Documentum for Quality and Manufacturing Key Features … · • Sets of related documents are often sent to the same Reviewers and Approvers. ... integration between TrackWise and

1 © Copyright 2016 Dell . All rights reserved. 1 © Copyright 2016 Dell. All rights reserved.

Documentum for Quality and Manufacturing Key Features and Integrations

Jessica Kelley, DellEMC

2 © Copyright 2016 Dell . All rights reserved.

Documentum in Life Sciences


Documentum in Life Sciences Documentum has been the Life Sciences industry’s leading content

management platform for over 20 years.

© Copyright 2016 EMC Corporation. All rights reserved.

100% 78% 90%

of the top 10 Pharmaceutical

companies use EMC Documentum

of the top 50 Pharmaceutical

companies use EMC Documentum

of the top 10 Biotech companies

use EMC Documentum


Since 2012, D2 and our D2 based Life Sciences Solutions have seen wide adoption in the Life Sciences Industry. Customers have selected D2 Life Sciences Solutions because…

D2 in Life Sciences

• Personalized user experience

• Functional agility via flexible configuration

• Predefined industry best practice configurations

EMC’s Life Sciences Solutions are based on the D2 Platform


Documentum for Life Sciences Solution Suite


Pre-configured solutions • Launched 4 solutions

spanning clinical, regulatory and quality since 2012

• Built to reflect industry guidance, best practices and 25+ years of life sciences experience

Life Sciences Investment and Growth

High growth & profitable • High growth investment

area for the division

• Strong R&D investment

• Profitable product line

Strong investment • Hired dedicated Life

Sciences industry veterans & subject matter experts across product, pre-sales & sales

• Acquired Sitrof in 2013 to bolster global professional services in Life Sciences

2012 2016


Documentum D2: Modern UI and Flexible Business Rules

DOCUMENTUM: Proven Compliant and Scalable Platform

eTRIAL MASTER FILE

Trial Master File

Clinical

Property Registration Security Models Lifecycles and Workflows Compliance Features

RESEARCH & DEVELOPMENT

Quality

Clinical and Safety

Regulatory, Labeling, and Ad/Promo

Nonclinical

QUALITY CLINICAL

UNIFIED SOLUTION LAYER

SUBMISSION STORE & VIEW

Regulatory Correspondence

Regulatory Submissions

QUALITY & MANUFACTURING

Manufacturing

Procedural

Quality

Medical Device DHF DMR

REGULATORY

Change Request Medical Device Clinical and Regulatory

RPS: Retention Policy Services and Records Management

Document Inventory


Quality and Manufacturing Solution Key Features


Industry Leading Document Taxonomy

Document Categories Document Groups Governance and Procedures Directive, Guideline, Policy, Quality Manual, SOP,

Form, Work Instruction

Manufacturing Specification, Method, Master and Executed Manufacturing, Quality, Records and Certificates

Facility and Organization Drawings, Facility Records and Certificates

Packaging and Labeling Packaging and Labeling

Validation Master and Executed Validation (Product, Substance, System and Equipment)

Reference and Training Manuals, Guides, Training Content

Project Documents Project Plans, Risk Assessments, Reports

Change Request Change Request

• Aligns with industry standards and benefits from lessons learned

• Served as basis for DIA Standard EDM Reference Model for Quality Systems

• Granular taxonomy and attributes significantly reduces implementation time

Document inventory and attributes

• Link to DIA GMP Quality Systems Standard EDM Reference Model http://edmrefmodel.com/submission-reference-models/gmp-quality-reference-model/

http://edmrefmodel.com/submission-reference-models/gmp-quality-reference-model/

http://edmrefmodel.com/submission-reference-models/gmp-quality-reference-model/


Multiple Document Workflow • Sets of related documents are often sent to the same Reviewers and Approvers.

Reviewing and Approving each document individually can impact efficiency and system usability.

• Workflow initiators can add multiple documents to the same workflow. Workflow participants can apply a single outcome to all documents in the workflow task in one step.


Controlled Content Templates • When creating controlled

documents from a template, the system should enforce the use of current, Approved templates.

• Dedicated template author and approver groups create new templates and transition them to a major version and Approved status via an approval workflow.


Enhanced Collaborative Editing and Reviewing

• When collaborating on the authoring or reviewing of a document, users should be able to see the edits and comments that have already been added by others in the workflow.

• By selecting “Review and Edit Consolidated Copy” the system will merge all of the tracked changes and comments of the prior authors/reviewers into a single copy which can then be updated by the current author/reviewer.


Change Request Virtual Document Multiple documents are often impacted by a single change request.

Viewing and tracking the progress of the CR and its associated documents can be challenging.

The virtual document structure helps to enforce business rules and allows the user to easily add documents to the CR.


Automated Periodic Review Workflow

Many controlled documents must undergo a periodic review to help ensure accuracy and applicability.

The risk of exceeding periodic review due dates can be reduced with the use of automated workflow initiation and the ability to monitor workflow progress.


Technical Transfer

Pharmaceutical Development

Technology Transfer

Commercial Manufacturing

Product Discontinuation

GMP Investigational Products

DCTM R&D DCTM eTMF DCTM Q&M

Included in submissions (Module 3) • Specifications • Test Methods • Manufacturing Processes • Stability documents • Labelling documents

Used in manufacturing operations • Specifications • Test Methods • Manufacturing Processes • Stability documents • Labelling documents

Notify of change

Traceability


Technical Transfer The technical transfer feature allows users with access to ‘transfer’

documents between the R&D module and the Q&M module via a menu option

– The content of a source document is copied to a new target document – A relationship is automatically created between both the source and

target documents – Metadata is copied bidirectionally between source and target copies to

ensure traceability – Notifications are automatically established to inform key stakeholder

groups if either source or target document changes state


Retention Policy Services EMC’s Retention Policy Services product is now included and certified

in our base Life Sciences Suite

No additional cost – Helps organizations comply with legal and regulatory requirements – Applies and enforces retention and disposition policies automatically – Alleviates compliance burden on end-users – Provides cost savings for storage, compliance and eDiscovery – Built on EMC Documentum Platform


Retention Policy Services Retention policies can be configured to apply when a specific activity

occurs, such as the status change to Withdrawn or Expired.

A retentions widget displays the policy details.


Medical Device in Q&M A complete document inventory,

property pages, attributes and data dictionaries were added to Q&M V4.1 to support the creation and maintenance of

– Design History File (DHF) – Device Master Record (DMR)

The DHF and the DMR are both virtual documents with sections and indexes


Controlled Printing

Functional Capabilities: – Perform controlled prints to both internal and external

recipients – Perform multiple controlled prints in a single action – Perform full or partial reprints of a controlled copy – Manual and automated print recalls – Search and report on controlled copies, reprints and recalls

Configurable Capabilities: – Define document types and statuses available for

controlled printing – Create unlimited print profiles and assign them to different

document types – Add and/or remove triggers for automated recall workflows

Controlled Print Reporting

Benefit: Meets compliance requirements while increasing flexibility and improving usability


Quality & Manufacturing Product Extensions

Value Added Integrations – TrackWise Quality Management System – Learning Management System – SharePoint


Ongoing Area of Focus - Q&M Product Extensions

Documentum for Q&M is only one portion of a customer’s ‘total quality solution’, this solution typically includes:

– Electronic Document Management System (EDMS – eg. DCTM Q&M) – Electronic Quality Management System (eQMS – eg. TrackWise) – Learning Management System (LMS - eg. ComplianceWire) – Shared Internal Portal or Fileshare (SharePoint)

The Life Sciences solutions roadmap includes ‘plug and play’ integrations as a key area of focus

– Companies have traditionally had to live with disconnected systems or develop and maintain costly, custom integrations

Fully supported, off the shelf integration products allow our customers to easily and seamlessly integrate Documentum with other best in class and market leading systems


Synapsys™ For seamless integration of Documentum and TrackWise


Synapsys™ by Impact Systems

• EMC, Sparta Systems and Impact Systems partnered together to design and develop Synapsys, a productized and certified integration between TrackWise and Documentum.

• Impact Systems is a preferred partner with 19+ years of experience in Documentum Technology

• Fully equipped data center in Wilmington, DE (for POCs and managed support services)

• Global Implementation & Migration Services capability & Track Record


Synapsys™ Architecture and Approach

Synapsys™ is a Standalone S/W Application Synapsys™ uses out of box QualityConnect and Documentum

Foundation Services to integrate the two systems Synapsys™ is configured during Implementation for business

use cases


• Searching for documents that are impacted or referenced by a quality record

• Linking documents to a quality record • Creating quality records based on activities in the EDMS • Changing the status of a quality record based on activities in the

EDMS • Bidirectional exchange of data field/attribute values

Key EQMS, EDMS Integration Functionality


TrackWise Grid (Example)

• Reference Documents

• Impacted Documents


Proficio™ For seamless integration of Documentum and a Learning Management System (LMS)


Proficio™ by Impact Systems

Achieves Training Requirements and Standards Compliance

Real Time Communication

Configuration Flexibility

Eliminates Manual Upload and Content Processing

Reduces Risks and Errors

Integrates as Widget within D2 Workspace, Custom Menu Item within DCM or WebTop, or as Standalone Application

Create Configuration Profiles for Business Rules:

Define What Will Be Published


Proficio Functionality • LMS Publishing Manager Dashboard with Scheduled Audit Synchronization

• Displays Published Training Items

• Updates Status of Training Items in the Learning Management System

• Provides Trainee Specific Audit / Training Completion Details and Statistics


SPA4D For seamless integration of Documentum with SharePoint


SPA4D by Informed Consulting

• “SPA4D”

• Developed by Informed Consulting

• Certified by EMC and available

• Enables the use of the SharePoint UI for many D2 functions


SPA4D – Browse Documents

• Provide users and partners access to various document types

• Provide and display content following Documentum security rules specific to each user or external partner

• Leverage MS office and Office365 collaboration functionality

• Ability to see effective or approved documents specific to your users or partner’s needs


SPA4D – Browse Properties


SPA4D – View and Complete Tasks


SPA4D – Search


Watch this space…. Additional integrations and certified solutions are in progress and on the Q&M roadmap!


Quality and Manufacturing Solution Roadmap


• This presentation contains “forward-looking statements” as defined under the US Federal Securities Laws.

• Dell EMC makes no representation and undertakes no obligations with

regard to product planning information, anticipated product characteristics, performance specifications, or anticipated release dates (collectively, “Roadmap Information”).

• Roadmap Information is provided by Dell EMC as an accommodation to the recipient solely for purposes of discussion and without intending to be bound thereby, and is subject to change without notice.

• Roadmap information is Dell EMC Confidential Information, and is provided under the terms, conditions and restrictions defined in the Dell EMC Non-Disclosure Agreement in place with your organization.

Safe Harbor Disclaimer


Q&M Roadmap Priorities R&D and Q&M Product harmonization

Addition of Quality Management document inventory and attributes

Document distribution feature (automated TBR)

Addition of Change Request supporing documents as nested vdoc

Option to drive Effectivity and Withdraw status changes from Change Request

Required and audited reason for any metadata change on Approved and Effective documents

Automatically generated index for DHF and DMR virtual documents

Issued Print

Certified ERP (SAP) Integration


Document Distribution (Automated Training)

Adherence to GMP regulations requires that certain documents be distributed to relevant users and that users sign off that they have read and understood

The process and reports must be inspection ready and are often included in audits

The process can include several thousand documents and users

Many customers currently have groups managing the process with Excel spreadsheets

– Users are grouped into organizations and roles – Documents are assigned by organization and role

These current practices subject the organization to increased cost, time, error and compliance risk


Document Distribution (Automated Training)

This new feature will provide the ability to: – Assign users to specific distribution groups

▪ Company ▪ Department ▪ Role

– Assign individual documents to distribution groups – Automatically assign training and re-training tasks based on

document status changes and addition of new users – Create detailed document and user training reports


Issued Printing Issued Printing is a form of controlled print used primarily for issuing

copies of master batch records to specific production orders.

An issued print feature would leverage much of the controlled print functionality but would include these additional features:

– Ablity to compile virtual documents and to print as a single copy – QA approval of the print – Ability to include a barcode – Ability to cancel, but not recall, a print – Ability to track the status of the print – Reconciliation of the executed batch record with the issued copy


A marketplace of secure content apps that drive end user productivity built on a modular cloud native platform.


Content exchange without the chaos

Enterprise-class capture made for

everyone

Anywhere, anytime access to

your content

Collaborative document authoring with control

Document reader designed for mobile

CONCERT COURIER SNAP EXPRESS FOCUS

LEAP Apps


Immediately integrated with D2 Life Sciences Readily respects D2 configured workflows, lifecycles and security models

New UI, but same D2 and Documentum platform

Improves efficiency for workflow completion Quickly review and approve documents from anywhere, eliminating delays in approving documents

Best-in-class UX Minimal training required

Users delighted to approve and access controlled documents

Available for both mobile devices and desktop browsers

EXPRESS Anywhere, anytime access to your content

A lightweight app to quickly access, review and approve all your content, no matter where it lives


Life Sciences Express A LEAP application that provides a streamlined, business relevant user

interface into the D2 based LS Solutions for the Daily User


Workspace


View Task: Single Document

Document displayed here


View Task: Multiple Document

Document displayed here


View Task: Virtual Document


BETTER TOGETHER

We take content seriously. Leave no application data behind.

© Copyright 2016 Dell . All rights reserved.

Content apps for the digital era.


ENERGY & ENGINEERING LIFE SCIENCES HEALTHCARE FINANCIAL SERVICES PUBLIC SECTOR

COMMUNICATE TRUST PROCESS CONTENT CAPTURE

DECOMMISSION OPTIMIZE ANALYZE CONTROL

Private Cloud

Public Cloud

Hybrid Cloud

Documentum as a Service InfoArchive as a Service

CONCERT COURIER SNAP EXPRESS FOCUS


Be Sure To…. Look for pink ribbons on name badges

(indicating Life Sciences)

Attend the Life Sciences User Group Breakfast

– Wednesday, 7:15am – 8:15am – Fairmont Hotel, Marenostrum B

Visit the Life Sciences demo station in the Momentum booth

Attend a Hands on Lab (D2, Leap Apps)

Visit our partners’ booths!

Schedule a 1:1 meeting with a Genius

Stop by the Momentum Lounge


Tuesday - Life Sciences Sessions Time Presentation Title Speakers

9:00 – 9:45 am Room H2, Garden Level

How CSL Behring Unified Regulatory Processes in Life Sciences Across 3 Continents

Becky Thompson, CSL Behring Frank D'Entrone, fmeAG Yelena Shafir, Product Manager, Life Sciences Regulatory Solutions, Dell EMC

10:00 – 10:45 am Room H2, Garden Level

Documentum for Quality and Manufacturing Key Features and Integrations

Jessica Kelley, Product Manager, Life Sciences Quality Solutions, DellEMC

3:15 – 4:00 pm Room H2, Garden Level

Supporting the Full GxP Domain for Quality Management and Partner Exchange with SharePoint

Jeroen Jansen, Informed Products

4:15 – 5:00 pm Room H2, Garden Level

DSM's experiences on Implementing a Validated Enterprise Content Management Solution

Matty Westveer, Project Director, DSM Dirk Willems, Technical Specialist, DSM


Wednesday and Thursday - Life Sciences Sessions Time Presentation Title Speakers

10:45 – 11:15 am Room A, Garden Level

Roche’s eTMF Journey – A customer perspective

Saju Sadasivan, Business Solution Manager - Pharma Informatics, Roche Adam Kelch, Sr. Product Manager, Documentum Clinical Solutions, EMC (TBD)

11:45 am – 12:30 pm Room A, Garden Level

Enabling Digital Transformation in Controlled Environment in Menarini

Eugenio Capasso Corporate Director for Organization Development and ICT

1:45pm – 2:30 Room F, Garden Level

Documentum for Life Sciences Solution Suite and LEAP: Vision, Strategy, and Roadmap

Jennifer Wemstrom, Sr. Director Product Management, EMC

9:00 –9:45 am Room A, Garden Level

Migrating to the EMC Documentum for Life Sciences solution suite – Processes, Steps and Challenges

Kirstin Dreyfürst, Principal Consultant, FME AG Frank D'Entrone, U.S. President, FME


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