11 Essential Features of Medical Device Document Control Software

Inflexible SOPs, complicated interfaces, training and maintenance requirements. Traditional document control software can be too clunky and bureaucratic for many medical developers. Scaling companies need a solution that’s more flexible; something that’s customisable, robust and effective - but won’t slow you down as you head towards launch.

Everything you need - nothing you don’t

When it comes to medical device document control you need a solution that gives you everything you need and nothing you don’t. A system that can cut out the wasted time of a manual review and approval process, help you strip out unnecessary bureaucracy from the way you work, and keep you laser-focused on producing the documentation that you need to drive your product forward.

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11 key features of medical device document control software

1. Flexible workflows

One size fits all workflows won’t work for a scaling business. The right document control software gives you complete control over workflows for different document types so you’re always working in a way that suits you. It helps to have templates for mandated SOPs such as complaint management, non-conformance reporting and CAPA - but you still need the ability to configure them to match the way you want to work. Flexibility with workflows is critical if you don’t want to be tied into a vendors’ way of doing things.

2. Control over meta-data

Metadata helps you categorise, search, filter and report on documents more effectively. The right solution will let you add metadata as needed, creating unique fields, categories and keywords to your system, linking documents, speeding up search and audit, ensuring vital knowledge and data does not get lost or ignored. In a powerful document control system meta-data can even be used to trigger process workflows helping you customise your solution in ways that always answer your specific project needs.

3. Seamless knowledge sharing

Document controls help you build a trusted hub of information that everyone in your business can refer to for guidance and training.  The right solution helps you make all training and process documentation available in the most suitable format for its purpose (from written documents, photos, videos, to flow diagrams).  Document controls ensure this material is always usable, up-to-date and available whenever and wherever it is needed.  

4. Intelligent review and approval tools

Intelligent rules for review and approval makes information flow through at the right time to the right people - this is important in med dev where a huge amount of mission critical data is shared daily between teams .  Great document control software makes this process as LEAN and slick as possible through:

• Conditional routing options
• Parallel routing options to send documents to a group or named individuals all at once
• Reminders to notify users about upcoming and overdue document approvals
• Automation of periodic review of key documentation (SOPs etc)

The right solution will ensure your people and their teams are alerted when they need to act, It will automate review processes and offers e-signature approvals to eliminate the long waits for multiple sign-offs that can haunt a manual process. It strips back unnecessary communications and the background noise that can distract a team from getting work done.

5. MS Office Integration

Word and Excel are the standard for creating documents in most companies. That’s why you want to look for a document control system that integrates effectively with Microsoft Office. Your system should let you build out required documentation using MS documents, so that updates and changes can be made quickly and easily.

6. Document phase-gating for design controls

Medical device developers need to phase gate their design process for ISO 13485 and FDA Part 820 compliance. This means marshalling lots of complex documentation to support cycles of planning, execution and review; continually validating deliverable against designs and user requirements.  

‘Document holders’ should be used to assemble required documentation for each phase of a development process (including user specs, engineering designs, validation matrices), triggering approval sequences when the right documents are in place and completed. When approval is given from all stakeholders, documents can then be formally published and the next phase of the project started.

Automating design controls and creating vital STOP/GO moments in your process, optimise your use of resource, minimise errors, and ensure your whole team is always focusing their effort where it’s needed most. 

7. Robust version control, change request and obsolescence processes

Change request and document versioning both need their own customized workflows. These processes should drive consistency, efficiency and control to ensure:

• Nobody can make unauthorised changes to documents
• There is only one master version of every document visible in your system at any time
• New documents replace old ones and previous documents are held until they are superseded
• Documentation no longer required can be labeled obsolete and archived correctly
• Every change is captured in an audit trail to track changes between versions

8. E-signatures built-in

FDA Part 11 and MHRA’s GXP require changes and approvals to quality documentation in a digital system to be signed off with e-signatures. These e-signatures should be 

• Controlled by administrators to ensure they cannot be misused or falsified
• Unique to individual
• Authenticated in certain ways every time they are used

Records of sign-off, including the date and time of approval, as well as the identity of the signatory, should be automatically added to a documents in the audit trail. 

The right document control software shouldn’t rely on expensive third-party digital signature integrations but should have a compliant solution built-in.

A 21 CFR Part 11 checklist: 7 key FDA e-signature requirements

9. Traceability

With the right document controls in place, you have should complete accountability and traceability throughout your product development process.  You should be able to see the details of every change made to every quality document in unalterable audit trails. In medical device development this is essential so that the source of non-conformities in products can be rapidly traced and corrected. 

As medical device scandals such as PIP and Theranos continue to break and force changes in legislation - companies need to ensure they have complete transparency around process, clinical evidence and compliance.  Not only will  reassure investors that their the inventions are safe and efficacious.

10. Forms should come as standard

A great document control system should let you set up forms to automate mandatory SOPs such as CAPA, Change Control, training attestation, complaints and calibration.  These forms should be templated, but flexible enough for you to edit, creating your own drop-down menus, labels, free form boxes etc, so you’re capturing the information you need to drive your unique  process as efficiently as possible.

11. Flexibility and scalability

The right software tools can let you build out compliant ideation and design processes that work for you

The medical device developer Coalesce used their document control software to create a repeatable development process that built compliance into ‘the way they do things’ - but in their own unique way:

Coalesce moved from an Excel based QMS to a digital QMS and gained ISO 13485 within two months of launching the solution.  They used flexible document control tools to implement their own stage gating regime, documentation structure and design control system creating a unique and repeatable development template for product success:

“​​we have developed a design process which ensures that design controls are established from the outset… This investment into understanding the parameters that affect critical quality attributes during the early stages of a project, mitigates risks during the later stages of technical transfer to manufacture, and leads to robust, approvable devices.”

The phase gates and other controls imposed allow their team to generate the required technical documentation for regulators, (such as their Design History File) as they complete each stage of a project.  

Conclusion

The right document control software supports the unique way each business works, giving them the tools they need to shape their own process and repeat their success over and over again.

It doesn’t have to be expensive or prescriptive in the way it works to meet the regulation.  Your document management solution can be a LEAN, mean, compliance machine that scales with you and lets you define the way you want to work.