###### DOCUMENT CONTROL # Document control that keeps pace with your team #### Create, review, approve, and distribute controlled documents from one place. Version history is automatic. Every change is recorded in an immutable audit trail. Part of the Qualio compliance platform. ## QMS document control software that does the heavy lifting for you #### Challenge Document management and control can be time-consuming and laborious - especially with a paper-based quality system. From repetitive admin to chasing down signatures for approval, it can feel like you’re managing a daycare instead of building a real quality-centric culture. #### Solution Qualio provides integrated document lifecycle management software for your entire stack. Standardize with templates. Automate your QMS document control. And embed real compliance with fully digitized lifecycle management and compliant e-signatures. ### Hybrid documentation control software to suit your business - Make new QMS documents with our unique **[in-app editor](/content/blog/new-editor/index.html)**, upload files in any format, or sync them straight from your company OneDrive - Find the info you need in seconds with smart links and document tags - Build bespoke workflows for document approval, training and review to drive the best document management system - without hours of admin and teams of personnel ### Data and collaboration in tandem - Collaborate on document creation, distribution and review in real time with your colleagues - all from a single, centralized document management software system - Secure your data by setting bespoke editing, view-only and download permissions - Ensure your colleagues follow the processes you want them to with automatic version control ### Airtight QMS document control with 100% compliance - Meet your electronic record requirements with compliant and binding e-signatures - Replace risky and insecure paper records with a fully controlled documentation control software platform - Integrate with OneDrive to embed document compliance even as your colleagues work in other systems ### Build a QMS document management system with automatic best practice - Meet ALCOA+ integrity principles with complete document lifecycle control - Trace all document activity with incorruptible audit trails - Demonstrate total compliance to your auditors with a purpose-built ISO document management software platform ### Document management resources #### The case for document management Read our whitepaper to learn the 6 key reasons your life science business should embrace software for document control. [Get my whitepaper](/content/resources/life-science-electronic-doc-management-whitepaper/index.html) #### Document management datasheet Dive into the core functionality of Qualio's documentation management software and the operational benefits you can expect. [Get my datasheet](/content/resources/document-management-datasheet/index.html) ## The ultimate guide to document management software Regulated companies with highly structured information flows are increasingly turning to document management software to make their lives easier. It's little wonder. Document management software and document control software systems offer automation, traceability and control far beyond traditional methods like paper and spreadsheets. And because document control is a critical component of modern quality management, it's crucial that regulated organizations, such as life science companies, get their document processes sharp in order to unlock optimal quality across the rest of their operations. In fact, companies embracing QMS document control in tools like [Qualio](/content/site-root.html) report more than a 90% reduction in their admin burden, as well as faster, easier audits and more time for value-add continuous improvement tasks. The knock-on effects of giving your business the best document management system can be dramatic. ### Why is document management software so valuable? _Your employees lose at least half an hour every single day just searching for the information they need to do their jobs._ Connecting your employees to trusted, rapidly accessible information is one of the fastest ways to boost company productivity. Weak document integrity, and multiple circulating versions, mean the wrong instructions are followed, processes are leaky and inconsistent, and accurately sharing trustworthy information becomes almost impossible. Document management software eliminates these challenges. And if you're in a regulated [GxP](/content/blog/gxp/index.html) environment, storing documents in a structured digital environment is the perfect way to set guardrails and guarantee constant, long-term compliance. ### How to choose documentation control software How do you choose the best document management software for your specific business needs? Having a set of standard questions to ask yourself and potential vendors is the best way to start the process. It's also important to note that document control software is often bundled into a broader set of functionality, such as a [quality management system software](/content/product/index.html) platform. Qualio's [12 questions to ask before you buy an eQMS](/content/resources/questions-to-ask-eqms/index.html) is a good way to pinpoint your company's exact documentation management software requirements: _What do you want to achieve?_ _Does it meet your industry needs?_ _Does it meet your organization’s size and scaling needs?_ _How customizable and flexible is it?_ _What 's your budget?_ _How long will it take to get up and running?_ _Will it support your compliance needs?_ _Are onboarding services included?_ _What’s the support like?_ _Will your important data be secure?_ _Will it help you go paperless?_ _Is it easy to use?_ ### What is document management software? Document _management_ software and document _control_ software are usually used interchangeably as terms. In short, software for document control is any digital system that offers dedicated functionality for managing the so-called 'document lifecycle'. The document lifecycle of creation, collaboration, distribution and archiving of a document is an important cornerstone of modern quality and compliance, because documents offer a standardized blueprint of how your company works. Document management software should offer features like: - Digital and online 'paperless' document storage, often in the cloud for remote access - Collaboration features, like inline commenting and mentioning to support input from multiple owners - Version control, e-signatures and audit trails for compliance with electronic record regulations like [GDocP](/content/blog/gxp-pharma/index.html) or [FDA 21 CFR Part 11](/content/blog/printable-21-cfr-part-11-compliance-checklist/index.html) - Permission control, so only certain users can view a particular document - In-app editing and updating, to reduce reliance on 'checking into' and 'checking out' of non-compliant systems like Word The best document management system for your business should offer all these features. ### What documents can you manage with QMS document control software? Documentation control software should empower your business with the freedom and flexibility to manage any kind of document you need to. QMS document control and ISO document management software is typically deployed for storing and distributing critical quality and compliance documents, such as: - Policies - Standard operating procedures (SOPs) - Work instructions - Organizational charts - Process diagrams - Audit records - Equipment and calibration records - Medical device design documents And more. ### Document insights and analytics Another key benefit of documentation management software is its ability to provide bird's-eye visibility of how your documents are really being built and used day-to-day. Document platforms unlock powerful [compliance analytics](/content/product/quality-analytics-software/index.html) such as: - Who has read, been trained on and signed off on a document - Document cycle times and approval timeframes - Statuses of documents across your business: live, in draft, archived, and so on - Due, overdue and completed document training - Open actions and bottlenecks with responsible personnel ### Do you need document management software? If you've ever struggled with any of these pain points, document lifecycle management software could be right for you: - Employees struggling to find information (or losing it) - Duplication of work and unnecessary copying of documents - Awkward filing cabinet retrieval trips while an impatient auditor waits - Physically large/confusing paper document storage areas with manual upkeep requirements - Long email chains with back-and-forth attachments and uncontrolled document versions ### The return on investment of document control software Investing in the right QMS document control can deliver transformational ROI. The average company spends $20 on labor to file one document. Another $120 locating a misfiled document. And $220 replacing a lost document. ### The pros and cons of document management software Before you act, it's worth weighing up whether documentation management software is the right choice for your business. #### Pros of document management software - Stronger compliance - More time for value-add - Cultural change - Integration #### Cons of document management software - Upfront cost - Training - Configuration & validation - Going paperless ### Choosing the best document management software Now you've read this far, it's time to start the exciting work of scoping out the best document management software for your company's needs. Start by working through the [12 questions to ask before you buy an eQMS](/content/resources/questions-to-ask-eqms/index.html). ## Trusted by 500+ life sciences companies ### Hear from our customers ##### “Qualio has made it so much easier to review and edit documents prior to document release. This has improved the quality of our documentation and reduced the amount of time spent on getting documents through our release process.” ###### User ###### Medical Device SME ##### ”I like the very flexible approach that Qualio offers to deal with documented types of information. A document can be basically everything from an SOP to an HR file or equipment log. This is very powerful, particularly in combination with the tagging feature.“ ###### Christian S. ###### CMC/QA Consultant ##### “The thing I like best about Qualio is how simple the documents are prepared for easy understanding by anyone who has no previous knowledge of what they're reading, be it a policy or a basic learning document.” ###### Sravya D. ###### Medical Fulfillment Specialist ##### “You can look at an SOP in Qualio, see the list of associated documents and click hyperlinks to retrieve information immediately. That’s one feature I’m greatly enjoying.” ###### Tyler C. ###### Executive Director of Quality, Linical Americas ##### “For documents, as soon as an auditor comes in they can see everything in the audit trail. Nothing is missing, nothing can be changed without it being documented - and the auditors think that is so great.” ###### Gene V. ###### Quality Manager, Cirris ##### “Qualio gives me everything in one place. You can connect or link documents to other documents and keep the traceability of any changes made or decisions made.” ###### Dragan V. ###### Software Engineer, Axiom