Documentum and ARGUS / ARISg Integration for Pharmacovigilance
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…