What are the seven stages of the document lifecycle, and why is lifecycle essential to an effective Quality Management System (QMS) in the medical device sector?
What is the document lifecycle?
The document lifecycle refers to the complete journey a document takes within an organisation - from its initial creation through to its review, approval, distribution, active use, and finally to its archiving or deletion.
For high-tech and medical device developers, document lifecycle control provides for the seamless flow of information within a company that, ultimately, ensures safe, effective product design and development.
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TL;DR summary: Document lifecycle can be broken down into 7 key stages. Jump to: |
Document lifecycle management is a critical feature of the Quality Management standards ISO 9001 and ISO 13485. It is also a mandatory requirement of the FDA Quality Management System Regulation (QMSR), the EU MDR (medical device regulation).
If you can’t control your document lifecycle, your organisation can quickly lose oversight of critical procedures and records, compromising project success and product quality.
When versioning is unclear, or access to files is unrestricted, teams may create, edit, or use the wrong documents - leading to confusion, duplication, and mistakes across your business.
This breakdown in control - often described as "document anarchy" - risks data integrity, security, and project breakdowns.
Long term consequences for your business might include launch delays, product failures, wasted money, regulatory penalties, and costly recalls.
In the world of medical device innovation - document anarchy in the design, development, manufacturing and project management phases can all result in serious harm to the professionals and patients who use your products every day.
Who authored and approved your Quality Manual? Who defined the SOPs outlined in your QMS? Are these documents set up, signed off and owned by people with the appropriate authority and qualifications?
Effective document lifecycle management gives you and future auditors confidence about the provenance and authority of every document in your system. It ensures the reliability of the documents you use every day to design, manufacture, test and release your products.
Why it matters: Without control over who can add documents to your system you risk losing accountability and traceability around your process and projects
Who can approve key quality documents in your system prior to their use? Who is required to sign off each phase of project development, so mistakes are captured and corrected before they can escalate?
Bausch & Lomb’s release of their contact lens solution product is a stark example of what can go wrong without effective approval processes in place.
Due to inadequate design validation and a failure to catch a chemical flaw during document and formulation review, the company launched a product in 2006 that contributed to a global outbreak of fungal eye infections. The issue led to severe injuries, a Class I FDA recall, and over $250 million in legal settlements.
What went wrong? Critical documentation and testing data weren’t properly reviewed or approved before release. The flaw remained undetected until it reached consumers — when it was far too late.
Why it matters: If you can’t select the right individuals to review and approve documentation for finalisation, you risk releasing inaccurate documentation that can lead to dangerous mistakes
How does your system protect vital customer data, business intelligence or IP from loss or misuse?
Is your document management process compliant with the ISO 27001 standard? Is your team fully trained in cybersecurity?
Security issues are all too common in organisations handling sensitive medical data.
Device manufacturer Artivion recently faced a serious cybersecurity breach compromising their confidential files (TechCrunch). Human error also remains a leading cause of data loss, with studies indicating that up to 95% of cybersecurity breaches are due to user mistakes (CyberNews). Additionally, intellectual property theft poses significant risks. Alleged misappropriation of cancer therapy secrets is the reason AbbVie is suing BeiGene (Reuters).
Why it matters: Protect your workers, customers and your IP by securing your systems and developing procedures to mitigate against human error.
You need the tools to publish and share the right documents at the right time to keep your organisation efficient and effective.
If you can’t selectively publish and share documents with colleagues and third parties you can’t effectively control the flow of data and knowledge in your organisation. You risk chaotic project management, security and other lapses.
Controlling document flow is a key part of an effective and LEAN product development process. Releasing the right documentation to the right people at the right time in a process prevents wasted time and effort. It keeps teams focused on minimising extraneous and confusing documentation, delivering exactly what they need to, at every point of the development cycle.
Why it matters: Ensure colleagues and partners only see relevant, accurate documents, reducing confusion, errors, and security risks.
How do you ensure the retrieval of data and information from your system is fast and efficient?
Both ISO 9001 and ISO 13485 require documents to be readily available for stakeholders at the point of use.
Ensuring your business is indexing documents with metadata can help your team find the documents they need when they need them. It can help prevent the loss of organisational knowledge and data in the black hole of a sprawling system. It can prevent you having to duplicate work, or proceeding with projects without having the right data or evidence in place to justify critical decisions
Why it matters: If you can’t retrieve information from a document system quickly and easily when required you can lose hours and days in project time.
Can you control how and by whom documents in your systems can be changed?
If not, you risk SOPs changing without proper scrutiny, design mistakes going unchecked, unauthorised work being done and projects growing out of control.
Robust document controls for engineering updates and CAPA ensure that critical changes are reviewed and approved by the right people before they are implemented. They should also ensure they are checked afterwards to confirm they were completed correctly.
Because if they aren’t - the worst can happen.
For example, in 2022 the FDA found Merit Medical Systems modified a product component without following the required change control and approval process. This lead to an update that was not properly tested or documented before implementation. As a result, their hemostasis valves did not function as intended, posing risks of delayed or failed procedures that compromised patient safety. This failure in engineering change management prompted an FDA Class I recall.
Why it matters: Effective change controls are the commercial and regulatory circuit breakers you need to protect your business from waste and mistakes.
Can you ensure obsolete documents do not remain in circulation - but are still available for review in audit?
ISO 9001 and ISO 13485 require that you easily distinguish between an obsolete document and the most current version of the documents in your system. This prevents wasted time, confusion, and mistakes. The Cognidox system, for example, ensures draft and obsolete documents are watermarked to ensure their status cannot be mistaken.
Many regulations stipulate you should archive your documents and keep them available for as long as the law requires. This can be hard to manage, without slowing down the performance of your system or costing the earth in storage fees.
Why it matters: Properly handling document obsolescence prevents confusion, meets regulatory requirements, and keeps your system LEAN
Implementing a digital document-lifecycle structure early in your development process is one of the most effective ways to build a QMS that can scale. By defining - from the start - how documents are created, reviewed, approved, updated and retired, you create a reliable digital foundation that supports both compliance and faster growth.
A modern digital eQMS system with end-to-end lifecycle control ensures your documentation stays accurate, secure, and audit-ready as your organisation evolves.
It reduces manual effort, speeds up decision-making, and protects your intellectual property in ways paper-based or loosely managed systems cannot.
But too many eQMS platforms impose rigid workflows and unnecessary complexity that slow teams down rather than enabling them.
Heavy-duty systems built for established life-science companies, can force smaller enterprises into ‘overprocessing’ - requiring excessive sign-offs, duplicated steps, or full change-control cycles for updates that pose minimal risk.
Instead of supporting quality, these systems often make document control burdensome, bureaucratic, and disconnected from the pace of real development work.
A flexible eQMS system like Cognidox can help medical device companies meet these challenges with LEAN, configurable tools designed to support rather than strangle your team with digital governance requirements.
With fine-grained user permissions, you control exactly who can create, edit, approve, and view each document. This ensures that sensitive or regulatory-critical content is only handled by authorised personnel, while still enabling easy access for those who need it.
Cognidox encourages a logical, hierarchical folder structure combined with powerful metadata tagging. This makes it easy to organise drafts, manage document versions, and distinguish between working copies, released issues, and obsolete records. Nothing gets lost. Everything is traceable.
Whether you’re sharing internally across teams or externally with partners, auditors, or regulators, Cognidox gives you full control. Use secure extranet functionality to publish only what is needed, when it’s needed - and keep a full audit trail of who accessed what, and when.
Cognidox doesn’t force you into a rigid system. It provides a digital framework that supports your way of working, whether that’s agile, formal, hybrid, or evolving.
You stay in control of your documentation, your processes, and your compliance posture.
Cognidox manages your document lifecycle - without managing you into the ground.
Last updated on 25/11/2025