DOLSR QAOpenText Life Science Suite for

Quality and Manufacturing

M Y N A M E I SED STEENHOEKMANAGER BUSINESS SOLUTIONS

CONNECTING PEOPLE

TO THE ENTERPRISE

ENTERPRISE

INFORMATION

MANAGEMENT

With the progression of technology, the world that we know

today will soon be history. Sometimes that makes me sad

as we do not always care enough for what we leave behind.

Fortunately, most times I do see and understand what that

progression brings to the world and to me. That latter addition

is not written from egoism. It is there because change is the

easiest when you can relate it to yourself.

That being said, change forced upon you by new regulations

are not always easy to relate to yourself or the patient down

the line for which a new medicine is being produced. This is

where the above average work ethic in the pharmaceutical

industry comes into play. Change is accepted because that

is what is needed to make high quality and better medicines.

Regulations and work ethic can also become a limiter to

progression. In other industries, new technical solutions are

used sooner. And that is not a problem as long as there is a

driver to also leverage these new technology in your industry.

One of the sources for these drivers can be outsourcing.

The Life Science industry is know for splitting and merging

companies as well as outsourcing work to specialist

companies e.g. CMO’s. But not always. And then you still

not to ensure that quality meets the requirements without

spending too much. So here too, a balancing act is required.

To provide a solid foundation, that allows you as a Quality and

Manufacturing organisation to spend the budget wisely, we

created DOLSR. A modular implementation of the OpenText

Life Science suite with some extra’s and running on a proven

compliant cloud. In this case, it is DOLSR QA. The business

solution for Quality and Manufacturing. On top of the Quality

and Manufacturing module, we provide an embedded Quality

Management solution, a Learn Management solution and an

integration with Microsoft Office 365 / SharePoint On-line.

This business solution ins compliant with the DIA reference

models and thus helps to reduce your compliance efforts.

DOLSR QA is aimed at smaller companies to leave enough

resourcing for your own technology progression in e.g.

analytics or machine learning and still put you in the best

position to compete and comply.

Technology Change Has No Speed Limiter, Only a Speed Pedal

Jeroen Jansen, CEO

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

Quality & Manufacturing Partner Exchange

Quality Management Compliance

The OpenText Documentum Quality and Manufacturing module enables Life Sciences organizations to control quality and manufacturing documents, automate workflows across the extended enterprise, and ensure compliance with GMP (Good Manufacturing Practices) standards.

Collaborative Partner Exchange Only enables full control over external content from clients and partners. Only content that meets your quality standards will be transferred to the Documentum repository. Includes automated meta data enrichment to comply with your dictionaries.

CAPA’s, Deviations, Audits and all other quality events are captured and managed with EQMS Express. Unique is that this is an embedded solution for the Life Science Suite. This enables enhanced integration with controlled documents that are linked to a quality event.

With Documentum for Quality and Manufacturing,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.

LearningThe LMS365 Learn Management product enables the management of all training requirements. Not only To Be Read procedures but also the management of certifications and qualifications as well as control over new hire training or job promotion training, are at your fingertips.

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

What are the characteristics of DOLSR QADOLSR QA is a business solution that leverages the technical capabilities of 4 products. The main part is the Quality and Manufacturing module of OpenText Documentum for Life Sciences,. This is enhanced with Informed Products’ EQMS Express, an embedded quality management product. With the eLearningForce LMS365 add-on a full learn management product is provided to all you to meet training compliancy. The last product is Informed Products’ Collaborative Partner Exchange for controlled exchange of information with partners or clients.

Quality and Manufacturing moduleHow to benefit from the

Available on-premises or in the cloud, the solution is built on OpenText™ Documentum™, the industry’s leading and most scalable content management platform, and complies with the Drug Information Association (DIA) GMP Quality Systems reference model for consistent document modelling. This includes specifications, methods, labelling and master batch records, as well as procedures, governance, corporate policies, validation reports and many other document types. The solution expands upon the DIA reference model by supporting medical device documents, including collated Design History Files and Device Master Records.

Quality and Manufacturing feature chartControlled authoring

Enforce authoring standards with controlled content templates and ability to automatically populate text from document properties, reducing errors and rework

Collaborative authoringCollaborate with internal users and external partners with real-time collaborative authoring and annotation capabilities.

Enforced document change controlRequire document change requests on change controlled document types, configure to make them optional for business process flexibility or disable and integrate if using third-party solutions.

Automated review and approval processesEnsure appropriate steps are taken for each document type with predefined lifecycles and workflows. Multiple users can perform simultaneous review and approval from any device.

Configurable views and watermarksSupports print and export control, as well as pre-configured, dynamic watermarking, with overlays to ensure document security.

Controlled and issued printingUnique print and reprint number and automated recall or reconciliation help to ensure compliance with print control requirements of FDA and EMA data integrity guidance.

Automated periodic reviewTrigger workflows to ensure reviews are started and completed on time.

Streamlined document change managementTrack new versions, edits and deletions automatically in an audit trail to maintain accountability.

Tracked “read and understood”Distribute, track and report all “read and understood” actions to employees.

Automated technical transfer processTransfer documents seamlessly between regulatory and quality domains in a single step to ensure content consistency and traceability.

The Quality and Manufacturing module addresses the challenges of managing documents governing manufacturing, quality, compliance and other standard operating procedures.

It provides prebuilt templates and lifecycles, automated workflows and support for parallel collaborative authoring and review, giving users consistent, accurate, compliant and quality documentation.

This extensive out-of-the-box functionality, built on more than 25 years of experience in the Life Sciences industry, shortens implementation time while providing robust configuration capabilities. And, when a change to documentation is required, such as during a scheduled periodic review, the entire process is automated and tracked.

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

DOLSR QA is 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