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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

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 Clinicas Medtech 150
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Organization - HR Systems and Payroll

2008 ADP, Inc. Confidential & Proprietary.

B.Braun Human Resource Service Model

HUMAN
CAPITAL
MANAGEMENT

STAFFING

HR Service Model MAP


Message

Activities

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

Message

Activities

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

LEARNING &
DEVELOPMENT
Message

Activities

BENEFITS
ADMIN
Message

Activities

Training & Development Health & Welfare Admin


Open Enrollment
Curriculum
Carrier Enrollment
Premium Administration
Training Tracking
Total Compensation
(21 CFR Part 11)
Statements
Succession Planning
Flexible Spending
Accounts
o Organizational
COBRA/HIPAA
Development
Administration
Pension Plan
Dependent Audit
o Learning Resource
401k Administration
Center
Vendor Mgmt
EAP
o Talent Management
Leave Administration
Performance
On-Site Health Centers
o Succession
Reports / Metrics /
o Learning Mgmt.System Benchmarks/Budget
o Reports / Metrics /
Benchmarks/Budget

COMPENSATION,
PAYROLL &
SYSTEMS
Message
Message

HEALTH &
SAFETY
Activities

Activities

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

o 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

High Priority
o WIP
In Place/OK
Future

HR Systems
o RIF Mgmt
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Strategies

2008 ADP, Inc. Confidential & Proprietary.

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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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 Procedures
(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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Validation in the Cloud - Process


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Validation in the Cloud - Process

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Validation in the Cloud - Process


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Contact Information

Dennis.Houser@bbraun.com

Heather.Carrillo@bbraun.com

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