1. Upgrading from Calibration Manager to Blue Mountain RAM
Blue Mountain Summit 2012
Upgrading from Calibration Manager to Blue Mountain RAM

2. Introduction Kevin Grady GMP Technical Solutions
New England based professional services company
Focused on computer systems implementation and validation in the life science industry
Blue Mountain Experience
13 years of experience working with Calibration Manager (CalMan)
5 years of experience working with Blue Mountain Regulatory Asset Manager (BMRAM)
10 BMRAM projects since 2007 2

3. Objectives
Common business cases for justifying the migration from CalMan to BMRAM
Primary differences in functionality between CalMan and BMRAM
Business process enhancement opportunities
Key Focus Points/Lessons Learned 3

4. Why Migrate?
Common business cases for justifying the migration from CalMan to BMRAM
Centralized Management of common activities
Maintenance
Calibration
Validation
Inventory (Spare Parts/Materials) 4

5. Why Migrate?
Common business cases for justifying the migration from CalMan to BMRAM
Efficient and compliant implementation of paperless operations
Calibration execution
PM execution
Unscheduled work execution
Pre/Post work review
OOT disposition
Asset induction 5

6. Why Migrate?
Common business cases for justifying the migration from CalMan to BMRAM
Web Based architecture with Browser Based Client (Internet Explorer)
Increased efficiency
Reduced Validation effort 6

7. Why Migrate?
Primary differences in functionality between CalMan and BMRAM
Asset Hierarchy
Increased Event types/functionality
Calibration
Maintenance
Validation
Training 7

8. Why Migrate?
Primary differences in functionality between CalMan and BMRAM
Increased workflow flexibility
Electronic Signatures
State Management
Notifications
Workspaces 8

9. Why Migrate?
Primary differences in functionality between CalMan and BMRAM
Increased Work Plan management
Job Plans
SOPs/Work Instructions
Significantly higher number of User Defined Fields configurable at the Site, Dataset Level 9

10. Why Migrate?
Primary differences in functionality between CalMan and BMRAM
Increased Measurement Data Template (MDT), Event and Standard engine functionality to support calibration.
Batch Work Generation
Work Records are may be configured to support workflow processes 10

11. Business Process Summary
Business process enhancement opportunities
Define more efficient business processes
Align electronic workflows with desired updated business processes
Data cleansing 11

12. Key Focus Points/Lessons Learned
Asset/Equipment Numbering
Identify a clear path forward that all team members understand and agree to.
Smart Numbers vs. Serialized Numbers
System ID/Component ID vs. Asset ID 12

13. Key Focus Points/Lessons Learned
Communicate decisions to all impacted departments
You may not be the only department that utilizes these identification numbers 13

14. Key Focus Points/Lessons Learned
Asset Hierarchy
Be sure to fully understand the impact of designated Asset Types during migration
Locations/Systems/Equipment/Loops
Asset/Event Duplication
Multiple Data Migration Sources beyond CalMan 14

15. Key Focus Points/Lessons Learned
Business Process Mapping
Don’t be afraid to rethink the way you do business.
Generate the “To-Be” workflows independent of BMRAM
Map your “To-Be” workflows to BMRAM functionality, identifying gaps.
Avoid mapping your “As-Is” workflows from CalMan into BMRAM 15

16. Key Focus Points/Lessons Learned
Effort may be required to support new functionality
Paperless Calibration
MD Templates
Paperless Scheduled Maintenance
Work Plan Templates
Spare Parts Management 16

17. Questions