A Quality Management System right-sized to your needs
Digitise your document control
Phase gate and document your entire design process
Fast and secure information management
Ensure oversight and control with graphical business management
Detect, correct and prevent quality failures
Integrate FDA and ISO 13485 compliant e-signatures into your eQMS
Monitor and manage supply chain quality
Tracking and self-attestation made simple
Change control when it matters most
No obligation live
60-minute demo
Cognidox comes in a range of subscription models to suit the needs of our users. Peruse our pricing plans to find the best and most affordable plan for you and your team, whether you are from the high tech, medical device, IVD or Life Sciences sector or a larger enterprise.
Please choose a day and a suitable time for your Cognidox demo. We look forward to speaking together soon.
STANDARD |
PLUS |
ENTERPRISE |
Pricing Bands |
|
Pricing Bands |
STANDARD |
PLUS |
ENTERPRISE |
Monthly cost per user - First 25 users |
£25 |
£30 |
p.o.a. |
Monthly cost per user - User 26-100 |
£15 |
£20 |
p.o.a. |
Monthly cost per user - User 100+ |
£10 |
£15 |
p.o.a. |
Minimum users: |
20 |
20 |
100 |
FEATURES - hover over for more info |
FEATURES - hover over for more info |
|
- Document Management SystemDocument Management SystemThe core powerful features of the Cognidox Lean Document Management System. |
- Document controlDocument controlISO standards-compliant procedures for information governance. Document control procedures are a crucial requirement of ISO 9001, ISO 13485, ISO 27001, FDA 21 CFR Part 820 and most other quality certification standards. You don’t need an electronic document management system to comply, but having one makes it far easier to achieve compliance. Cognidox has helped many companies in this task and has often elicited comments from external Auditors that it is the best document control solution they have ever seen. Companies use it as a place to store information about Audits, Change Control, Corrective & Preventive Actions, Product Quality, and more. |
- WorkflowsWorkflowsBusiness process documents can be routed to users for their action. Set up flexible routing rules based on type of request, document type and security profile. |
- ReviewsReviewsMultiple ways to review documents. As well as shared notes, you can provide comments on the document review page and you can upload new files such as tracked changes word documents. Other review types such as formal review meetings and external feedback are available. It is also possible to check out a document while the reviews are coming in to prevent a new draft being created. |
- Shared notesShared notesAllows teams to add notes to a pdf of a document. Notes are initially private but once shared they are available to all other reviewers of the document and are saved in the document review history. Allows a document owner to see all reviews in one place. Authors often need to work on the new document version offline. To help an author with this, Cognidox allows notes to be exported to a spreadsheet that includes the document pages. |
- ApprovalsApprovalsFlexible approval rules. Set up approvers based on categories, document types or just individual documents. Single or multiple approvers or a set number from a pre-defined group. |
- VersioningVersioningEvery draft and approved version of a document is held in the system along with every review comment and approval history. |
- NotificationsNotificationsAutomated email reminders for when document reviews are overdue. Flexible user based notification filters. Weekly reminders of outstanding tasks and more. |
- FormsFormsAdministrators can create HTML forms which can then be assigned to categories. Forms can consist of any number of administrator defined fields and rights to create a form can be defined. Users filling in a form will create a new document in the form category. |
- TemplatesTemplatesCreate new documents from company-wide or category-specific templates. |
- Pre-filteringPre-filteringPre-filtering of MS Office files will change both the document properties and the values embedded in the visible document, without requiring a macro or update to change the fields. Mark your document Draft, Approved, and include the document part number, etc. |
- Enterprise searchEnterprise searchEnterprise search platform for relevance-based full-text search. Also search by meta-data and document attributes. Perfect for document findability. |
- Document analyticsDocument analyticsTrack internal usage or set up a goal for a particular document you want people to view. |
- SecuritySecuritySecurity profiles applied to document sets or to categories provide very fine-grained control over who can see documents, and what further rights they have to change them. |
- Product lifecycle integrationProduct lifecycle integrationOur DNA is in product development and you will find multiple tools that will assist in decreasing waste and getting your product to market on time and on budget. |
- Development gate controlsDevelopment gate controlsUse of Document Holders to create a set of linked documents that can form gate requirements for approval. The Document Holder is a controlled document that can't be approved until all of the documents that are contained within it are approved as well. A great way for C-Level managment to have final say on whether a product development moves onto the next phase. |
- Release ManagementRelease ManagementDocument Holders are perfect for listing the components of a product release and controlling publishing to partners. Specify fixed issue numbers or keep it dynamic using the Latest and Approved tags. For example you can group together release notes, data sheets, software code and hardware specifications in one controlled document. Also, build an end-to-end software release tool-chain with integration for code version control, bug tracking and software build tools. |
- Private WorkspacesPrivate WorkspacesAbility to compartmentalise areas of Cognidox so only authorised users are aware of existence. |
- Limited Access PartnersLimited Access PartnersCreate private workspaces for open innovation partners such as contractors, content writers, etc. Provides all Cognidox features but a limited view of document categories. |
- Policy managementPolicy managementAutomated acknowledgement that employees have read and accepted employment policies. Policies can be repeated on a rolling schedule. Great where you need to demonstrate that employees have been actively informed and understood policies. |
- Email supportEmail supportSuper-responsive email support. |
- Online training resourcesOnline training resourcesFull suite of training videos and manuals grouped by type of user. |
- Business Management SystemBusiness Management SystemCreate a Business Management System as a set of web pages. Create your own intranet that captures how your company creates and delivers products or services to your customers. No web development skills required - just utilise common tools such as Visio and other standard MS Office applications. |
- Self managed IntranetSelf managed IntranetWe provide the set up files and initial templates to get you going. Easy to add and remove pages - your only limit is your imagination. |
- Visio to webpage conversionVisio to webpage conversionDesign pages with MS Visio with hyperlinks to other documents and save in Cognidox. Auto-conversion tools will create a svg version (Scalable Vector Graphics) that means your Visio diagram can be viewed as a fully navigatable web page. |
- Integrated with DMSIntegrated with DMSEvery page of your Intranet system is a controlled document in Cognidox. Completely integrated with no need for separate modules. |
- MS Office integrationMS Office integrationSave work directly from Outlook, Word, PowerPoint and Excel into the Cognidox document repository. Clone or compare Word documents to save time and see differences. |
- PluginsPluginsExchange data directly with Engineering, Sales and Help Desk tools such as Subversion, SugarCRM and OTRS. Use JSON to create data mashups or use the SOAP API for integration. |
- Dedicated virtual machineDedicated virtual machineA dedicated virtual server with your own operating system and dedicated physical processing capacity and disk resource all managed by Cognidox on your behalf. A choice of data centres around the world to choose from. |
- One to many online trainingOne to many online trainingPersonal training over video conferencing provided as part of your onboarding. We run Administrator training courses and End User training courses. Also possible to provide additional training as required on specific functional areas. |
- Authentication on approvalAuthentication on approvalFDA 21 CFR Part 11 compliant and GxP complaint authentication on approval. Requires users to input username, password, role, reason for signing and location when approving documents (requirements fully configurable by client). We also offer the option to use an authenticator on an approver's mobile device for extra flexibility and security. |
- Approval manifestsApproval manifestsA PDF Approval Manifest page is added to the PDF of the approved document clearly detailing who signed it, their title, the date and the meaning of the signature (e.g. verified or approved). The Approval history is also detailed showing all previous approved versions, who they were issued by, their current status (e.g. superseded) and when they were approved. Meets the signature manifestation requirements of FDA 21 CFR Part 11 and GxP data integrity guidelines. |
- DocuSign integrationDocuSign integrationIn addition to our integrated e-signatures, Cognidox also provides fully featured 'send to DocuSign' functionality. This is great for contract management or in cases where you do not wish to use the inbuilt Cognidox functionality to sign off documents. |
- Software validationSoftware validationA software validation pack to assist customers to validate their use of Cognidox in relation to medical device regulatory requirements. The pack includes a Validation Report, an IQ template, a PQ template, a completed PQ-OP example and test specifications & results. |
- Single sign-onSingle sign-onSingle sign-on using SAML (cloud & on-premise) / Creation of users or groups from LDAP & Active Directory (on-premise) |
- On premise optionOn premise optionFor organisations that want to have total control over their IT infrastructure we support deployment on customer servers behind the corporate firewall. |
- Clustered serversClustered serversClustered servers allow multiple Cognidox nodes to be widely geographically distributed such that local users send and receive files from their local server, rather than from a remote server. In addition to providing faster local access, clustered Cognidox nodes provide additional data-resilience in the event of hardware failures. |
- ExtranetExtranetAn instant, cloud-based web portal solution. It saves you from having to make your own web hosting arrangements, and it’s a fully-managed service so you can be freed from monitoring and maintenance tasks. Includes a content licensing & publishing engine for sharing files with suppliers, partners, customers, etc. Instead of a lengthy and expensive “consulting” period, we will customise the look and feel to match your corporate brand within hours, so you can get value from your extranet within days. |
from £3,000 p.a. |
from £3,000 p.a. | p.o.a. |
- Enhanced DR solutionEnhanced DR solutionA Cognidox Disaster Recover 'DR' box is your own ‘mini Cognidox’ on your own equipment and takes nightly syncs of your database and files. This provides you with peace of mind that you can continue to use Cognidox and access your own data in the unlikely event that a major disaster occurred. This is a fully functioning 1 user licence on-premise system that mirrors your files that are held in the cloud application. |
£3,000 p.a. |
£3,000 p.a. | p.o.a. |
- Dedicated test serverDedicated test serverA dedicated Cognidox test server which offers organisations a ‘sand box’ to test in, train users in and run tests on new software releases without impacting your main Cognidox system. |
£2.400 p.a. |
£2,400 p.a. | p.o.a. |
Notes:
Users are sold in blocks of 5. No restrictions to adding users between billing periods.
All packages billed quarterly in advance;
Discover how Cognidox can help you build products better and faster
We'd love to show you all the ways our Lean DMS can support you to create an efficient, sustainable product development process. Organise a demo by booking into our live calendar now.
Book a no obligation live 60-minute demo and discover if Cognidox is the right fit for your business.
Receive instant blog updates, straight to your inbox
Copyright 2024 Cognidox Ltd | Company Number: 06506232 | VAT number: GB 930970714