Documentum LSQM Implementation - Perrigo via OpenText
Business Challenge
The Challenges faced by Existing environment
Business requires the complete lifecycle of GxP documentation in compliance with applicable regulations including the creation, amendment, approval, use, and retention of all required GXP documentation. This electronic document management system will be providing full traceability, ensuring data integrity and compliance with Good Documentation Practice to meet the necessary regulatory standards.
Harmonization across sites for our Quality Management System (QMS) requires a real time Electronic Document Management System (EDMS) that all sites can access and manage documents including version control. Documentum is an out-of-the-box solution providing the ability of lifecycle management. This includes the creation, approval, release and periodic review of controlled quality and manufacturing documentation, and as such, is foundational for GxP strategic Quality.
EDMS is a 24X7 application and has users across multiple regions - America, APAC, Europe, EMEA.
Solutions Offered
EDMS is built upon Documentum D2 LSQM module. It consists of 3 document categories - Category1, Category2 and Category 3.
Category 1 has the highest level of controls and a final state of Effective
Named “QM Cat 1 Controlled Document Lifecycle” in the system.
Some features specific to Category 1 are:
Pending Release and Effective States
TBR Workflow
Periodic Review
Two level approval with esignature
Coordinator has oversight.
Requires a Change Request to be created, revised or withdrawn.
Subject to print and export controls
Examples of Category 1 Documents: Governance and Procedures (SOPs, Work Instructions, etc.), Master Manufacturing Documents (Batch Records, Methods, Specifications), Packaging and Labeling Documents
Category 2 is for documents that require a formal approval (eSignature) but are not trained on and do not go through a periodic review.
Category 2 documents have a final state of “Approved” (not Effective) and no Pending Release State
Some features specific to Category 2 are:
One level Approval with eSignature
Ability to send directly for approval.
Coordinator oversight not required.
Examples of Category 2 Documents: Master Validation Documents, Training and Reference Documents
Category 3 is for documents that are typically created or approved outside of the system and scanned or imported into the system
Some features specific to Category 3 are:
No watermarks
Ability to self approve.
External approval or effective date can be assigned.
No signature
SKILL SET
Documentum D2 LSQM
** Confidential with vedya Info Solutions Pvt Ltd **
Captiva Capture Upgrade Solution
Archive Centre Upgrade Solution 
Support Service Solution
Vendor Invoice Management
Archive Centre / Content Server
Archive Centre Upgrade Solution
Archive Centre Solution
Salt River
Altria
West Bend Mutual Fund
Dunedin City Council
Maruti Suzuki india Limited
Vendor Invoice Management
Massmart 
Google
Transport for NSW
Jeddah Central