The document discusses the evolution of computer system validation and the integration of cloud-based learning management systems at B. Braun Medical Inc. It highlights the company's extensive human resource service model and the importance of coordination between various departments for successful validation in the cloud. Key concerns and risk mitigation strategies are detailed, including vendor audits and the validation process for new features.

1. Computer System Validation Then & Now; Using
Learning Management in the Cloud
Presented by:
Dennis Houser, BSIE, MBA, PMP, Director HR Systems & Payroll
Heather Carrillo, MBA, PMP, HRIS Analyst

2. Company Overview - B. Braun Medical Inc.
 Headquarters: Bethlehem, PA
 Established in 1957
 Production Facilities
• Allentown, PA
• Carrollton, TX
• Irvine, CA
• Santo Domingo, DR
 Member of B. Braun Group
• 12th largest global medical device
manufacturer*
•170 year heritage
• Privately-owned
*out of 150 leading medical device companies as ranked by Clinica’s Medtech 150
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3. Organization - HR Systems and Payroll
3 ©2008 ADP, Inc. Confidential & Proprietary.

4. B.Braun Human Resource Service Model
HUMAN COMPENSATION,
LEARNING & BENEFITS HEALTH &
STAFFING CAPITAL PAYROLL &
DEVELOPMENT ADMIN SAFETY
MANAGEMENT SYSTEMS
Message
HR Service Model MAP
Message Activities Message Activities Message Activities Message Activities Message Activities Activities
Braun Career Centers o Workforce Planning  Training & Development Health & Welfare Admin  Payroll o Incentive Programs
Global Job Market  Recognition Pgms Curriculum Open Enrollment Tax File & Comply  Wellness
Hiring Manager o Internal Branding Carrier Enrollment  Garnishments  State Level Leave
Portal  HR Audit  Training Tracking Premium Administration  New Hire reporting Administration
 Compliance Total Compensation Application Hosting
Online Sourcing & (21 CFR Part 11)  OSHA Compliance
Statements Sarbanes-Oxley
Recruiting  Policies  Succession Planning  Contractor Risk Exposure
 Flexible Spending  Compensation Mgmt
Background Checks  Employee. Relations  First Aid Program
Accounts  Progression based sys
 Drug Testing  Internal client o Organizational COBRA/HIPAA  Safety Trainng
 Incentive Compensation
 I-9 Compliance relationship mgmt Development Administration  New Project Oversight
Management
 Staffing Programs  Affirmative Action/ EEO Pension Plan  Environmental Safety
 Employment Tax Credits
o External Branding  Employee Records o Learning Resource Dependent Audit Exposure
401k Administration  21CFR Train Tracking
 Contingent Workforce  Exit Interview on-line Center o Crisis Management
Vendor Mgmt  Empl.Records Imaged
 New Hire Brochure  Unemployment claims  Disability / WC Management
EAP o Pay cards
 Position Mgmt / Job Employee Handbook o Talent Management  Reports / Metrics /
 Leave Administration  HR Portal (e-Source)
Descriptions  Outplacement  Performance Benchmarks / Budget
 On-Site Health Centers  Single Sign On
 Staffing Plans  Off boarding o Succession
 Reports / Metrics /  Paperless Pay & W2
o On-Boarding o Business Need Strategy o Learning Mgmt.System Benchmarks/Budget
 Time Tracking
 Reports / Metrics /  HR Strategic Plan
 Time off requests
Benchmarks/Budget  Verification Services o Reports / Metrics /
 Attendance
 Employee Benchmarks/Budget
 PCNs on line
Communications
 W4s on line
o Reports / Metrics /
 Spending Accounts
Benchmarks/Budget
 Verification Services
 Open enrollment
 Mobile Apps
 Reports / Metrics /
Benchmarks/Budget
 High Priority
o WIP
 In Place/OK
• Future
HR Systems
o RIF Mgmt
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5. Strategies
5 ©2008 ADP, Inc. Confidential & Proprietary.

6. Validation Now - Coordination
Involves coordination of:
 Vendor
 Quality Assurance – Change Control Request (CCR) and
protocol review
 Data Base Administrator (DBA) & other Information
Technology(IT) Department resources
 External consultant
 Plant downtime notification & coordination
 Approver signatures
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7. Validation Now - Process
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8. Validation in the Cloud - Key Concerns
• Loss of control
• Addition of features/functionality
• Release dates
• Vendor Provided User Guide – on-line
• 21 CFR Part 11 Compliance
• Interfaces with Document Management System(DMS) and
Human Resources Management System (HRMS)
• Multiple modules involved in Talent Management
System(TMS) – Performance Management, Succession
Management and Learning Management, +
• Benchstrength – HRIS, IT, Quality
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9. Validation in the Cloud - Risk Mitigation
• On-site Vendor Audit performed by Quality and Subject
Matter Expert (SME)
• Added vendor to approved vendor listing
• Operational Qualification(OQ) will include Traceability to
User Requirements Specification(URS)
• Configuration Specification
• Development of Quality Agreement
• Access to vendor Standard Operating Procedure’s
(backup, recovery, etc)
• Participation in User Groups
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10. Validation in the Cloud - LMS
• Vendor responsible for core functionality testing
• We will perform validation/testing for only new
features/functionality that we plan to turn on
• Testing/Validation to occur during User Acceptance
Testing(UAT)
• CCR will be opened for each release
• No validation will be done on bi-monthly patches unless it is a
bug/fix we specifically requested or encountered
• Requalification of vendor per internal procedure requirements
• Vendor development of Validation Toolkit
• Perform full validation for implementation and major releases
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11. Validation in the Cloud - Process
4
1 2 3
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12. Validation in the Cloud - Process
1 2
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13. Validation in the Cloud - Process
3
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14. Validation in the Cloud - Process
4
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15. Contact Information
Dennis.Houser@bbraun.com
Heather.Carrillo@bbraun.com
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