eSAM - for Life Science
Implementing and operating Enterprise Asset Management in Life Sciences poses some significant GMP challenges
Some of the more noteworthy challenges include:
- Job Revision Control
- GMP Equipment Delineation
- QA Involvement in Work Order Process
- Manual Calibration Management Efforts
- Equipment Data Quality
- Asset and Inventory Item Onboarding
- Implementing Non-Calendar Based PM’s
EDI is proud to introduce eSAM to address these challenges.
As a full service consulting and software development firm specializing in maintenance process improvement, Enterprise Asset Management implementations, quality asset data, and compliance practices in world-class maintenance programs, we have amassed a significant amount of experience and deploying unique solutions in the Life Sciences / Pharmaceutical industry.
eSAM is our solution that integrates into one product and services offering these unique solutions and IBM Maximo Asset Management technology. eSAM addresses the challenges of GMP with Strategic Asset Management.
- Integration with QA and Change Control Systems
- Equipment Data Standards, Collection and Cleanup
- Calibration Expertise
- Online Asset, Work and Item Requests
- SOP to Job Plan Conversion
- Quick-Start GMP Workflow
EDI specializes in implementations of Maximo in federally regulated environments. Our experience in the Pharmaceutical/ Life Sciences market has allowed us to develop unique solutions to operate under FDA regulations; particularly meeting the requirements of CFR 21 Part 11, and complying with the GMP described in CFER 21 Parts 210 and 211. In addition, EDI is one of few services firms who has completely rolled-out, through go-live bubble support, Maximo's Calibration module, including mobile technology.
Finally, EDI is one of few services firms who has completely deployed Maximo in the Pharmaceutical market, from concept to go-live, on a global basis. EDI's experience developing GMP workflows and change control procedures brings significant added value to your maintenance efforts.