Compliance In A Box Documentum Deployment Solution

Compliance-in-a-Box™

Impact Systems, Inc.

Partner:

:

April 11, 2023 Confidential & Proprietary ImpactInfoSys.com

2April 11, 2023 Confidential & Proprietary ImpactInfoSys.com

2

Presentation Outline

1. Compliance-in-a-Box™• Why Compliance-in-a-Box was developed • Compliance-in-a-Box overview and philosophy

2. Compliance-in-a-Box SOP Edition

3. Compliance-in-a-Box Submission Edition



3

Why?

We heard our customers


4

Compliance-in-a-Box™ (CiB)

• Developed specifically to provide an ECM solution for regulated industries in the SMB market, or departments within larger enterprises

• Enterprise content application – jump start ECM with CiB building blocks

• Cost effective, rapid deployment• Methodology based on industry

experience


5

Compliance-in-a-Box™ Philosophy

• Rapid deployment: ready for Production in less than 4 weeks

• Pre-configured, templated solution• Tightly defined project scope and set

of configurations

• Visible, measurable results in a condensed time frame• Embraces Six Sigma principles

(small project with visible and measurable results which lends to continuous improvement)


6

Compliance-in-a-Box™ Philosophy

• Significantly reduced implementation cost with minimal IT involvement

• A scalable application across theenterprise, including geographies

It’s not about technology but successful organizational adoption of technology

Enterprise

What is included in the CiB Offering?

Flexibility to Select Single or Multiple Components

Implementation Services(Configuration Parameters, Validation Framework Templates,

Implementation Check List and Project Plan)

Software Specifications

Hardware Specifications

CiB Implementation Services Approach

Engagement completed in < 30 days

Start End

Implementation Project Plan and Check List

Configuration Parameters +1x use of Configuration Tools

Validation FrameworkTemplates

Best Practice”ImplementationMethodology

A completeset of Validation Documentation ready for sign-off

“Go Live” ReadyImplementation


10

CiB Delivery Options

Purchased Hardware:• Servers pre built and delivered to

the customer site• Customer manages and maintains

Customer’s Hardware:• Tools and ‘Best Practices’ brought to customer• Servers built on customer infrastructure

Compliance-in-a-Box

Compliance-in-a-Box™ SOP Edition

Partner:



13

Challenges

• Versioning • Security model• Review and approval routing• Regulatory agency compliance• Proven, repeatable process


14

Enterprise Elements: Life Sciences example


16

Typical CiB Engagement

• Requirements Definition• Software Installation• Configuration• Validation• ‘Box’ Delivery• Knowledge Transfer• Project Acceptance & Closure


17

Compliance-in-a-Box™ in Use

An International Health Research Institute

• Challenge: The client was in the process of deploying a completely new facility, and needed a way to manage SOPs across the organization. A limited budget was available to accomplish this.

• Solution: The CiB solution was delivered, installed, configured, validated and ready for training in less than four weeks. The customer is planning a phased deployment of EMC Documentum applications. Having CiB in such a short time allowed them to include a system in their design that allows their users a head start in their Documentum Compliance Manager learning curve.


18

Compliance-in-a-Box™ in Use

An International Engineering/Construction Management Company

• Challenge: Evolve from home-grown systems and paper processes to an enterprise application for a very large government project.

• Solution: A fully functional, validated, content-ready Documentum Compliance environment was up and running within weeks, providing the customer with a scaleable enterprise application. The CiB solution provided peace of mind that the most recent versions of critical procedures are being adopted and followed immediately, hence reducing risk. Procedural approval times were dramatically reduced from three to five weeks down to one week.

Compliance-in-a-Box™ Submission Edition

Partner:



20

Challenges

• Regulatory agency/eCTD compliance

• Shorten drug development timelines

• Getting content under control• Legacy content/legal risk• Proven, repeatable process

Discovery & Research Preclinical Clinical Manufacturing Sales, Marketing

& Service

Process Examples• Toxicology Study

Planning• Resource Allocation

Content Examples• Toxicology Reports• Study Definitions• Analysis & Findings• IND Submissions

Process Examples• Batch Content Mgnt• Structured Product

Labeling - PIM• CAPA• SOP Management

Content Examples• GMP Manufacturing

& Quality Mgnt• Labeling

Process Examples• Contracts Mgnt• Marketing Resource

Mgnt• Web Content Mgnt

Content Examples• Promo Materials• Packaging• Web Site Content

Process Examples• R&D Collaboration• Formulation Mgnt• Protocol / Methods

Management

Content Examples• Disease Condition

Research• Lead Compounds

Process Examples• eTrial Master File• Studies Management• eCase Report Form• eCTD – Regulatory

Submissions

Content Examples• Clin Study Reports• NDA Submission• Study Tagging Files• Trial Materials• Trial Results

Everything must be documented and almost everything must be published

• As of January 1, 2008, companies filing electronic submissions with the U.S. FDA (Food and Drug Administration) must use eCTD format.

• The EMEA (European Medicines Agency) and several individual member health authorities have made similar claims. All member state authorities are expected to accept eCTD by 2009.

Enter the eCTD – Electronic Common Technical Document: International Standard for Submissions to Regulatory Agencies

Challenges with the eCTD

• The eCTD is complex.• The eCTD will drive internal process change.• Electronic document management and eCTD submissions

are often treated as completely separate processes.• Technology solutions - content management and electronic

submission systems - historically have been too expensive for Tier II and Tier III Life Sciences companies.

eCTD Business Impact

• Increased time to market• Inefficient, high cost processes• Increased risk of non-compliance• Increased risk of litigation

The Solution?

• Compliance-in-a-Box Submission Edition

• Best of Breed Solution Set from EMC, ISI and Impact Systems


26

What is included in the CiB SE offering?

Documentum Compliance Manager (DCM)

+

Leading Regulatory Submission and Publishing Tools from ISI

+ Pre-configurations, documentation templates,

validation scripts and implementation services from Impact Systems

Process Templates, Pre-configuration Tools and Best Practices for Optimized Deployment

Compliance Interface

Process Services

Content Services

Repository Services

Documentum Compliance

Manager

Virtual Link Manager

EMC Documentum Platform

ISIPublisher

eCTDXPress

Compliance-in-a-Box Submission Edition


28

In Summary: CiB Highlight of Features

• Rapid deployment• Hardware and software come fully

validated ready for content• Includes FDA/OQ reports, optional PQ with

training on request

• Allows for easy upgrades and add-ons• Provides an infrastructure that can scale as your organization

grows

• Additional solution features• Includes a wide range of additional features, available

customizations, services and software tools

• Requires less money up front• Create a monthly payment plan over an extended period


29

Why CiB?

• Best in class: developed jointly by EMC® Documentum and Impact Systems

• Flexible building blocks to accommodate your needs and priorities:• SOP, submissions, batch records,

CAPA, forms, labels, etc.



30

Why Impact Systems?

• 6 years as an EMC Documentum Select Services Partner

• 11 years ECM experience• Comprehensive deployment and

migration experience• Proprietary software tools

• Q-Config™: Configuration deployment, management and migration software

• Q-Transfer™: Bulk data content transfer software• Q-Scripts™: System validation framework



31

Thank you for your time.

For More Information:

www.impactinfosys.com

[email protected]

302.573.6864 x105

http://www.impactinfosys.com/

mailto:[email protected]

Compliance In A Box Documentum Deployment Solution

Business

Transcript of Compliance In A Box Documentum Deployment Solution