This session from the Institute of Validation Technology's 14th Annual CSV Conference looks at B. Braun’s journey in moving from an in-house validated training tracking system to learning management in the cloud.

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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