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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.
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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
CSV Presentation | Page
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 1502
©2008 ADP, Inc. Confidential & Proprietary.3
Organization - HR Systems and Payroll
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HR Service Model MAPo Incentive Programs
Wellness
State Level Leave
Administration
OSHA Compliance
Contractor Risk Exposure
First Aid Program
Safety Trainng
New Project Oversight
Environmental Safety
Exposure
o Crisis Management
Disability / WC Management
Reports / Metrics /
Benchmarks / Budget
o RIF Mgmt
Health & Welfare Admin
Open Enrollment
Carrier Enrollment
Premium Administration
Total Compensation
Statements
Flexible Spending
Accounts
COBRA/HIPAA
Administration
Pension Plan
Dependent Audit
401k Administration
Vendor Mgmt
EAP
Leave Administration
On-Site Health Centers
Reports / Metrics /
Benchmarks/Budget
Braun Career Centers
Global Job Market
Hiring Manager
Portal
Online Sourcing &
Recruiting
Background Checks
Drug Testing
I-9 Compliance
Staffing Programs
o External Branding
Contingent Workforce
New Hire Brochure
Position Mgmt / Job
Descriptions
Staffing Plans
o On-Boarding
Reports / Metrics /
Benchmarks/Budget
o Workforce Planning
Recognition Pgms
o Internal Branding
HR Audit
Compliance
Policies
Employee. Relations
Internal client
relationship mgmt
Affirmative Action/ EEO
Employee Records
Exit Interview on-line
Unemployment claims
Employee Handbook
Outplacement
Off boarding
o Business Need Strategy
HR Strategic Plan
Verification Services
Employee
Communications
o Reports / Metrics /
Benchmarks/Budget
Training & Development
Curriculum
Training Tracking
(21 CFR Part 11)
Succession Planning
o Organizational
Development
o Learning Resource
Center
o Talent Management
Performance
o Succession
o Learning Mgmt.System
o Reports / Metrics /
Benchmarks/Budget
Payroll
Tax File & Comply
Garnishments
New Hire reporting
Application Hosting
Sarbanes-Oxley
Compensation Mgmt
Progression based sys
Incentive Compensation
Management
Employment Tax Credits
21CFR Train Tracking
Empl.Records Imaged
o Pay cards
HR Portal (e-Source)
Single Sign On
Paperless Pay & W2
Time Tracking
Time off requests
Attendance
PCNs on line
W4s on line
Spending Accounts
Verification Services
Open enrollment
Mobile Apps
Reports / Metrics /
Benchmarks/Budget
STAFFING
HUMAN
CAPITAL
MANAGEMENT
LEARNING &
DEVELOPMENTBENEFITS
ADMIN
COMPENSATION,
PAYROLL &
SYSTEMS
HEALTH &
SAFETY
High Priority
o WIP
In Place/OK
• Future
B.Braun Human Resource Service Model
ActivitiesMessage ActivitiesMessage Activities Activities Activities ActivitiesMessage Message MessageMessage
HR Systems
©2008 ADP, Inc. Confidential & Proprietary.5
Strategies
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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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Validation Now - Process
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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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CSV Presentation | Page
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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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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Validation in the Cloud - Process
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