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©2012 Waters Corporation 1

Simplifying Electronic Document Review and

Approval With WebDynpro and Active

Directory

John Mayhew


Introduction

Challenge to Waters

Problem statement

Solution

Roadmap

Agenda


A partner Yesterday, Today and Tomorrow . . .

Global leader with complementary analytical technologies

Separations Sciences (Liquid chromatography)

Mass Spectrometry

Chemistries

Scientific data management applications

Year founded: 1958

Publicly traded corporation

(NYSE:WAT), $1.8B, 2012 Revenues

Headquartered in Milford,

Massachusetts

Number of Employees: 5,000,

including 2,400-strong sales

and service Personnel in 27 countries


Manufacturing



Pharma &

Biotech - 57%

Industrial, Food &

Environmental - 25%

Academic /

Government - 18%


Core Competencies: A Total Systems Solution Approach


Waters challenge . . .

COMPANY STRATEGY/APPROACH FOR MEETING CUSTOMER’S NEEDS AND HOW WATERS SEE’S ITSELF HAS CHANGED OVER TIME . . .

Discrete component provider

Integrated systems provider

Complete solutions provider

It’s gotten complicated . . .

Waters Design Authority is now Distributed

Major acquisitions are now integrated from an internal PDM

perspective

Global development teams working from the same documents to

govern their product development efforts


Waters challenge . . .

EASY ACCESS TO DOCUMENTS

SIMPLE INTERFACE (anyone can understand)

CONTEXT SENSITIVE User Interface (no one can see

what they can’t do . . .)

“USER CENTRIC’ APPROACH (Favorites, recent items,

easy search, etc.)


The problem for Waters . . .

User credential authentication inconsistent from one environment to another

Senior Management viewed process for R/3 electronic review and approval to be extremely cumbersome

Casual users continually required re-training - R/3 required too many steps to complete a review and approval transaction

Review/approval comment and mark-ups not easily obtained allowing authors to collate and incorporate into originals when necessary


The Solution For Waters . . .

Introduce Active Directory to eliminate credential

authentication issues

Replace R/3 GUI with WebDynpro GUI for Electronic

Document Review and Approval

Replace OOTB R/3 transaction with more intuitive,

flexible and context sensitive transactions


The Solution For Waters . . .

Enable document access for review/approval from

multiple access points

Ensure solution is 21-CFR Compliant with electronic

signature rule

Implement a markup tool that facilitates collation /

incorporation of review/approval comments


A closer look at the Waters Solution (back office)

Document Types and Document Status Networks

Document Type (PRJ / PRX) Project Documents Sub Document Types -MRD (Market Requirements Document) -PRJPLN (Design & Development Plan) -UREQMT (User Requirements) -PREQMT (Product Requirements) -TSTPLN (Test Plan)

Document Type (QAX) Quality Documents Sub Document Types -PROCED(Process and Procedures) -POLICY (Policies) -WINST (Work Instructions)


Author

(UA) Under Approval

Reject Or

Approve

(UA) Under Approval

Reject Or

Approve

(UR) Under Review Review Pass

Or Review Fail


Or Review Fail

Document Status Network

(CP) Concept Check In

(OR) Out For Review


Or Review Fail

(IW) In Work

Check-Out (RC) Review Complete

(OP) Out For Approval

(UA) Under Approval

Reject Or

Approve

Review Fail

Review Pass

(RG) Release General

Approved

Rejected

Start

End



Signature Strategies and Review and Approval Strategy Tables



Signature Strategies and Review/Approval Strategy & Project Tables



A closer look at the Waters Solution (user interface)

Prior to review or approval

Standard R/3 Presentation

WebDynpro Presentation


Review and Approval Agents are displayed




Lotus Notes Notification “Review Action Required”

Note: also available using: -R/3 Inbox -Portal Project Collaboration Rooms -Portal UWL



WebDynpro Presentation

Standard R/3 Presentation



Electronic Signature applied /Comments Entered


Notification of completed reviews

Note: Reviews remain open until “Review By” date is reached. Delinquent reviews force emails indicating review pass due.



Road Map

Improved 2-D Document Viewing & Markup with BRAVA

Integration (Summer 2013)

Integration with multiple authoring environments (IBM’s

Rational Tool Suite (Summer 2013)

Dynamic document approval strategies. (2014)


Roadmap BRAVA Integrated 2-D Viewer/Markup


Roadmap IBM’s Rational (DOORs) Integration

IBM’s Rational DOORs

Key Design Traceability Document Sourcing

Middleware

COM

component (SAPSSOexe)

Calls SAP DIR create Transactions and returns

related metadata

SAP’s Document

Management System

Formal document review and approval


Roadmap IBM’s Rational (DOORs) Integration


Our DMS Platform Solution For Product Development

Review and Approval

Embedded

Markup &

Viewing Tool

BRAVA

Document Management

System

Leveraging common tools provides universal methods for managing documents.

DOORS Authoring Environment

Tool Suite

Change

• Requirements Management • Objective

Evidence • Test Case

Library

• Design Defect Tracking • Test Case Management • Enhancement

Requests

MS Office Authoring Environment

• Plans • Reports • Matrices • Indexes • Certificates • Minutes

Portal Project

Collaboration Rooms/

Document Viewer

Project Room Categories of Folders

• Misc/Ancillary Docs* • WPDP Deliverables • Workflow Deliverables • Optional Deliverables * NOTE: No Review or

Approval required

Doors/SAP Interface

Review and Approval

Access Points

• Portal UWL • Lotus Notes • Project Rooms • R/3 Inbox

Uploaded to & Launched

from Project Room

http://www.bravaviewer.com/experts.htm