computer system validation then and now — learning management in the cloud

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

CSV Presentation |

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


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 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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Contact Information

[email protected]

[email protected]

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computer system validation then and now — learning management in the cloud

Health & Medicine