The best document management software for life sciences [reviews]


    What are the best document management systems for life science companies? That depends.

    Document management for life sciences can be a time-intensive and difficult process - particularly for growing start-ups and scale-ups. The best document management software can help your organization streamline your entire document process, bringing much-needed efficiency to your information streams.

    But finding the right document management solutions for you is easier said than done. There are dozens of document management companies to turn to. How do you know which one is right for your organizational needs, and what should you focus on in a document management system review?

    In this article we’ll run through how modern document management systems work, unpick the key functionality you need to consider for life sciences content management, then trace a documentation management software comparison to help you decide.


    Understanding how document management systems work


    Document management systems are, in short, the bundle of processes, procedures and storage areas that govern how your company's documented information is controlled.

    Although document management systems can technically be analog and paper-based, the name is typically applied to the electronic document management solutions and software systems that have emerged in the past twenty years or so to modernize how businesses manage their documents.

    Document management system solutions are, then, the dedicated software platforms designed to store, manage, track and organize digital documents and files within an organization. 


    Benefits of document management system solutions


    Document management systems give your company stronger control of your documentation, making day-to-day access easier and connecting your entire company to a single source of truth.

    They typically work by facilitating document capture and upload: users add various file types such as Word documents, spreadsheets, images and PDFs into their document management systems.

    Once documents are uploaded, document management systems store them in a central repository. Documents are typically organized using a hierarchical, configurable folder structure or metadata tagging system. Metadata includes information like document type, author, creation date, and keywords for rapid searchability.

    Document management solutions often include version control capabilities, allowing users to track changes made to documents over time. This ensures that users always have access to the most up-to-date version of a document and can revert to previous versions if necessary.

    The best document management software also enforces access controls to ensure that only authorized users can view, edit or delete documents. Security features such as user authentication, encryption, FDA 21 CFR Part 11-compliant e-signatures and audit trails help protect sensitive information and maintain compliance with regulatory requirements (we'll touch on that more below!)

    Overall? Document management systems streamline your document-centric processes, improving collaboration, boosting data integrity and security, and slicing the time and effort of finding and acting on information.


    Cloud-based document management solutions


    Early document management systems were typically on-premise. That is, they lived on servers physically stored within your organization's four walls.

    But over the past decade or so, cloud-based document management solutions have come to the fore.

    Rather than being hosted on servers you're responsible for, with all the upkeep, maintenance and infrastructure costs and time demands that come with them, cloud-based document management system solutions live on servers run by the document management companies providing the software.

    That frees you from any of the tasks and considerations that come with an on-premise system. Patches, upgrades and hardware purchases are no longer your responsibility.

    And best of all, putting your documents in the cloud gives you access to them from anywhere in the world with an Internet connection. For remotely distributed teams and on-the-go professionals, this can be an invaluable thread of centralized information binding your company together.


    Document management for life sciences companies 


    Why is effective document management so important for regulated companies like medical device and pharmaceutical manufacturers? 

    In simple terms, a robust document management and control system provides the guardrails that a life science organization needs to follow to unlock consistent product quality and compliance with industry standards - which are among the toughest on the planet.

    A document management system is among the most critical tools for achieving compliance in any highly regulated industry, and life science is no different.

    There are six primary benefits of working with document management system providers:

    1. Access control and audit trailing
    2. Stronger compliance
    3. Improved transparency
    4. Increased collaboration
    5. Improved quality management
    6. Improved disaster recovery


    These benefits are of critical importance for life science operations.


    Read our 5 medical device document management tips



    Importance of life sciences document management


    Document and data integrity is at the forefront of life science regulatory compliance.

    Standards like FDA 21 CFR Part 11, ALCOA+ and ISO 27001 all require your business to build robust, repeatable and well-documented processes for how documents are controlled and safeguarded.

    And auditors will expect to see clearly visible, traceable and gap-free audit trails for key actions in your business, like document updates, training of employees, and completion of corrective and preventive actions (CAPAs).

    You could attempt to hit these requirements with a paper-based system. But the manual demands of this approach will bring unnecessary time and money expense.

    AIIM estimates workers with legacy document management systems spend half an hour each day - about 16% of their time - just searching in filing cabinets and drawers for the day-to-day information they need to do their jobs. Cloud-based, digital life sciences content management platforms, on the other hand, cut info-searching down to a matter of seconds.

    And when you factor in the costs of paper and of paper management (about $25,000 a year at a minimum for small companies), turning to paper-free document management systems becomes even more of a no-brainer.


    Get the guide: Why your life science business needs electronic document management



    Best document management software


    Now we've covered what document management systems are and why they're a critical business tool for regulated operations, let's kick off our document management systems comparison by exploring the key features and functionality you should look for in your document management systems list.


    Essential features of document management


    Let's be truthful. Document management systems are all, in general, fairly similar. The basic premise of uploading documents into a digital repository, then managing them with built-in guardrails and controls, is broadly universal among document management system providers.

    We've touched on these general document management solutions features above, and we also built a detailed list of what you need to know about document control software in a separate article

    There's lots of crossover there, since document control and management systems are broadly similar - so we encourage you to check out that article, too.

    At the same time, there are a handful of key, essential differentiators you should focus on to help you pinpoint the best document management software for you. Let's take a look at those now.


    Read the 4 things every pharmaceutical start-up needs for document management







    Who's actually reading and signing off on documents?

    How many are still in draft - and who's responsible for getting them approved?

    And are there key gaps in your life sciences content management system and documents that you're missing?

    To answer these questions quickly and easily with nothing more than a glance at a screen, your document management solutions shortlist should contain those that offer detailed analytics.

    Document management system providers that offer built-in analytics functionality empower you to continuously check and optimize your document activities - shoring up compliance and making your information streams as strong and supported as they can be.



    In-app editing and collaboration


    Editor document collaboration


    Some of the best document management system solutions, like Qualio with its unique fully native in-app eQMS document editor, support collaboration features like commenting and suggestions that enable multiple users to work on a document from beginning to end without ever leaving the software.

    Configurable workflows let you route document tasks like review and approval to designated personnel, allowing your company to digitally execute the entire lifecycle of your documents from creation and editing to archiving and disposal. 

    This is a particularly potent feature you should explore: document management systems without this functionality ultimately force you to rely on separate tools like Word for document writing and editing, where checking documents in and out of your document management system for updates becomes an unavoidable chore.

    Moving everything to a 'one-stop shop' with editing and collaboration removes this headache - and makes your compliance airtight by keeping documents constantly inside a controlled environment.


    Document management systems integrations


    The best document management software systems typically offer some form of integration with other document tools, too. Qualio, for example, integrates with OneDrive to allow our customers to pull documents and their live edits from embedded and well-used legacy tools into their eQMS at the touch of a button.


    Document management software integration OneDrive


    Document management companies


    Our final tip before we move onto our documentation management software comparison and look at some document management software reviews?

    Take a good look at the document management companies themselves. Picking a reputable vendor who commits to long-term customer care and rapid, compliant implementation is just as important as the functionality of the software itself.

    Use third-party review sites like G2 for a reliable, unbiased insight into which document management companies are doing what they say they'll do.


    Best document management software reviews



    Documentation management software comparison


    Without further ado, let's move into our document management software reviews head-to-head!


    1. MasterControl


    First on our document management systems list is MasterControl.

    MasterControl’s document management systems help life sciences organizations - particularly large enterprises - achieve increased compliance and audit readiness. Enterprise businesses with large document management systems budgets leverage MasterControl to automate core their document processes, improve collaboration among stakeholders, and more.


    MasterControl document management software review


    MasterControl is a large, complex system for large businesses to match.

    It's therefore good for building a post-market enterprise quality management system that includes life sciences content management functionality among other modules and features.

    But it lacks any native editing and scores poorly for its ease of use with customers, who report long load times and unintuitive searching.

    And because it's such a heavy platform with layers of functionality, your time to value is expected to be much longer than other document management systems.


    2. QT9


    Next on our document management systems comparison is QT9, a module-based QMS with document control and management capabilities.

    QT9’s document control software allows you to manage your documentation, and its modular format gives life sciences organizations the ability to control and customize the solution to fit their unique needs.


    QT9 review


    QT9 customers report solid document management functionality, with standard tools like custom document numbering, electronic signatures and auto-archiving. Cloud-based access lets you view documents from any device or browser through cross-platform support, while basic dashboards offer personalized views of your document management system.

    But users also report an unintuitive, cluttered UI with lots of menus. There's no native document editing, forcing you to check documents out for edits and updates. 


    3. Arena


    Arena’s eQMS is a common feature in document management reviews. It features a cloud-based document management system designed particularly for large medical device companies. The system is designed to help enterprise organizations improve document speed-to-access, security and compliance.


    Arena document management system review


    Arena offers typical document management functionality, such as letting customers track both in-process document versioning and released revisions of all documents. As a cloud-based document software platform, it's a good way to break down information silos and centralize your information streams.

    But similarly to MasterControl, its complex enterprise focus comes at the expense of usability and time to value. Slow document retrieval times and a poor search engine are noted by customers, and its layers of modules and features make it unsuitable for start-ups and scale-ups looking to build and scale their document maturity.


    4. Qualio


    The final entry on our document management systems list is Qualio - us!

    Qualio’s document management system for life science companies comes with all the features you’d expect from an industry-leading eQMS provider. Qualio is built to help customers optimize their document management systems, from periodic reviews and ALCOA+ integrity to embedding unshakeable audit readiness.




    Qualio document management software review


    Qualio's customers report an industry-leading 96% satisfaction rate on G2. Praise is particularly directed at Qualio's ease of use, with a clean, flat and intuitive interface making document management tasks quick and simple.

    Qualio's hybrid document management philosophy is focused on optimizing how both existing and new documents are controlled and managed.

    Existing documents can be given instant compliance and audit readiness thanks to flexible file format uploads, while Qualio's OneDrive and SharePoint integrations allow your colleagues to keep working on documents in familiar tools while updates are synced seamlessly into your document management system.

    And when it's time to build new documents, Qualio is the only platform in our document management systems comparison to feature fully native editing and collaboration - eliminating the need to check documents in and out of your eQMS for changes.

    Because Qualio's built to provide document management for life sciences specifically, the platform even comes with pre-built industry-specific templates for key documents like ISO 13485 SOPs and GxP quality policies - accelerating your route to a robust and audit-ready document management system!

    Document management reviews agree that if you're a growing life science company, Qualio offers the strongest document management software functionality on the market.


    Choose the best document management system


    Establishing a solid document management foundation is critically important for life science start-ups and scale-ups. There are many document management systems for life sciences companies on the market today, but Qualio continues to deliver the very best features.

    Are you ready to start demoing?