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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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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 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
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