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Documentum and ARGUS / ARISg Integration for Pharmacovigilance

Documentum – Argus / ARISg Integration

Documentum – Argus / ARISg Integration

Integration of Argus and Documentum to improve efficiency in managing patient safety data

Secure content storage

Secure content storage

Leverage the scalability and security of CARA/Documentum for storing Serious Adverse Event (SAE) data

Cost Savings

Cost Savings

From reduced licensing, consolidated (regional) case processing, reduced resource needs, and deduplication of records.

Centralized and Compliant Storage

Centralized and Compliant Storage

Maintain documents received from global sites in a central repository in a 21 CFR part 11 compliant repository

About the issue

  • TB of data causes performance issues in maintaining documents in Argus / ARISg
  • Data redundancy – multiple copies of same document kept in Argus / ARISg databases due to the need of the same document that needs to be tied to multiple cases
  • Costs – User access for licenses are higher in Argus / ARISg
  • No documentation archiving solutions for Argus / ARISg
  • No central repository for maintaining documents in a validated system
  • Little integration with documents which are then used in submissions

CARA / Documentum

  • CARA/ Documentum is used for document initiation and sending over to Argus / ARISg Intake area
  • CARA/ Documentum receives Argus/ ARISg documents associated with cases for archival with better compression method.
  • Processing of documents (such as redacting) is done in CARA using proper permissions and version controls.
  • Medical Records, workflow checks, and validations built into the process
  • Completed case information is received from Argus / ARISg and documents are moved into a completed folder.
  • Automated QC process for moving input records to QC check folders
  • Intake Worklist – Includes metadata around patient cases along with the file
  • Metadata for cases include data points such as Country, Data, Product, Event

ARGUS / ARISg

  • Patient cases are created in Argus / ARISg
  • Document Intake area created to receive input files from Documentum so files don’t have to be entered directly into Argus / ARISg
  • Sending files directly to Argus / ARISg without using their user interface
  • Argus / ARISg direct integration features leveraged.
  • Documents are added to either a new case or a follow up to an existing case
  • Same document from CARA content store is used in multiple Argus / ARISg cases for faster processing times and increased in efficiency
  • Cost savings from reduced Argus / ARISg licenses
  • Integration account is used to maintain CARA/ Documentum security privileges

Single Point of Truth

  • We provide a VAP (Validation Accelerator Pack) for CARA and ARGUS / ARISg
  • Enables customers to meet industry regulations such as 21 CFR Part 11
  • Single Point of Truth is maintained in CARA / Documentum for regulatory purposes
  • We provides additional project management / implementation services

Over 360,000 users and growing…

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