USDM develops a connector that allows Argus systems to be integrated directly with CARA for Documentum.

1. www.usdm.com
www.generiscorp.com
CARA / Documentum and ARGUS
Integration for Pharmacovigilance
Documentum – Argus Integration
Integration of Argus and Documentum to improve efficiency
in managing patient safety data
Secure Content Storage
Leverage the scalability and security of CARA/Documentum
for storing Serious Adverse Event (SAE) data
Centralized and Compliant Storage
Maintain documents received from global sites in a 21 CFR
part 11 compliant central repository
Cost Savings
From reduced licensing, consolidated (regional) case
processing, reduced resource needs, and de-duplication of
records

2. The Issue
Contact us for a demo or evaluation
www.generiscorp.com www.usdm.com
USDM provides a VAP (Validation
Accelerator Pack) for CARA and
ARGUS
Enables customers to meet industry
regulations such as 21 CFR Part 11
Single Point of Truth is maintained
in CARA/ Documentum for
regulatory purposes.
USDM provides additional project
management / implementation
services
USDM
ECM
• CARA/Documentum is used for document
initiation and sending over to Argus
Intake area
• CARA/Documentum receives Argus
documents associated with Argus 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 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
• Patient cases are created in Argus
• Document Intake area created to receive
input files from Documentum so files
don’t have to be entered directly into
Argus
• Sending files directly to Argus without
using Argus
• Argus direct integration functionality
was 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 Cases for faster
processing times and increased in
efficiency
• Cost savings from reduced Argus licenses
• Integration account is used to maintain
CARA/ Documentum security privileges
CARA / Documentum ARGUS
Argus doesn’t have web services built in
Large volumes of data cause performance issues in Argus
Costs – User access for licenses are higher in Argus
No central repository for maintaining documents in a validated system.
Unsecured offline processing of files in personal machines
Data redundancy – multiple Argus cases requires multiple copies of same document
No archiving solution for Argus