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Computer System Validation Then & Now; UsingLearning Management in the Cloud

Presented by:Dennis Houser, BSIE, MBA, PMP, Director HR Systems & PayrollHeather Carrillo, MBA, PMP, HRIS Analyst

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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 12 th largest global medical device

manufacturer *170 year heritage

Privately-owned

*out of 150 leading medical device companies as ranked by Clinicas Medtech 1502

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Organization - HR Systems and Payroll

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HR Service Model MAPo Incentive Programs

WellnessState Level Leave

AdministrationOSHA ComplianceContractor Risk ExposureFirst Aid ProgramSafety TrainngNew Project OversightEnvironmental Safety

Exposureo Crisis Management

Disability / WC ManagementReports / Metrics /

Benchmarks / Budget

o RIF Mgmt

Health & Welfare Admin

Open EnrollmentCarrier EnrollmentPremium AdministrationTotal Compensation

StatementsFlexible Spending

AccountsCOBRA/HIPAA

AdministrationPension PlanDependent Audit401k Administration

Vendor MgmtEAPLeave AdministrationOn-Site Health CentersReports / Metrics /

Benchmarks/Budget

Braun Career Centers

Global Job MarketHiring Manager

PortalOnline Sourcing &

RecruitingBackground ChecksDrug TestingI-9 ComplianceStaffing Programs

o External BrandingContingent WorkforceNew Hire BrochurePosition Mgmt / Job

DescriptionsStaffing Plans

o On-BoardingReports / Metrics /

Benchmarks/Budget

o Workforce Planning

Recognition Pgmso Internal BrandingHR AuditCompliancePoliciesEmployee. RelationsInternal client

relationship mgmt Affirmative Action/ EEOEmployee RecordsExit Interview on-line

Unemployment claimsEmployee HandbookOutplacementOff boarding

o Business Need StrategyHR Strategic PlanVerification ServicesEmployee

Communicationso Reports / Metrics /

Benchmarks/Budget

Training & Development

Curriculum

Training Tracking(21 CFR Part 11)

Succession Planning

o OrganizationalDevelopment

o Learning ResourceCenter

o Talent ManagementPerformance

o Successiono Learning Mgmt.System

o Reports / Metrics /Benchmarks/Budget

Payroll

Tax File & ComplyGarnishmentsNew Hire reporting

Application HostingSarbanes-OxleyCompensation MgmtProgression based sysIncentive Compensation

ManagementEmployment Tax Credits21CFR Train Tracking

Empl.Records Imagedo Pay cardsHR Portal (e-Source)

Single Sign OnPaperless Pay & W2Time TrackingTime off requests

AttendancePCNs on lineW4s on lineSpending Accounts

Verification ServicesOpen enrollmentMobile Apps

Reports / Metrics /Benchmarks/Budget

STAFFINGHUMANCAPITALMANAGEMENT

LEARNING &DEVELOPMENT

BENEFITS ADMIN

COMPENSATION,PAYROLL &SYSTEMS

HEALTH &SAFETY

High Priorityo WIP

In Place/OK Future

B.Braun Human Resource Service Model

ActivitiesMessage ActivitiesMessage Activities Activities Activities ActivitiesMessage Message MessageMessage

HR Systems

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Strategies

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Validation Now - CoordinationInvolves coordination of:

Vendor Quality Assurance Change Control Request (CCR) and

protocol reviewData Base Administrator (DBA) & other InformationTechnology(IT) Department resourcesExternal 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 ManagementSystem(TMS) Performance Management, SuccessionManagement 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 toUser 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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Contact Information

Dennis.Houser@bbraun.com

Heather.Carrillo@bbraun.com

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