Efficient management of documentation is key to the successful development of new molecules. It is also often one of the most challenging aspects of managing a clinical program. There are efficiencies to be had through the use of an electronic system compared to paper, however, these systems can be time consuming and expensive to put in place. This webinar will focus on the challenges and opportunities that small to medium enterprises face when trying to improve their document management processes within the context of clinical trials.
Topics will include:
• Where we have come from and where we are today
• Drivers to adopt electronic document and records management
• Changing regulatory expectations
• 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
• Future Trends in Records Management
SharePoint for Pharma - A Risk-Based Validation Approach for Life SciencesMontrium
SharePoint for Pharma - SharePoint & 21 CFR Part 11
A Risk-Based Validation Approach for Life Sciences.
Presented by Paul Fenton, President & CEO of Montrium Inc.
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
or email info@montrium.com
Executing Validation of GxP Systems Electronically using SharePointMontrium
Executing Validation of GxP
Systems Electronically using
SharePoint
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
or email info@montrium.com
SharePoint for Pharma - Computer System Life Cycle ManagementMontrium
SharePoint for Pharma - Computer System Life Cycle Management
Presented by Michael Zwetkow, VP Operations, Montrium Inc.
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
- gplus.to/Montrium
or email info@montrium.com
Validating SharePoint for Regulated Life Sciences ApplicationsMontrium
Validating SharePoint for Regulated Life Sciences Applications
Presented by Paul Fenton, CEO & President, Montrium
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
or email info@montrium.com
Case Study – Deploying SharePoint Based eTMF in the CloudMontrium
This document will discuss:
- What is an eTMF
- What is Cloud computing
- Montrium Connect
- eTMF structure in SharePoint
- Document and Records Management in SharePoint 101
- Demonstration
Providing SharePoint Solutions in an FDA Regulated EnvironmentDeb Walther
This talk explains to the IT Professional the reasons behind the FDA regulations and what must be considered when implementing SharePoint in a GxP environment.
Over 5 unique webinar sessions, we’ll share everything you need to know about transitioning to Office 365 and SharePoint Online. These webinars will feature actionable strategy, exemplified by real-world case studies, and practical game plans to help you develop a clear strategy for managing GxP content in the cloud.
The Compliance Playbook Webinar Series is geared towards those looking to migrate from file shares and other legacy EDMS systems - to becoming more agile with Office 365.
We'll take you through:
- Why are Life Sciences Organizations moving to Office 365
- Strategies for Conducting Vendor Assessments of Cloud Vendors
Validation in Office 365: Tools for Acceleration
- Validation in Office 365: Continuous Validation
- Maintaining Oversight for Complete Governance in Office 365
SharePoint Configuration Management – Effective Techniques for Regulated Shar...Montrium
This presentation will include:
• Recap of Validating SharePoint for Regulated Environments
• SharePoint within the GxP context
• Regulatory Requirements
• Industry Standards
• Corporate Standards
• What is Configuration Management?
• Implementation of formal system specific configuration control procedures
• Configuration deployment and version control techniques
• Integration with the validation and change control process
• Importance of leveraging a risk based approach to QC
• Using SharePoint to manage configuration control
Enjoy
If you have any questions please email info@montrium.com
SharePoint for Pharma - A Risk-Based Validation Approach for Life SciencesMontrium
SharePoint for Pharma - SharePoint & 21 CFR Part 11
A Risk-Based Validation Approach for Life Sciences.
Presented by Paul Fenton, President & CEO of Montrium Inc.
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
or email info@montrium.com
Executing Validation of GxP Systems Electronically using SharePointMontrium
Executing Validation of GxP
Systems Electronically using
SharePoint
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
or email info@montrium.com
SharePoint for Pharma - Computer System Life Cycle ManagementMontrium
SharePoint for Pharma - Computer System Life Cycle Management
Presented by Michael Zwetkow, VP Operations, Montrium Inc.
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
- gplus.to/Montrium
or email info@montrium.com
Validating SharePoint for Regulated Life Sciences ApplicationsMontrium
Validating SharePoint for Regulated Life Sciences Applications
Presented by Paul Fenton, CEO & President, Montrium
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
or email info@montrium.com
Case Study – Deploying SharePoint Based eTMF in the CloudMontrium
This document will discuss:
- What is an eTMF
- What is Cloud computing
- Montrium Connect
- eTMF structure in SharePoint
- Document and Records Management in SharePoint 101
- Demonstration
Providing SharePoint Solutions in an FDA Regulated EnvironmentDeb Walther
This talk explains to the IT Professional the reasons behind the FDA regulations and what must be considered when implementing SharePoint in a GxP environment.
Over 5 unique webinar sessions, we’ll share everything you need to know about transitioning to Office 365 and SharePoint Online. These webinars will feature actionable strategy, exemplified by real-world case studies, and practical game plans to help you develop a clear strategy for managing GxP content in the cloud.
The Compliance Playbook Webinar Series is geared towards those looking to migrate from file shares and other legacy EDMS systems - to becoming more agile with Office 365.
We'll take you through:
- Why are Life Sciences Organizations moving to Office 365
- Strategies for Conducting Vendor Assessments of Cloud Vendors
Validation in Office 365: Tools for Acceleration
- Validation in Office 365: Continuous Validation
- Maintaining Oversight for Complete Governance in Office 365
SharePoint Configuration Management – Effective Techniques for Regulated Shar...Montrium
This presentation will include:
• Recap of Validating SharePoint for Regulated Environments
• SharePoint within the GxP context
• Regulatory Requirements
• Industry Standards
• Corporate Standards
• What is Configuration Management?
• Implementation of formal system specific configuration control procedures
• Configuration deployment and version control techniques
• Integration with the validation and change control process
• Importance of leveraging a risk based approach to QC
• Using SharePoint to manage configuration control
Enjoy
If you have any questions please email info@montrium.com
SharePoint And 21 CFR Part 11 Share Festpaulkfenton
Presentation given at the ShareFest conference, Philadelphi - April 8th 2010.
This presentation discusses a risk based approach to validation of SharePoint for regulated environments.
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...Montrium
Want to deploy a new technology solution but not sure where to begin? These slides cover key considerations for choosing a vendor with cloud compliance and validation in mind. With the Office 365 subscription-based service gaining considerable momentum in the life sciences, it's important to stay ahead of the technological and regulatory curve and consider how an EDMS system will bring improvements to managing your GxP content.
Here we cover the following topics:
-Vendor assessment of Microsoft
-Subscription basics of Office 365
-Review of ISO/SOC audit reports
-Ensuring that no critical observations are made
-Security and quality controls in place
You can follow along with this presentation via webinar format:
https://info.montrium.com/strategies-for-conducting-gxp-vendor-assessment-of-cloud-service-providers
Why Are Life Science Companies Moving to Office 365?Montrium
The webinar will cover the following topics:
-Moving away from costly and inefficient legacy systems
-Key GxP features and capabilities available in the cloud
-Case studies of Office 365 across the life sciences landscape
-What comes with a continuous Office 365 Validation Subscription?
-Montrium methodology, tools, and documentation available to you
The semantic web an inside look at the creation of control loop foundationEmerson Exchange
The book Control Loop Foundation and its companion website controlloopfoundation.com have been widely used. One of the reasons for this was the team’s decision to allow access to study materials and labs from a wide-variety of PCs and Tablets. Doing this required putting a web interface on top of DeltaV, supporting multiple browsers, and providing access to continuous and historical data from web pages. Details on the web site design and construction are addressed in this workshop.
Why a Document Control System Makes Good Business SenseIBS America
In the newest webinar presented by IBS America, see how you can improve business efficiency by deploying an efficient Document Control System.
In these slides, we covered how to:
-Mitigate risks
-Reduce operational costs
-Improve customer satisfaction
-Improve audits
How To Build A Change Control System with SharePointDux Raymond Sy
Presented by Dux Raymond Sy
meetdux.com
SharePoint Technology Conference
June 24, 2009
Cambridge, MA
Watch Recorded Screencast: http://vimeo.com/5358854
PharmaCODE - Customer Relationship Management (CRM)software solution for pharmaceutical representative companies.
PharmaCODE can help boost your business.
SharePoint And 21 CFR Part 11 Share Festpaulkfenton
Presentation given at the ShareFest conference, Philadelphi - April 8th 2010.
This presentation discusses a risk based approach to validation of SharePoint for regulated environments.
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...Montrium
Want to deploy a new technology solution but not sure where to begin? These slides cover key considerations for choosing a vendor with cloud compliance and validation in mind. With the Office 365 subscription-based service gaining considerable momentum in the life sciences, it's important to stay ahead of the technological and regulatory curve and consider how an EDMS system will bring improvements to managing your GxP content.
Here we cover the following topics:
-Vendor assessment of Microsoft
-Subscription basics of Office 365
-Review of ISO/SOC audit reports
-Ensuring that no critical observations are made
-Security and quality controls in place
You can follow along with this presentation via webinar format:
https://info.montrium.com/strategies-for-conducting-gxp-vendor-assessment-of-cloud-service-providers
Why Are Life Science Companies Moving to Office 365?Montrium
The webinar will cover the following topics:
-Moving away from costly and inefficient legacy systems
-Key GxP features and capabilities available in the cloud
-Case studies of Office 365 across the life sciences landscape
-What comes with a continuous Office 365 Validation Subscription?
-Montrium methodology, tools, and documentation available to you
The semantic web an inside look at the creation of control loop foundationEmerson Exchange
The book Control Loop Foundation and its companion website controlloopfoundation.com have been widely used. One of the reasons for this was the team’s decision to allow access to study materials and labs from a wide-variety of PCs and Tablets. Doing this required putting a web interface on top of DeltaV, supporting multiple browsers, and providing access to continuous and historical data from web pages. Details on the web site design and construction are addressed in this workshop.
Why a Document Control System Makes Good Business SenseIBS America
In the newest webinar presented by IBS America, see how you can improve business efficiency by deploying an efficient Document Control System.
In these slides, we covered how to:
-Mitigate risks
-Reduce operational costs
-Improve customer satisfaction
-Improve audits
How To Build A Change Control System with SharePointDux Raymond Sy
Presented by Dux Raymond Sy
meetdux.com
SharePoint Technology Conference
June 24, 2009
Cambridge, MA
Watch Recorded Screencast: http://vimeo.com/5358854
PharmaCODE - Customer Relationship Management (CRM)software solution for pharmaceutical representative companies.
PharmaCODE can help boost your business.
Life science companies expect electronic trial master file (eTMF) projects to provide greater efficiency, improve quality, increase standardization and enhance collaboration in TMF management. Join Paragon Solutions for the second session of our TMF webinar series to gain insights on the practical factors to consider when planning a new or improved future state eTMF. We'll share industry data on eTMF drivers, and discuss our definition of a robust eTMF. You'll learn why TMF information architecture is so critical to eTMF uptake and usability, and high level considerations for systems integration/migration. Finally, we'll define the maturity framework that allows for assessment of eTMF organizational readiness, a critical baseline to successful future state eTMF planning.
Beyond Automation: Extracting Actionable Intelligence from Clinical TrialsMontrium
To meet the challenge we must break down organizational and procedural silos by:
- Leveraging new technologies and work methods
- Map out, re-engineer, automate and integrate processes
- Leverage and establish procedural and data standards
- Integrate computerized systems and data sources
- Identify clear and measurable metrics and KPIs
- Align and integrate the quality system with automated processes
CDISC & Risk Based Monitoring to Compress Clinical Trial DurationClinical Data Inc .
Technology adoption in the clinical trial space has lagged other industries resulting in high cost / risk of new drug development and ongoing safety concerns of clinical trials.
The focus of this presentation is to educate bio-pharma companies, data managers and CROs on technological advances in the clinical trial space.
This session from the Institute of Validation Technology's 14th Annual CSV Conference looks at B. Braun’s journey in moving from an in-house validated training tracking system to learning management in the cloud.
Provide recommendations and background information concerning computerised systems
Information will be of assistance to inspectors for training purposes and during the inspection
Where automated systems and electronic records are used in warehouses and similar establishments where GDP requirements are applicable, controls and disciplines outlined in this document, or a best practice alternatives are expected to be in place.
Vertically integrated companies (R&D, manufacturing and distribution) will already apply such controls and compliance measures.
International regulatory agencies have collaborated to produce this guidance.
Intended as a reference for regulated users, including their suppliers, in addition to regulatory inspectors and investigators.
Provides a logical explanation of the basic requirements for the implementation, validation and operation of computerised systems.
May be adapted to identify the criteria for a regulated user, or a regulatory agency, in an inspection of GxP computer systems.
National legislation should to be referred to when determining the extent to which the provisions laid down in this document may be applicable.
This presentation gives a summary of this guidance.
CODEX Validation Group is a consulting company with broad experience in the cGMP, compliance, automation, and validation for the Pharmaceutical, Biotechnology and Medical Device industries committed to follow the highest ethical standards as we work with our customers.
This presentation is compiled by “ Drug Regulations” from freely available resources like the FDA on the World wide web. “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
How to Leverage SharePoint 2013 to Organize, Label, Navigate, and Search Your...J. Kevin Parker, CIP
At the end of this presentation, you should be able to articulate why good information architecture (IA) makes SharePoint better; identify the four systems of IA components; leverage SharePoint features for improved information management; and build dynamic information management solutions in SharePoint without code.
This presentation describes a case study of an eTMF structure, setup, and implementation at a biotechnology company currently conducting a pivotal Phase 3 clinical study in 70 centers worldwide.
Gone are the days of using spreadsheets to manage clinical trials. Fortunately, a clinical trial management system (CTMS) such as Oracle Siebel CTMS, offers an effective method for streamlining business processes, reducing cost and saving time.
Whether you are a sponsor running global trials or a research organization conducting hundreds of studies, Perficient’s Param Singh, Director of Clinical Trial Management Solutions, will teach you:
What a CTMS is and who needs one
Key functions of a CTMS
CTMS selection process
System types and implementation options
Best practices
Implementing an Integrated Quality Management System in SharePointMontrium
Implementing an Integrated Quality Management
System in SharePoint
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
or email info@montrium.com
In his Data Management Workshop at the 8th ETOT Summit in London, October 2016 - DataGenic's CTO Colin Hartley looked at trends and best practice when it comes to commodity data management. As well as sharing the dos and don'ts of forward curve creation and management.
10-3 Clinical Informatics System Selection & ImplementationCorinn Pope
Section ten, module three of the clinical informatics course discusses the information system lifecycle. In this slide deck, we'll cover how to pick a clinical information system that works best for you. Also included are three free practice questions. If you would like more information or resources, be sure to check out our site at http://www.informaticspro.com.
A Brief Introduction to Enterprise Architecture Daljit Banger
Presentation to Metropolitan University (London) on the 16th Feb 2017.
The purpose of the session was to introduce core basic concepts around Enterprise Architecture and discuss the role of the Enterprise Architect .
Automation of document management paul fenton webinarMontrium
In the life sciences, most of the documents we create end up as records. Now, as we move towards a paperless era in today’s GxP environment and leverage digital content management technology, we are also starting to change the way that we author, collaborate, manage, exchange, and archive our documents.
The very nature of document management is transforming as more and more data becomes part of the document management landscape. In this webinar, we explore how technology is transforming our GxP records management environments and what the future may hold for automating processes
This presentation was provided by Daniel Calto of Elsevier during the NISO virtual conference, Research Information Systems: The Connections Enabling Collaboration, held on August 16, 2017.
Conference Room Prototype – a low cost, high value approach to selecting the ...Mekon Ltd.
How can you best evaluate a solution before making the big investment? Over several years Mekon has worked with many companies, from medical and semi-conductor manufacturers to software and professional publishers, helping them to select a technology solution fit for purpose. Gathering requirements and choosing the right tools is often more difficult than many companies expect. Use cases and non-functional requirements that accurately reflect what you need are crucial to the success of any IT project, yet evidence suggests typical use cases and requirements are too loose and high level to really do the job.
This presentation will:
* Explain methods that Mekon has developed.
* Evaluate customer experience in conducting the Conference Room Prototype (CRP).
* Outline what metrics can be used to evaluate the tools and what surprises you may encounter.
Identity and Access Management for User login and departmental level and federation level. User can be easily manageable through identity and access Management
Process mapping for Information Management professionalsSimon Rawson
This presentation was delivered at the Records and Information Management Professionals' Association July 2019 Victoria seminar. The aim is to provide an overview of process mapping in an information management context for Information Managers.
Similar to Document Management in the Life Sciences - New Horizons for Small-Medium Enterprises (20)
Monitoring Beyond COVID-19: Setting Yourself Up for the New-NormalMontrium
The Covid-19 pandemic has forced the pharmaceutical and medical device industries to explore methods beyond the traditional on-site monitoring and auditing of clinical trial sites. It has enabled companies to leverage both existing technologies and quickly adopt new methodologies to ensure data integrity and patient safety.
With these changes, companies are able to identify opportunities for both increased quality and efficiencies in their clinical trials.
In this webinar, we will discuss:
Opportunities and the challenges of the “new normal” in the management and oversight of clinical trials
Insights into how we think technology will evolve in the future to better support new risk based approaches to oversight
AI's growing role in clinical trial oversight
Best Practices for Implementing Robust Governance Processes in Office 365Montrium
With Office 365 cloud services, it’s up to customers to manage GxP data governance, authorize access, and configure settings to ensure data integrity. However, given Office 365’s highly customizable nature, many teams face frustrations when establishing governance provisions.
To combat the challenges that come with a continuously evolving system, we will share how you can establish/adapt governance processes to accommodate for smaller, frequent changes. During the webinar, you will learn how Office 365 customers' data benefits from having multiple layers of granular control within a robust governance model to support the management of GxP content.
The webinar covers the following topics:
Overview of IT Governance
Risk-based approach tied to Governance: identifying and mitigating risks in the cloud
Methodology for a good Office 365 Governance strategy
Office 365 Governance with Technical Controls
Compliance Monitoring Overview
Strategies to Facilitate GxP Processes Deployment in Office 365Montrium
Moving your existing environment to manage regulated content in a new Office 365 environment requires a rigorous amount of attention to detail, and any overlook can lead to more significant problems down the road. Whether you’re coming from working within legacy applications or pre-existing infrastructure, you must take the right precautions.
When deploying GxP processes in Office 365, you will need to leverage a deployment approach that can address both technical considerations while accounting for the distinctions in your organizational culture and specific user requirements.
How to Get Started with GxP Processes in Office 365 - The Discovery PhaseMontrium
The webinar covers the following topics:
-How the GxP Design and Delivery Landscape is Changing (digitization of processes, cloud adoption, agile adaptation, better relationships with service providers)
-Business Analysis for Office 365 and the Cloud (methods applied in a Discovery that meet life science trends)
-Discovery Goals (relationships, vision, delivery and enablement of GxP solutions in Office 365)
-Discovery Walkthrough (methodology, sessions, best practices)
How to prepare for an audit and maintain oversight within your e qmsMontrium
In this webinar, not only will we take you through what you’ll need to do to prepare for an audit, but we will also share what you can do to contribute to continuously improve and maintain oversight of your QMS.
Transforming eTMF Management: Moving to a Data-Driven ApproachMontrium
We are moving towards a digital age of automation in clinical trials where electronic management of content and data to document activities and decisions is the industry-wide norm.
This means that the concept of TMF is also evolving and is no longer just a document repository, but rather a collection of systems holding content and data. As a result, there is a strong business case from moving away from just archiving documents to actively managing TMF content and information using techniques and practices borrowed from clinical data management.
In this webinar, we will look at how you can use queries, data review and process-based approaches to ensure that your TMF tells an accurate and complete story of what occurred in your study. We will also discuss the greater scope of TMF relevant information and systems and how you can best integrate these sources into a more holistic environment to greatly facilitate inspections and clinical trial oversight.
Best practices for preparing for and surviving inspectionsMontrium
We will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection.
Best practices for preparing for and surviving inspectionsMontrium
We will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection.
Implementing Metrics & Completeness Reporting in TMF ManagementMontrium
Completeness is a key measurement for TMF to assess inspection readiness, however most organizations and eTMF systems are unable to calculate it accurately. The reason for this is primarily due to a lack of information or knowledge of study design and events that have occurred or that will occur in the study.
In this webinar, we will discuss strategies for calculating accurate completeness as well as review other key metrics that enable you to assess your TMF health and inspection readiness.
Empowering Active TMF Management With an eTMF SystemMontrium
Active TMF Management is critical when conducting a trial. Managing your trial documentation on an on-going basis will allow organizations to have greater oversight on the completeness, empower team members to submit content in timely manner, and ultimately be continuously inspection ready all the while monitoring the quality of your documents.
In our upcoming webinar, we will be exploring how to use an eTMF system to its full capacity by empowering active TMF Management. We'll start by understanding the measurable benefits gained by managing an active TMF and the disadvantages of having a passive TMF repository.
We will also dive deeper into some of the features Montrium has developed as part of our eTMF which empowers clinical teams and gives organization's the tool to have a successful study.
During this webinar, you'll learn:
• What challenges are present when using an eTMF solely as a repository?
• What it means to have active TMF Management with an eTMF System
• How to empower clinical teams to collaborate and treat TMF as a living document
• What tools an eTMF provides to allow for active management
• What benefits active TMF management provides
• Introduction to Montrium's eTMF
• Plus much more...
With Office 365 cloud services, it’s up to customers to manage data governance, authorize access, and configure settings to ensure data integrity. Montrium's Professional Services team has extensive experience working to mitigate the frustrations that teams face when establishing governance provisions for Office 365.
In this webinar, your host Chrysa will discuss how Office 365 customers' data benefits from having multiple layers of granular control within a robust governance model to support the management of GxP content.
-The webinar will cover the following topics:
-Office 365 governance strategy and model overview
-Documents that contribute to SharePoint Online governance
-Governance considerations for GxP and non-GxP use
-Identifying and mitigating risks in the cloud
-And much more...
The Webinar will cover the following topics:
• What challenges are present when using an eTMF solely as a repository?
• What it means to have active TMF Management with an eTMF System
• How to empower clinical teams to collaborate and treat TMF as a living document
• What tools an eTMF provides to allow for active management
• What benefits active TMF management provides
• Introduction to Montrium's eTMF
• Plus much more...
Practical Steps to Selecting and Implementing an eTMFMontrium
There are many benefits to moving to an electronic Trial Master File (eTMF) and many organizations are either thinking of moving, or are already in the process of doing so.
However, there are a great deal of things to consider before being able to successfully move to an electronic platform which are often overlooked, often resulting result in unsuccessful or sub-optimal eTMF implementations.
This webinar takes you through some of the practical steps that you need to go through to successfully implement and benefit from an eTMF.
Tools for Accelerating Validation of Office 365Montrium
It can be overwhelming navigating the evolving requirements pertaining to records management in electronic systems, even for the more experienced validation veteran. In this presentation, discover key insights on Office 365 validation to serve your clinical and regulatory needs.
Ultimately, the responsibility to validate GxP applications is on customers and partners of Microsoft - so we take a look at how to build out a validation plan and control protocols for successful integration with your existing system.
We uncover how Office 365 satisfies specifications of FDA’s 21 CFR Part 11 and EU Annex 11 from both a procedural and technical approach to satisfy regulatory conditions, and how the balance of shared responsibilities between Microsoft and its life sciences customers can satisfy regulatory requirements.
Develop a clearer overview of how to adapt validation techniques to the cloud, as well as key validation expectations and deliverables in Office 365.
The presentation covers the following topics:
-Preparation and adaptation of validation deliverables
-How to build a validation plan: scope and risk rationale
-Risk-based validation planning
-Regulatory compliance impact assessments for Office 365
-Components to be qualified and validated in the cloud
-Developing a validation summary report
Since its release in 2010, The DIA’s TMF Reference Model has proven to be extremely valuable to the life sciences industry. In this content-packed webinar, we will provide a history and overview of the Model, present its structure, and the various sub-groups and resources available. The Model is not intended to be used “off-the-shelf" but can be implemented according to certain expectations and requirements of life science sponsors (pharma, bio, device), investigative sites (academic, for-profit, nonprofit) and CROs / third-party team members alike.
Paul Fenton, CEO of Montrium and CGI Life Science’s Fran Ross, both Members of the TMF Reference Model Steering Committee, will discuss strategies for implementing the Model and how it can be used to ensure tight controls of GxP required content for inspection. Finally, the session will present the TMF Reference Model Exchange Mechanism Standard which extends the Model's capability to facilitate eTMF interoperability and content exchange.
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...Montrium
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Automating the Regulatory Submission Process - Reducing Time and Increasing Q...Montrium
In this presentation, we will be exploring how technology can be leveraged to improve submission readiness and the quality of your electronic submissions. Discover why planning submissions is important, and examine some of the key components of a successful submission readiness plan.
Follow along via webinar format:
https://info.montrium.com/webinar-automating-the-regulatory-submission-process
The way we manage the TMF is constantly evolving. Regulations are often catalysts to change in the eTMF space and staying on top of industry trends is vital in making sure you are working in the best possible way.
In our presentation, we will be exploring 5 of the hottest trends in the future of eTMF which include interoperability, traceability and data integrity, challenges of inspection when data is spread in multiple systems, and how the industry would be affected by the potential ratification of the TMF Reference Model by ICH.
We will also dive deeper into the inner workings of these trends and how we can begin to solve some of these issues which are spreading in the industry.
The presentation covers the following topics:
- Where the industry is today regarding eTMF
- What regulatory bodies are initiating change in the clinical space
- How the ICH is a catalyst to change in the TMF reference model
- Traceability and data integrity in today's model
- Challenges of inspection with disparate systems
- Interoperability and the future of eTMF
- Plus much more...
Follow along via our webinar:
https://info.montrium.com/the-future-of-etmf-actionable-industry-trends-and-insights
In this presentation, we explore the ways you can get internal buy-in and how to build out your business case. We will start by breaking down an eTMF business case and going through the sections you’ll need to include to have a successful meeting internally.
Follow along via our webinar:
https://info.montrium.com/webinar-how-to-build-the-business-case-for-an-etmf-system
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Key Trends Shaping the Future of Infrastructure.pdfCheryl Hung
Keynote at DIGIT West Expo, Glasgow on 29 May 2024.
Cheryl Hung, ochery.com
Sr Director, Infrastructure Ecosystem, Arm.
The key trends across hardware, cloud and open-source; exploring how these areas are likely to mature and develop over the short and long-term, and then considering how organisations can position themselves to adapt and thrive.
Kubernetes & AI - Beauty and the Beast !?! @KCD Istanbul 2024Tobias Schneck
As AI technology is pushing into IT I was wondering myself, as an “infrastructure container kubernetes guy”, how get this fancy AI technology get managed from an infrastructure operational view? Is it possible to apply our lovely cloud native principals as well? What benefit’s both technologies could bring to each other?
Let me take this questions and provide you a short journey through existing deployment models and use cases for AI software. On practical examples, we discuss what cloud/on-premise strategy we may need for applying it to our own infrastructure to get it to work from an enterprise perspective. I want to give an overview about infrastructure requirements and technologies, what could be beneficial or limiting your AI use cases in an enterprise environment. An interactive Demo will give you some insides, what approaches I got already working for real.
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
Accelerate your Kubernetes clusters with Varnish CachingThijs Feryn
A presentation about the usage and availability of Varnish on Kubernetes. This talk explores the capabilities of Varnish caching and shows how to use the Varnish Helm chart to deploy it to Kubernetes.
This presentation was delivered at K8SUG Singapore. See https://feryn.eu/presentations/accelerate-your-kubernetes-clusters-with-varnish-caching-k8sug-singapore-28-2024 for more details.
Slack (or Teams) Automation for Bonterra Impact Management (fka Social Soluti...Jeffrey Haguewood
Sidekick Solutions uses Bonterra Impact Management (fka Social Solutions Apricot) and automation solutions to integrate data for business workflows.
We believe integration and automation are essential to user experience and the promise of efficient work through technology. Automation is the critical ingredient to realizing that full vision. We develop integration products and services for Bonterra Case Management software to support the deployment of automations for a variety of use cases.
This video focuses on the notifications, alerts, and approval requests using Slack for Bonterra Impact Management. The solutions covered in this webinar can also be deployed for Microsoft Teams.
Interested in deploying notification automations for Bonterra Impact Management? Contact us at sales@sidekicksolutionsllc.com to discuss next steps.
Neuro-symbolic is not enough, we need neuro-*semantic*Frank van Harmelen
Neuro-symbolic (NeSy) AI is on the rise. However, simply machine learning on just any symbolic structure is not sufficient to really harvest the gains of NeSy. These will only be gained when the symbolic structures have an actual semantics. I give an operational definition of semantics as “predictable inference”.
All of this illustrated with link prediction over knowledge graphs, but the argument is general.
2. 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
3. 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
4. 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
5. Many, Many different documents
TMF
(~350 Types)
Regulatory
Docs
(~150 Types)
Quality
Docs
(~30 Types)
Other
Docs (~300 Types)
6. 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?
7. Why
• Documents are produced by many different
stakeholders in many different locations
• EDMS type systems have been traditionally
expensive 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
8. 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?
9. 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
–
–
–
–
–
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
• EDMS – Cloud based
10. Drivers to implement an EDMS
eCTD
Information /
Knowledge
Management
Lack of
Security and
Control
Versioning
Issues
Global
Teams
EDMS
Too
Much
Email
Due
Dilligence
Archiving
Cost /
Space
Partnerships
11. 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)
12. 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
13. 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
14. 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
15. 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
16. 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
17. 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
18. 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
19. 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
20. Importance of establishing a
Taxonomy
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
21. 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
22. How to define your taxonomy?
• Establish taxonomy governance rules
• Perform a GAP assessment of your existing
standard and the reference models to define an
initial taxonomy
• Organize the GAP assessment in a document
with current standard and proposed standard
• Leverage the reference models as much as
possible
• Define standard sets of metadata
• Organize work groups with the different
functional areas to review and refine the standard
• Update and deploy
23. 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 readiness
can be challenging without an EDMS
• Difficult to archive documents from vendors
24. 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
25. 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
27. The Regulators are going
Electronic…Case Study
• 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
27
28. 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
29. 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
30. Future trends in EDMS
• Regulators are going electronic
• Cloud will be the new norm
• Documents will drive more and more
processes
• Documents will be data
• Interchange standards will become
mainstream
31. 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
32. 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!
33. Q&A
If you have a question, please raise your hand
Or you can type a question in the Questions Pane
34. Contact Details
Montrium Inc.
507 Place d’Armes, Suite 1050
Montreal (QC) H2Y 2W8
Canada
+1.514-223-9153
Montrium S.A.
9, Avenue des Hauts-Fourneaux,
L-4362 Esch sur Alzette
Luxembourg
+352.20.88.01.30
pfenton@montrium.com
www.montrium.com