Glenn Hodges Darrell Tucker

1
Paperless Computerized Calibration Management
System (CCMS) Implementation

• Glenn Hodges / Darrell Tucker

ISPE Technology ShowDurham, NCMarch 21, 2007
2
Business Challenges Facing Calibration

• Exposure to 483s and Warning Letters due to
  documentation errors within calibration
• gt5 of completed calibrations contain cGMP
  documentation errors
• Need for a validated calibration application
• Calibration-related Investigation resolution
  consumes an average of 30 days
• Average cost of 10,000 per Investigation
• Inconsistent approaches to calibration management
  across sites
• Process calibration procedural differences
• Various out-of-compliance technology platforms
  across sites
• Accessibility of electronic data limited due to
  21 CFR Part 11 issues, multiple incompatible data
  sources, within and across sites, paper-based
  recording and tracking
• Insufficient control of calibration standards
• Inconsistent procedures for identifying ,
  tracking reverse traceability

3
CCMS Project Costs

• Total Cost of Local Site Project
• Project Investment of 1.2 Million
• Third Party Integrator hired to assist in CCMS
  Implementation
• Integrator Cost of approximately 700K
• Developed all Validation Documentation
• SME on Calibration Manager application
• Coordinated executed majority of Validation
  testing
• Data Migration Process
• 8 Data Entry Clerks at a cost of approximately
  100K
• Application Data Import cost of 1.5 K per
  snapshot
• Performed 5 data import snapshots during data
  migration process
• Software / Hardware
• 37 Laptops (33 Regular, 4 Rugged Duty) purchased
  for data entry by technicians, 58,000, plus
  Satellite license cost of 16,650 (37 _at_ 450
  each)
• 50 Site Licenses for Enterprise Application,
  62,500 (50 _at_ 1250 each)
• Report Development Software, 35,000 for
  unlimited license

4
Paperless CCMS Implementation Efforts

• Basic Data
• Imported 7800 instrument records
• Created and imported 7800 Measurement Data
  Templates (MDTs)
• Test points 43,000
• Calibration SOPs
• High Priority 8
• Supporting Job Aids 7
• Low Priority 25
• Training
• Basic Navigation 1 (Core)
• Roles Based 5 roles
• Participants 260
• Identify Super users

5
Paperless CCMS Implementation Efforts (cont.)

• Basic Data
• Validation Documentation
• Core (Validation Plan, URS/FS, Configuration
  Spec., IQ, OQ)
• Site Specific (Validation Plan, URS/FS, Design
  Spec., IQ, OQ/PQ)
• Business Continuity
• Data Migration
• Cut-Over Plan
• Report Design Specification
• Hardware
• Servers Enterprise
• Laptops Site only, 34 regular and 6
  ruggedized
• Recharging stations and extra batteries
• Storage Cabinets

6
CCMS Implementation Results

• Where We Are Today
• 100 Equipment Master / MDT data verification was
  conducted after data migration
• Approximately 1100 scheduled calibrations are
  performed per month
• 98 of calibrations are performed on Satellites /
  Laptops
• Average number of users in local site dataset at
  anytime 20 30
• Total number of active users 250
• Electronic signature approvals required for all
  records
• Use the Select / Sorts to pull those records
  based on Routing Status.

7
What We Learned

• Recommendations / Lessons Learned
• General
• Assigned subject matter experts (SME's) are vital
  to each sites project.
• Provide input on every element
• Time commitments will increase as the project
  progresses.
• Required for all facets of implementation
• Establish attainable schedule
• Review and obtain support / agreement from SME's
  and approvers on overall timeline requirements
• Document review cycles generally must be closely
  monitored
• Resource availability for support will be a
  continuous challenge and has to be constantly
  managed

8
What We Learned (cont.)

• Recommendations / Lessons Learned
• Business Process
• Start Business Process review and development as
  early as possible
• Develop Business Flow Diagrams using roles based
  swim lanes
• Establish site To Be (Core and Site Specific)
• Develop and integrate Electronic signatures
• Identify issues associated with site specific
  processes
• Determine application signature rules (If
  available)
• Create process scenarios of preliminary flows
• Build scenario scripts based on roles,
  responsibilities and e-signatures
• Establish a working environment with working data
• Involve multiple users who will be performing
  business processes for their future roles
• Work in conjunction with SOP development

9
What We Learned (cont.)

• Recommendations / Lessons Learned
• Validation Documentation
• Documentation approvals
• Have designated approvers and alternates
  identified
• Bring site QA in early to get agreement on
  requirements and leveraging
• Build approval times into project schedule
• Leverage documentation from other sites
• Application Help Desk Support
• Application Support Development
• Develop Enterprise Help Support Paths
• Develop Site Specific Application SME Support
  Paths
• Establish Corporate IS/ Site IS / Site
  Application Support Roles

10
What We Learned (cont.)

• Recommendations / Lessons Learned
• GMP Document Development
• Assess type, number and impact of changes to
  current documentation
• SOPs
• Knowledge Checks and Answer Keys for SOPs
• Courses
• Job Aids
• SOP Accelerated Process Model
• Schedule SME Review Meeting, Bring Draft with
  Proposed Revisions and Review Revisions
• Integrate Review Content while developing
  training material in parallel
• Final SME Review and Peer Review in parallel
• Resource Recommendation
• Technical Writer and Administrative Assistant to
  help with word processing and preparation of
  Document Approval Request (or similar) forms
• Single point of contact in Document Control
  identified to the project

11
What We Learned (cont.)

• Recommendations / Lessons Learned
• Data Cleansing and Migration
• Dedicated SME effort
• Review legacy system or paper-based system for
  data improvements
• Identify data that requires normalization
• May become the basis for picklists
• If legacy system not currently validated, begin
  the data cleansing process prior to migration
• Watch for spaces and other editorial input errors
• Perform multiple snapshots to verify data
  conversion into the application
• Consider pick lists types as part of the
  normalization effort
• Fixed, Append, Force Append
• Consider the impact from a data maintenance
  perspective
• Have error checks created for comparison of
  picklist to field data

12
What We Learned (cont.)

• Recommendations / Lessons Learned
• Measurement Data Templates
• Determine if and how MDTs will be used
• One-to-one or one-to-many
• Recommend that a double blind method be used for
  creating new records.
• SME Led-effort
• Hands-on MDT creation or guides data entry effort
• Interpretation of data
• Schedule compliance
• MDT verification
• Conversion of existing data to application
  structure

13
What We Learned (cont.)

• Recommendations / Lessons Learned
• Change Management / Training Considerations
• Identify a Change Management resource early to
  lead the change / training effort
• Develop Training Process Map (Spreadsheet)
• Trainers
• Logistical Considerations and Planning
• Corporate Material and Roles based training
  material has been developed
• Integrate with site SOP development
• Set-up Change Workshops
• Key Communications
• Practice Sessions
• Provide a Help Process

14
What We Learned (cont.)

• Recommendations / Lessons Learned
• Reports
• Define reporting requirements with all
  stakeholders
• SME's
• Super Users
• User groups
• Calibration
• QA
• Path to design
• Establish only the basics in URS
• Begin report technical specifications
• Allows report development process to continue
  without bogging down the design specification
  approval
• Can incrementally approve report design among
  designer and stakeholder
• Establish a set time frame
• Convert to Design Specification for Reports when
  complete
• For validation purposes

15
Paperless CCMS ?