Understanding the Importance of Document Lifecycle Management

What are the 7 stages of the document lifecycle? Why is managing and controlling the lifecycle a critical part of a Quality Management System (QMS)?

What is the document lifecycle?

Document lifecycle: the stages a document goes through as it is issued, distributed and used in an organisation, from its creation to the moment it is archived or deleted. For high-tech and medical device developers it is the key to controlling the flow of information that ensures safe and effective product design and development.

Document lifecycle can be broken down into 7 key stages. This blog post explores how each stage can be controlled to help you streamline your product management process:

What levers do you need for effective document lifecycle management?

Document controls are the procedures and tools you’ll need for managing each stage of a document lifecycle successfully. 

Why does document lifecycle management matter?

Without the right controls in place across the document lifecycle your business risks losing vital data and organisational knowledge as it grows and changes. You face an increased risk of ‘document anarchy’. And you risk failing to comply with key standards and regulations that can cause delayed launches, product recalls and serious fines. 

What ISO standards require document lifecycle controls?

Document lifecycle management is a critical feature of the quality management requirements specified in ISO 9001 and ISO 13485 (for medical device developers). These are the standards that ensure the integrity of data and information through a product’s stages of maturity from, design, manufacture to management. These are the standards that control the quality and consistency of your output. They secure the safety and efficacy of the products you supply.

Why you need to control the 7 stages of the document lifecycle:

1. Creation

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.

2. Approval

You need the tools to approve documents prior to use so mistakes are captured and corrected.

If you can’t select individuals to review and approve documentation for finalisation, you risk releasing incomplete/inaccurate documents that can damage your business or lead to dangerous mistakes.

Remember when the UK government released a multi-million pound ferry contract with Ts and Cs obviously cut and pasted from a Domino’s pizza site? Or when the French national rail operator RFF gave the wrong dimensions for a required new fleet of trains that were too narrow for their platforms? That mistake cost RFF 50 million Euros to correct.

Or what about mistakes made in the labelling and packaging of medical devices?

Labelling errors continue to be a significant cause of medical device recalls. Analysis of FDA data spanning the years 2012 to 2023 reveals that around 8% of all product recalls can be attributed to labelling problems.

3. Storage

You need to protect vital customer data, products and business intelligence from loss or misuse. Choose a system built to the ISO 27001 standard and ensure your team are 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.

4. Distribution

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.

5. Retrieval

You need to ensure the retrieval of data and information 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.

6. Change control

If you can’t control how and by whom changes are made to documents you risk mistakes going unchecked, unauthorised work being done and projects growing out of control.

Who’s made changes to a document? Are developers working in a silo adding new functionality without authorisation? Has a potentially dangerous change to a medical device been authorised without input and approval from a cross functional team? Mechanisms for controlling engineering updates, as well as Corrective and Preventive action (CAPA) ensure critical changes are approved by the right people before they can go ahead and then reviewed to ensure they have been implemented correctly.

​​Because if they don’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 homeostasis valves did not function as intended, posing risks of delayed or failed procedures that was risked compromising 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.

7. Obsolescence

If you can’t control when and how documents are made obsolete you risk accidental document loss that could result in fines from regulators or a system stuffed with unneeded documentation.

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.

At the same time you need to be able to archive your documents and keep them available for as long as the law requires (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.

Look for flexibility in your eQMS

Choosing a document management system (DMS) with the tools to control the entire document lifecycle will help you build a quality system that can meet your organisational objectives and your regulatory obligations.

But great document lifecycle management is about having the levers to implement document controls as required without unnecessarily interfering with the flow and velocity of your development process.

The danger of ‘overprocessing’ is ever present for start ups and SMEs. Many of these businesses choose heavy duty eQMS (as used by the largest pharma companies) to guarantee their compliance with quality standards. But the level of controls and checks that these systems impose on your documentation and process from the outset can slow down a small operation without good cause.

Not every document requires the highest levels of controls to be applied to them. Different documents may require different approval journeys and will have different archiving requirements.

Choose lean tools for document lifecycle management 

The good news is you can build a quality management system that controls your documentation adequately throughout its lifecycle while not tying you up in red tape or slowing you down unnecessarily.

For this, you need LEAN document management tools like Cognidox that can help build out your own workflows and approval mechanisms in a way that makes sense to you. 

Choosing lean document management tools like these can help you build custom workflows and approval mechanisms that fit your needs perfectly. These flexible tools can adapt to your organisation's maturity and risk level, providing just the right amount of control while mirroring how your business operates.

They can manage your document lifecycle - without managing you into the ground.

Blog latest updated on 18/03/2025