DOLSR SubmissionOpenText Life Science Suite

dedicated to support submissions

M Y N A M E I SED STEENHOEKMANAGER BUSINESS SOLUTIONS

CONNECTING PEOPLE

TO THE ENTERPRISE

ENTERPRISE

INFORMATION

MANAGEMENT

If technology were driving on the highway, it would probably

get a speeding ticket but that is not my main concern.

Technology is moving at a speed that, even when looking

at its relative instead of absolute change, we have not seen

before. This faces regulators with a challenge: how to keep

regulations in sync with the ever growing possibilities that

technology exposes. Compare this with the fact that it was

not too long ago that submissions were done on paper.

We live in an age where digital is the new normal. Moving

from paper submissions to the electronic equivalent was

a step along the lines of normal progression. Knocking on

our door are technologies that skips progression and jump

straight in disruption. Time will tell if this will be next year or

need another one or two years from now.

The complex structure of an eCTD is one of the candidates

to become victim of that disruption. It might not be for the

faint-hearted, but in due time, a submission is a collection

of data with some machine learning or artificial intelligence

around it.

We are on the brink of business solutions that will ‘read’

all your documents, match it against predefined checks

and questions and present a package to the regulator.

A package containing (references to) the unstructured source

information, evidence of the checks and questions being

answered and a report with a summary and some highlights

and/or low-lights will be made available for regulators.

Too far off? Maybe. But machines are so much better at

consuming these huge data collections and identifying

omissions, inconsistence and unfounded conclusions.

It is only a matter of time. I will agree that today it still is to

early to give an accurate prediction.

For now, we will continue our processes as they are. But be

prepared for the laughter at a birthday party when granddad

tells stories from his working career that feels like you’re

‘driving’ a horse and carriage when going to work.

Technology is Speeding compared to Regulations and Adoption

Jeroen Jansen, CEO

Ed SteenhoekManager Business Solutions AIIM Certified Information Professional Member of the AIIM Leadership Council

Research & Development Submission, Store & View

Collaborative Edit Compliance

Documentum for Research and Development helps eliminate redundant, manual data entry activities and improve the accuracy of submission-ready content. To achieve this, it includes dictionaries, taxonomies and object models leveraging the DIA EDM reference model.

Documentum Submission Store and View enables you to move submission files off uncontrolled file shares into a secure, compliant Documentum repository. Additionally, the ability to set access controls, password strength, and log-in attempts, further strengthens your compliance.

Collaborative Edit enables working simultaneously in the same document with real-time updates of edits or comments made by co-authors and co-reviewers improves quality and efficiency. No need to reconcile individual changes afterward. Ready to support both internal and external users.

With Documentum for Research & Development,organizations can clearly prove 21 CFR Part 11 compliance with extensive audit trails and access controls, including e-approval and e-signature support, document distribution, version control and lifecycle management.

eCTD ManagereCTDmanager provides you with a complete regulatory dossier management and assembly solution. Its scalable, all-in-one submission management capabilities meet the requirements for both electronic (like eCTD) and paper submissions.

ExpandableBecause no Documentum implementation is the same, it is possible to expand DOLSR Submission to neatly fit any environment. Other modules of the Life Science suite can be added or other products (e.g. Informed Products’ Collaborative Partner Exchange) can be added.

What are the characteristics of DOLSR SubmissionDOLSR CMO is a business solution that leverages the technical capabilities of 4 products. The main part is the Research & Development module of OpenText Documentum for Life Sciences,. This is enhanced with their Submission, Store and View module from the same suite. Another key component is the eCTD Manager from Extedo. This is complemented with Informed Products’ Collaborative Edit for real-time collaborative editing and reviewing of documents.

R&D and SSV modulesHow to benefit from the

OpenText™ Documentum™ for Research and Development accelerates the regulatory submission process by efficiently managing the creation, review and approval of regulatory submission documentation. Users will not only speed up the submission process, but also benefit from uncompromised compliance, complete global control of content and secure information sharing across the extended enterprise.

OpenText Documentum Submission Store and View, part of the OpenText Documentum for Life Sciences, simplifies the search and retrieval of archived submissions and their associated correspondence, while improving security and compliance. The solution links regulatory correspondence and communications to submission files, enabling a full view of regulatory activity.

Research & Development feature chartCompliant document creation

Easily assemble submission content for pharmaceutical and medical device products using controlled templates with predefined inheritance rules and metadata based on industry leading practices.

Collaborative authoring, editing and reviewAllow multiple contributors to co-author documents with real-time, simultaneous authoring and editing of document content using the standard “track changes” functionality of Microsoft® Word®

Search and retrievalQuickly find submission-related documentation using faceted navigation to automatically reduce the document list, reflecting only relevant results. This boosts productivity and increases content and metadata reuse.

Compliance with real-time visibilityLeverage access control, detailed audit trails, e-approvals and e-signatures to easily meet compliance. Answer questions about progress and readiness with “where used” reports and gain insight on day to day performance of applications around the globe.

Link content throughout drug lifecycleSupport full product lifecycle with a common data model. No manual intervention is required to share documents from the early development phase through to clinical trials and submissions to product.

• Store regulatory submissions and associated communications in a compliant and secure repository

• Import submissions in eCTD, NeeS, or paper formats

• Easily access and view regulatory correspondence linked with submissions

• Quickly search and retrieve archived submissions and associated documents

• Streamline Electronic Common Technical Document (eCTD) viewing

• Automatically query and suggest applications to include during instances of Grouped Variations/Submissions

Submission, Store & View

The modularity of the DOLSR platform will help you meet your needs

DOLSR Submission both a full business solution and extendable subset of DOLSRDOLSR is a business solution for organizations in the life science industry. In the basis it is the OpenText Life Sciences industry solution which is a pre-configured instance of Documentum D2.This industry solution contains 4 main modules: eTrial Master File (eTMF) in the clinical domain. Research & Development (R&D) and Submission Store & View (SSV) in the regulatory domain and Quality & Manufacturing in the quality domain.With DOLSR, this quality domain is enhanced with a quality management (QMS) module called EQMS Express. This module leverages the full data model

that comes with the Life Sciences industry solution, reduces the need for a custom integrating with a 3rd party solution and provides all the benefits from the underlying D2 application.

With DOLSR comes the ability to add specific benefits from the Microsoft Office 365 / SharePoint platform.

With Collaborative Edit, DOLSR offers true synchronous editing and reviewing of Microsoft Office documents under control of Documentum but with the flexibility and easy of use that Microsoft offers.

With Collaborative Partner Exchange, DOLSR offers the possibility of working with partners/ customers in a controlled environment without the risk of inserting content that doesn’t meet your quality standards.

With LMS365, DOLSR offers a full Learn Management solution that supports simple TBR tasks up to the full management of role specific curriculums and the certifications that come with it.

When need, it is also possible to integrate DOLSR with the eCTDManager from Extedo.

Why Choose For

Informed Group

Our mission is about building bridges between business processes and users: Connecting People to the Enterprise

Visit www.informedgroup.com for more information about our products and blog posts of our consultants.

Added value is created from experience and educating ourselves during internal research and many conferences.

AIIM Leadership Council EMEA

Young Professional Academy

Informed Group is an active member of the AIIM Leadership Council in EMEA. We value the expertise of AIIM when looking at what the future Intelligent Information Management brings.

With every organization we share the demand for talent. Our approach: hire graduates and learn them our trade based upon our values and experience with practical examples. This academy is open to customers as well.

OpenText Documentum Partner

Microsoft Office 365 Partner

Informed Group is one of the largest OpenText partners in Europe and is the to-go to EMEA partner to implement solutions in the SMB Life Science industry. Integrating Documentum and Office 365 is a speciality.

Informed Group uses Office 365 on its own or in combination with Documentum. And always to support user adoption in scenarios that connects people and enterprise needs.

DOLSR: Our Private Cloud

EIM Products

Documentum was created on the demands of regulated industries: Aviation and Life Science.Its Life Science Solution implements the DIA eDM reference model. DOLSR is the only offer of this industry solution, that is tailored to the needs of SMBs.

Other Enterprise Information Management products available from Informed Group are:Collaborative Partner Exchange, SPA4D, SPA4LS, EQMS Express and the Meta Data Publishing Tool.

In 2006, Informed Group was founded and has ever since helped its customers successfully implement information management solutions based on OpenText Documentum and Microsoft Office 365. Today, we help customers solving their business problems with additional means like OpenText InfoArchive, OpenText AppWorks and OutSystems. We are grateful that we had and have the opportunity to work with customers in a broad range of industries. The knowledge we gained is what we share daily in projects we execute.

Informed GroupVijzelmolenlaan 8b3447 GX WoerdenThe Netherlands

www.informedgroup.com+31 (0)348 342115

jeroen.jansen@informedgroup.com

Tom StaesSales Manager BeLux

Jeroen R. JansenCEO, Owner and Founder

+31 (0) 6 11 31 07 48 +1 (337) 4664 622

tom.staes@informedgroup.com+32 (0) 468 544 916