD section, title, document no., version, key words and many more fields. Also user can search document based on 600 different combinations of fields
  • Parallel or In Sequence Review Option: document can be sent for review in parallel or in sequence i.e. for parallel review; more than 1 reviewer can review the document at same time
  • Change History: regulatory document change history viewing facility
  • Choice of converting word file to PDF during publish as per country/region wise regulatory guidelines
  • Provision of multiple attachments
  • Refer existing published document for different regions
  • Alerts: auto document expiry alerts via email & auto e-mail alerts for pending tasks