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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Questions