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05.08.24 22 min read

#010: Can your DM do this?

We are on a mission to launch a series of Continuous Managed Services to help our customers with all their major areas of operations (from IT to Manufacturing). We released ContinuousALM last week. This week we are proud to announce the release of ContinuousDM which is the focal point for this newsletter.

ContinuousDM is a state of the art Document Management (DM) App which is powered by Atlassian platform. Document Management is the keystone for any life science company. But only a few of the life science companies implement a solution that is scalable, user friendly and increases the ability to collaborate in real-time while ensuring 21 CFR Part 11 compliance.

I can’t think of a single instance in my 30+ year journey working with 100+ customers worldwide where a life science company rolled out a DM app in a few days with all the best practices built-in including Continuous Validation. In most cases, the end users β€œhated” (I know hate is a strong word) their DM app with a passion.

Why? The answer is simple. Most DM apps used in the GxP world are built on outdated technology stack with Unfriendly UI and very little utility. Their fame to claim is that their app is GxP complaint. In other words, the incumbents use GxP compliance to roll out mediocre products. Compliance is expected in this domain. Compliant app should not be interchangeable with being a β€œlousy” app.

xLM’s goal is break the status quo with an app that can be implemented in a day (I mean it). An app that is continuously validated with a chock full of cutting edge features that are intuitive with AI helping you along the way.

 

Improving Efficiency and Productivity

By organizing documents, ensuring easy access, and streamlining revision control processes, ContinuousDM enhance operational efficiency, reduce errors, and boost productivity within GxP-regulated industries.

ContinuousDM: Efficient Out of the Box

Advantage over Word Documents

Collaborative Authoring

ContinuousDM provides a synchronous online environment that allows for real-time collaboration, enabling users to work on the same document simultaneously, see changes instantly, and engage in discussions efficiently.

Centralized Information

ContinuousDM offers a single source of truth, ensuring that all collaborators access and work on the latest version of the document, reducing confusion and the risk of working on outdated versions. The problem with Word is that a file can be downloaded and worked on offline. This is unacceptable since it causes multiple versions to float around and introduces inefficiencies at every step.

Ease of Access and Updates

With ContinuousDM, it is easier to find and work on the master copy of the document, facilitating seamless updates, discussions, and feedback within the platform, promoting a more streamlined and organized workflow.

Unlimited Extensibility

Our DM app’s functionality can be extended with over 1000+ apps from the marketplace. For example: You can draw diagrams within ContinuousDM, have real-time white-boarding sessions, bring in real-time data from other sources, electronically sign….just to name a few. The concept of using mutliple apps is really outdated to make your document a β€œwhole”! For example: You have to use Visio to draw and then import it into word. What has really changed in the last 30 years or more. Nothing!

Key Features

Audit Trail and Version Control

The audit trail provides a detailed record of all actions and changes made within the documents. This includes information on who accessed, modified, deleted, or shared documents, as well as any changes to permissions or settings. The audit trail helps to track document activity, ensures compliance, and provides alerts of any unauthorized or suspicious actions. The centralized audit logs allow administrators to track who has accessed, created, modified, attempted, and deleted content within the system.

Version control ensures that multiple versions of a document are tracked and managed effectively. It allows users to access previous versions, track changes, and collaborate seamlessly. This feature helps maintain data integrity, enables easy rollback to previous versions if needed, and enhances collaboration by providing a clear history of document edits and revisions.

Audit Trail and Version Control

Search Capabilities

Search capabilities enable users to quickly and efficiently locate documents based on various criteria such as file name, content, metadata, or tags. This functionality streamlines information retrieval, reduces time spent on searching for documents, and enhances productivity. Advanced search features include keyword search, filters, Boolean operators, and wildcard searches, allowing users to find relevant documents with precision.

Search

Inbuild AI Feature

Inbuild Intelligence enhances by providing advanced analytics and insights into user behavior, content usage, and system performance. It offers valuable data-driven recommendations, identifies trends, and helps optimize workflows. By leveraging AI, organizations can make informed decisions, improve efficiency, and enhance the overall user experience.

AI-powered summaries can be accessed directly from a Smart Link without leaving the page, providing users with a quick overview of the content before deciding whether to open the link. It also quickly summarizes long pages into shorter summaries, saving time and improving comprehension.

Built-in AI Summarizing Feature

Use of Macros

The macros are powerful tools that automate tasks, enhance content, and improve collaboration. They allow users to embed dynamic elements, such as tables, charts, and multimedia, into their pages. Macros streamline workflows, provide advanced formatting options, and enable integration with other tools and systems. Overall, macros enhance the functionality and usability of DM, making it easier for teams to create, share, and manage content effectively.

A Sample Macro

These Macros can also extract information from other sources. This keeps the document current as it updates whenever the original data changes.

Macros to import Live Data

Live Data in ContinuousDM

Whiteboards: Where Ideation meets Action

Whiteboards in ContinuousDM act as a digital canvas where teams can freely brainstorm, translate ideas into actionable plans, and visualize work collaboratively.

  • Efficiency: Whiteboards streamline the process of translating ideas into actionable projects and tasks, reducing the need for switching between different tools.

  • Collaboration: Teams can engage in real-time editing, collaborate using stamps, timers, and other tools, facilitating smooth transitions from brainstorming to action.

  • Creativity: Whiteboards foster creativity, enabling teams to generate new ideas, prioritize tasks, and seamlessly convert ideas into actionable items.

  • Visual Elements: Users have access to various visual elements such as sticky notes, stamps, stickers, images, timers, lines, and shapes for creative brainstorming and visualization.

  • Integration: Whiteboards seamlessly connect unstructured ideation to workflows within ContinuousDM, enabling teams to navigate between whiteboards, pages, and issues in a cohesive manner.

  • Actionable Tasks: Whiteboards simplify the process of turning ideas into actionable tasks for team collaboration. Users can easily convert sticky notes into issues, edit issues within the whiteboard, transform whiteboard content into structured pages, connect issues, and bulk-update issues using Smart Sections.

Whiteboarding

E-Signatures

The E-Signature feature offers a comprehensive, secure, and compliant electronic signature solution that is tightly integrated within the platform.

Part 11 Compliant Electronic Signatures

The solution provides Part 11 compliant electronic signatures for documents, including secondary user authentication, content change detection, and signature verification.

Signature Details Capture

It captures the name, title, meaning, date/time, and time zone of each electronic signature.

Streamlined Content Management

It provides a streamlined content management workflow to automatically restrict editing after signatures have been applied.

Status Search and Visibility

Content with open or finalized signatures is automatically labeled for easy search, and an optional macro can display the signature status directly on the page.

E-Signature

Document Review and Comments

Comments allow for collaboration, knowledge sharing, and feedback collection within documents. Users can mention others, attach files, like, reply, edit, and delete comments, making it a versatile tool for communication and collaboration.

Commenting

Document Export

Export functionality enables users to extract documents or data from the system in various formats such as PDF, Word, Excel, or CSV. This feature enhances flexibility and accessibility, allowing users to share or archive documents in preferred formats for offline use or external distribution.

Exporting

Customized Workflows

ContinuousDM allows users to customize workflows to suit their specific Document Management needs. With this, the user can design workflows tailored to your organization's processes, including defining stages, assigning roles and permissions, setting up automated actions, adding conditional logic, and integrating with other tools and systems.

This customization capability enables users to optimize document workflows, streamline processes, ensure compliance, and enhance collaboration within their organization.

Custom Workflows

Classification of Documents and Page/Space level Permissions

The document classification and space-level permissions are key features for organizing and securing content.

Document classification categorizes documents based on sensitivity levels, ensuring proper handling and access control. Space-level permissions enable administrators to define who can view, edit, or manage content within specific areas of ContinuousDM. These features help maintain data integrity, confidentiality, and compliance with regulatory requirements.

Align page access with your data governance policies and centrally manage which users or groups have view or edit permissions. Restriction Schemes enable to restricted page access to specific users or groups based on the classification level of the page. With this you can:

Document Classification

Encryption and Decryption

You can share and restrict access to sensitive information by leveraging user permissions and groups. This ensures that confidential data is accessed only by authorized individuals. We securely store and share various types of sensitive information, including passwords, credit card details, software license keys, and corporate account information.

Secrets Management

Integration with Apps

ContinuousDM integrates with communications apps such as Microsoft Teams and Slack so your team can work better togetherβ€”without all the unnecessary toggling.

Microsoft Teams: Skip the tab surfing by searching, creating, and sharing documents without ever leaving Teams.

Slack: This integration lets you respond to document comments without ever leaving Slack. 

ContinuousDM helps you keep all your documents for easy collaboration

Google Drive: Drop a Google Drive link onto your page and use smart links embed view to edit the page directly within the document.

Microsoft365: Create a single source of truth by uploading and syncing Excel, PowerPoint, and Word files to pages from SharePoint and OneDrive.

Microsoft Teams Integration

Slack Integration

Turn your Data into Insights

Making all your data accessible, modifiable, and presentable will give you a competitive advantage. Put it all into ContinuousDM with add-ons that help organize, manipulate, and visualize data. With better insights, you can sharpen performance and boost innovation.

Building Smarter Spreadsheets

Enhance the functionality of your spreadsheets directly within your documents.

  • Microsoft Excel - Easily incorporate an Excel spreadsheet onto your page using the /excel command to activate the macro.

  • Google Sheets - Simply paste your Google Sheet link onto the page and instantly access a variety of smart link options.

  • Advanced Tables - Utilize features such as column totaling and averaging, numbering, sorting, filtering, CSS styling, and more.

  • Table Filter and Charts - Integrate filters and Gantt charts, execute advanced SQL queries, and include pivot tables.

Make it a dynamic database

A database provides functionalities that go beyond what a spreadsheet can offer.

  • Organized - Incorporate a database with a selection of different field types to organize your data effectively. Afterwards, you can arrange, filter, and present it on your page using linked tables that update automatically.

  • Attributes - Custom forms can be added to your pages, automatically organizing those with the same form into a list. Utilize powerful reports and other tools to filter, sort, and structure data as needed.

ContinuousALM - Delivered as a Managed Service

In every service we offer, the software app is continuously qualified. Also the customer's instance is continuously validated. In each run, 100% regression is performed.  

Continuous Validation Features

Conclusion

If you are looking at managing your documents efficiently while complying with GxP, then ContinuousDM delivers a rich feature set that can get you going out of the box. Since it is delivered as a Managed Service, you can be up and running the same day. You don't have to worry about any validation document or executing any test protocol. It is delivered as an app that is continously validated.

When you take into consideration the rich feature set that can operate within a browser, there is only one option for a robust DM: ContinuousDM.



 

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ContinuousDM is built-on Atlassian products and marketplace apps. xLM, LLC incorportes best practices, automation and configuration settings to make it GxP / 21 Part 11 compliant. xLM LLC delivers ContinuousDM as a continuously validated app to its customers.


 

ContinuousDM FAQs

 

Question

Answer

1. What is ContinuousDM and what problems does it solve?

ContinuousDM is a state-of-the-art Document Management (DM) application specifically designed for life science companies working in GxP-regulated environments. It addresses the common challenges associated with traditional DM systems, such as:

  • Scalability Issues: Traditional DM systems often struggle to scale with growing data volumes and user demands.

  • Poor User Experience: Outdated technology and unfriendly user interfaces lead to frustration and low adoption rates.

  • Limited Collaboration: Lack of real-time collaboration features hinders teamwork and slows down document review processes.

  • Compliance Concerns: Ensuring 21 CFR Part 11 compliance can be complex and time-consuming with traditional systems.

ContinuousDM overcomes these challenges by offering a scalable, user-friendly platform with robust collaboration tools and built-in compliance features.

2. What are the key benefits of ContinuousDM compared to using traditional Word documents?

ContinuousDM offers significant advantages over managing documents in Word, including:

  • Real-Time Collaboration: Multiple users can simultaneously edit the same document, eliminating version control issues and fostering efficient teamwork.

  • Centralized Information: All documents are stored in a single repository, ensuring everyone accesses the latest version and reducing confusion.

  • Enhanced Version Control and Audit Trails: Every change is tracked and logged, ensuring accountability, transparency, and compliance with regulatory requirements.

  • Powerful Search Capabilities: Finding specific documents is quick and easy, thanks to advanced search filters and indexing.

  • Unlimited Extensibility: Integration with numerous apps and extensions provides a comprehensive document management solution.

3. How does ContinuousDM leverage AI to enhance document management?

ContinuousDM integrates AI in several ways to improve efficiency and user experience:

  • AI-Powered Summaries: Quickly grasp the key points of lengthy documents with automated summaries.

  • Smart Links: Gain insights and context without leaving the current document by previewing linked content.

  • Intelligent Search: AI algorithms refine search results, ensuring users find the most relevant information quickly.

4. Can ContinuousDM be customized to fit specific document management workflows?

Yes, ContinuousDM offers extensive customization options to adapt to various workflows:

  • Custom Workflows: Design workflows tailored to your organization's processes, including defining stages, roles, permissions, and automated actions.

  • Document Classification: Categorize documents based on sensitivity levels to ensure proper handling and access control.

  • Space-Level Permissions: Control access to specific areas within ContinuousDM, granting different permissions to users and groups.

5. What security measures are in place to protect sensitive documents in ContinuousDM?

ContinuousDM prioritizes data security with features like:

  • Encryption and Decryption: Data is encrypted both in transit and at rest, protecting it from unauthorized access.

  • User Permissions and Groups: Access to sensitive information is restricted to authorized personnel based on their roles and clearance levels.

  • Secrets Management: Securely store and manage sensitive information, including passwords, credentials, and license keys.

  • Compliance with Industry Standards: ContinuousDM is designed to meet the stringent requirements of 21 CFR Part 11 for electronic records and signatures.

6. How does ContinuousDM support collaboration and document review processes?

ContinuousDM facilitates seamless collaboration through features like:

  • Real-Time Co-Authoring: Multiple users can edit documents concurrently, streamlining teamwork and reducing bottlenecks.

  • Comments and Discussions: Users can add comments, tag colleagues, and engage in discussions directly within documents, fostering efficient feedback loops.

  • Whiteboards: Digital whiteboards provide a shared space for brainstorming, idea visualization, and collaborative planning.

7. Does ContinuousDM integrate with other tools and applications?

ContinuousDM offers seamless integration with popular productivity and communication tools, including:

  • Microsoft Teams and Slack: Streamline communication and document sharing within these platforms.

  • Google Drive and Microsoft 365: Access and edit files stored in these cloud services directly from ContinuousDM.

  • Various Marketplace Apps: Extend functionality further with numerous apps available in the Atlassian Marketplace.

8. How is ContinuousDM delivered and validated?

 

ContinuousDM is delivered as a managed service, meaning:

  • Rapid Deployment: You can be up and running on the same day with minimal setup effort.

  • Continuous Validation: The system undergoes continuous validation, ensuring ongoing compliance with GxP regulations.

  • No Validation Burden: You don't need to worry about managing validation documents or executing test protocols.

  • Expert Support: The service includes ongoing support from xLM experts to assist with any questions or issues.

9. How can I get started with ContinuousDM?

 

If you're ready to experience a streamlined, efficient, and compliant document management solution, contact xLM to learn more about ContinuousDM and how it can benefit your organization.

 


 

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