Document Management in the Life Sciences – New Horizons for

SMEs

Agenda

Where we have come from and where we are today

Drivers to adopt electronic document and records

management

What are my options – Paper, On-Premise, Cloud

Benefits of a structured approach to EDM

Document Management Challenges faced by SMEs

Montrium’s approach to delivering Document

Management for the Life Sciences in the cloud

Changing regulatory expectations

Future Trends in Records Management

Q&A

If you have a question

Raise your hand and I will answer at the end of the webinar

Or you can type a question in the Questions Pane

Where have we come from?

• EDMS has been around for over 20 years

• Life sciences are large producers of documents

• We have focused a lot on data and still have many paper records

• Document Management systems were traditionally thought of as enterprise systems and not readily available to smaller organizations

• New systems are emerging on the cloud

Many, Many different documents

TMF(~350 Types)

RegulatoryDocs

(~150 Types)

QualityDocs

(~30 Types)

OtherDocs (~300 Types)

We still have a Paper Mindset!

• We still organize electronic documents in folders

• We still produce paper or electronic outputs which we systematically sign

• We produce paper-like outputs from electronic systems and file them in our TMF or central files

• We tend to print out content for inspections

WHY?

Why

• Documents are produced by many differentstakeholders in many different locations

• EDMS type systems have been traditionallyexpensive and time consuming to implement

• File shares are relatively inexpensive but require the use of folders to manage content

• File shares are easy to understand

• Without a validated EDMS, it is difficult to meet the requirements of 21 CFR Part 11

What are my options?

• Paper – Still acceptable from a regulatory standpoint

– Easy to understand and implement

– Not very efficient and difficult to find information

– Can be costly to maintain archives during retention period

• Electronic File Share– Mimics paper based system

– Limited search capabilities

– Security can be challenging

– No audit trail

– 21 CFR Part 11 compliant?

What are my options?

• EDMS – On Premise– Typically an enterprise type solution– Can be costly to implement and maintain– Easier to integrate with other applications– Requires in-house expertise to manage system– Not really warranted for smaller organizations

• EDMS – Cloud based– Minimal upfront investment– Pay per use model– Multi-Tennant– Minimal in-house expertise to manage system– WYSIWYG – Minimal customization allowed

unless in a dedicated environment

Drivers to implement an EDMS

EDMS

eCTD VersioningIssues

Global Teams

TooMuch Email

PartnershipsArchiving

Cost / Space

Due Dilligence

Lack of Security and

Control

Information / Knowledge

Management

High Level Requirements of an EDMS

• To be able to:

– Organize and classify all documents and records (content)

– Assign metadata values to content

– Manage collaboration on documents in one central location

– Distribute document templates

– Version documents and maintain document history

– Manage document revisions and source documents

– Manage records centrally and provide access to inspectors / auditors (eTMF)

– Apply retention policies to records

– Apply security and audit trails

– Allow electronic signatures of records

– Provide records for submissions (eCTD)

Benefits of EDMS

• Better version control of documents

• Improved collaboration between study stakeholders

• Improved timeliness of document authoring and collection

• Reduction of document collaboration via email

• Improved security, control and traceability

• More reliable backups of documents and records

Benefits of EDMS

• Reduced document management and archiving costs

• Improved ability to search for content

• Improved knowledge management

• Better regulatory compliance

• More consistent content through the use of templates

How to select and implement a solution…

• Step 1 – Requirements– Establish a clear set of concise and measurable

requirements

– Define your current and future document management processes in a process diagram – Try and standardize if possible

– Decide if you want a cloud based or on-premise solution

• Step 2 – Vendor Identification– Identify potential vendors who could be a good fit for

your organization’s size, needs and processes

– Ask vendors to review your future document management processes and provide a gap assessment between their standard processes and yours

How to select and implement a solution…

• Step 3 – RFI/RFP

– Evaluate whether an RFI/RFP is necessary

– Define how you will evaluate the vendor responses

– Build RFI document based on your requirements

– Evaluate responses and shortlist

• Step 4 – Vendor Selection

– Select vendor based on RFI/RFP response and their ability to meet your requirements

– Perform due diligence – on site or postal audit

– Verify references

– Contract with vendor. If cloud based, make sure that an adequate Service Level Agreement (SLA) is in place

How to select and implement a solution…

• Step 5 – Establish a standard taxonomy– Define a standard set of document names and

metadata

– Leverage the EDM and TMF reference model as much as possible

– Standardize across functional areas

• Step 6 – Establish configuration– Aim to leverage existing configurations from the

vendor as much as possible to save time and cost

– If deploying in-house, the configuration should be governed by the configuration control SOP

– If deploying on the cloud, the vendor should define the configuration with you

How to select and implement a solution…

• Step 7 – Deploy and Validate– If deploying in-house, you should have the

necessary SOPs to validate and manage the system

– You only need to validate customizations and the implementation of your processes (UAT)

– Try and leverage vendor documentation as much as possible

– Cloud based solutions should be pre-validated and only minimal UAT is required

– Roll out in a staged manner

How to select and implement a solution…

• Step 8 – Train, train, train– User adoption of an EDMS can be challenging

– Often users do not understand the concepts such as metadata and document collaboration

– Ensure you have a comprehensive training program in place to facilitate adoption

– Develop cheat sheets and leverage vendor user guides and other documentation

• Step 9 – Expand and maintain– Ensure proper system management procedures are

in place

– Expand the use of the system to other departments or externally to partners and vendors

Leveraging Models and Standards

• Leverage document models. Examples of these could be:

– DIA EDM Reference Model

– DIA TMF Reference Model

– eCTD

• The use of industry models and standards facilitates collaboration, inspection and interchange

• Many vendors have already implemented these models in their solutions

Definition:

•tax·on·o·my (tk-sn-m)n. pl. tax·on·o·mies 1. The classification of organisms in an ordered system that indicates natural relationships.

•2. The science, laws, or principles of classification; systematics.

•3. Division into ordered groups or categories

Importance of establishing a Taxonomy

What can we do with a taxonomy?

• Implement document and information management systems

• Centralize terms and classification across systems to facilitate integration and improve standardization

• Automate processes through use of metadata and classification

• Identify documents/records

• Manage records lifecycle and retention

• Search for information based on predefined classification

• Generate Metrics and KPIs

How to define your taxonomy?

• Establish taxonomy governance rules

• Perform a GAP assessment of your existingstandard and the reference models to define an initial taxonomy

• Organize the GAP assessment in a documentwith current standard and proposed standard

• Leverage the reference models as much as possible

• Define standard sets of metadata

• Organize work groups with the differentfunctional areas to review and refine the standard

• Update and deploy

Document Management Challenges for SMEs

• Cost of Acquisition of on premise EDMS solution is prohibitive

• Lack of in-house staff to manage an EDMS solution

• Lack of time or knowledge to define the configuration for an EDMS

• Inspection / audit / due diligence readinesscan be challenging without an EDMS

• Difficult to archive documents from vendors

Cloud based EDMS Model

• SharePoint 2013 based multi-tenant environment

• Full enterprise EDMS features

• Fully mapped to the EDM and TMF Reference Models

• Pay per user / per month

• Minimal setup cost

• Can be up and running within 2-4 weeks

• Targeted towards SMEs

• Includes full configurations for eTMF and Regulatory documents

How does it work

• Montrium is responsible for the setup and day to day management of your environment

• We follow our own SOPs for things like security, disaster recovery, validation etc.

• We provide you with training and support

• We make all changes to your configuration on your behalf

• You manage all of your documents and metadata

EDMS Components of Montrium Connect

• The EMA published a position paper in February which gave us more clarity on what they are looking for

• It also laid down the conditions by which they wish to inspect eTMFs

• They share the same or similar requirements to the sponsors themselves

The Regulators are going Electronic…Case Study

27

High level eTMF requirements of the regulators

Based on the position paper entitled ‘Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials’, the regulators needs can be summarized as follows:

• To be able to see all study information in one place

• To be able to review this information without intervention from sponsors or clinical site staff

• That information be collated in a timely manner (i.e. be up to date)

• That inspectors are able to reconstruct the events of the study and evaluate compliance with GCP

• That inspectors require a minimal amount of training to be able to use the system

• That potentially inspections could be done at a distance

High level eTMF requirements of a sponsor

• To be able to understand the status of the clinical trial and eTMF in real-time

• To be able to present all eTMF records (documents and data) from different systems in one federated eTMF

• To be able to leverage the eTMF content to facilitate a risk based approach to clinical trials

• To be able to apply a risk based approach to TMF QC

• To be able to view eTMF record structures in different views based on metadata

• To be able to answer key questions through structured and unstructured queries and natural language

• To ensure that the authoritative source is clearly identified and that there is only ‘one version of the truth’

• To reduce the overhead of maintaining an eTMF and transform it into a source of valuable knowledge

• Regulators are going electronic

• Cloud will be the new norm

• Documents will drive more and more processes

• Documents will be data

• Interchange standards will becomemainstream

Future trends in EDMS

Final Recommendations

• Clearly define your EDMS needs and process up front before choosing a solution

• Properly vet cloud based providers to ensure your documents are properly protected

• Try and adopt industry models and best practices which are already built in to the solutions

• Stage your EDMS rollout so as to gradually bring on different functional groups

• Encourage your partners and vendors to collaborate within your environment

Conclusion

• As our world becomes more and more electronic, the need for a fully functional EDMS becomes more important

• There are real cloud based options which now allow SMEs to access enterprise EDMS quickly and cost effectively

• Its time to go paperless!

Q&A

If you have a question, please raise your hand

Or you can type a question in the Questions Pane

Contact Details

pfenton@montrium.com

www.montrium.com

Montrium Inc.507 Place d’Armes, Suite 1050

Montreal (QC) H2Y 2W8Canada

+1.514-223-9153

Montrium S.A.9, Avenue des Hauts-Fourneaux,

L-4362 Esch sur AlzetteLuxembourg

+352.20.88.01.30