GUIDE 2022

What is Document Lifecycle Management?

Document lifecycle management is the series of processes that a document goes through from creation through archiving or destruction.

For example, you've stumbled onto a document and aren't sure if it's the most recent version. Inquiring minds want to know if the document you've stumbled onto is valid and up to date. In this blog post, I detail the process that goes into managing that.

What Exactly is the Document Lifecycle?

The steps that a document travels through when it is published, disseminated, and used in a document, from the time it is created to the time it is archived or removed.

Document Management Lifecycle Stages

The document's lifespan may be divided into seven distinct stages:

  1. Creation
  2. Approval
  3. Storage
  4. Distribution
  5. Retrieval
  6. Change control
  7. Obsolescence

Here are the seven stages of the document management lifecycle in detail:

1. Creation

You risk losing responsibility and traceability around your process and projects if you don't have control over who may upload documents to your system.

Who wrote and signed off on your Quality Manual? Who created the standard operating procedures (SOPs) stated in your QMS? Are these documents created, signed off on, and held by persons who have the necessary authority and qualifications? Effective document lifecycle management offers you and future auditors confidence in the origin and authority of every document in your system. It guarantees the dependability of the documents you use on a daily basis to develop, manufacture, test, and distribute your goods.

2. Approval

You must have the tools to approve documents before they are used so that errors may be identified and remedied.

If you are unable to choose persons to examine and approve material for finalization, you risk publishing incomplete/inaccurate documents, which can harm your business or lead to harmful errors.

3. Storage

You must safeguard critical consumer data, goods, and business insight from loss or misuse.

Security concerns are all too typical in organizations that handle sensitive information. From the three billion Yahoo users harmed by data leaks in 2014 to the unexpected appearance of a stockpile of top-secret MOD documents at a bus stop in 2020. Every year, inadequate document management affects many bodies and millions of individuals.

Protect your employees, customers, and intellectual property by protecting your systems and creating protocols to limit human error.

4. Distribution

To maintain your organization's efficiency and productivity, you need the tools to publish and distribute the correct documents at the right time.

You can't properly regulate the flow of data and information in your organization if you can't strategically publish and share documents with colleagues and third parties. You risk a shambles in project management, security, and other areas.

Controlling document flow is a critical component of a lean and successful product development process. Releasing the appropriate documents to the appropriate individuals at the appropriate time in a process saves time and effort. It keeps teams focused on reducing unnecessary and confusing paperwork and delivering exactly what is required at every stage of the development cycle.

5. Retrieval

You must guarantee that data and information are retrieved quickly and efficiently.

ISO 9001 and ISO 13485 both require documents to be easily accessible to stakeholders at the point of usage.

If you can't swiftly and readily get information from a document system when you need it, hours and days can be wasted on projects, and key business knowledge can be neglected.

Ensuring that your company is indexing documents with metadata will assist your staff in finding the documents they require when they require them. It can assist avoid the loss of organizational knowledge and data in a large system's black hole. It can save you from having to duplicate labor or forward with projects without the necessary data or proof to make important decisions.

6. Change Control

If you can't monitor who and how documents are changed, you risk mistakes being unnoticed, unauthorized work being done, and projects spiraling out of control.

Who made alterations to a document? Is it possible that developers are working in silos, creating new features without an authorization? Is it possible that a potentially harmful update to a medical device was authorized without the input and approval of a cross-functional team? Control mechanisms for engineering updates, as well as Corrective and Preventive Action (CAPA), guarantee that essential modifications are scrutinized and authorized by the appropriate personnel before they can be implemented.

Effective change controls are the commercial and regulatory circuit breakers you need to safeguard your company from waste and errors.

7. Obsolescence

If you can't regulate when and how documents become obsolete, you risk inadvertent document loss, which might result in regulatory fines or a system clogged with unnecessary paperwork.

ISO 9001 and ISO 13485 necessitate that you be able to recognize the difference between an old document and the most recent version of the documents in your system. This saves time, confusion, and blunders. Simultaneously, you must be able to preserve your documents and keep them accessible for as long as the law allows (without slowing down the performance of your system or costing the earth in storage fees).

Choosing a document management system (DMS) that includes capabilities for controlling the full document lifecycle will assist you in developing a quality system that will fulfill your organizational objectives as well as your regulatory responsibilities.

Frequently Asked Questions

What tools are required for efficient document lifecycle management?

Document controls are the methods and technologies required to properly manage each step of a document's lifecycle. Tools to do this include Squibler.io, Confluence, Notion, and ClickUp.

Why is document lifecycle management important?

Without the proper controls in place throughout the document lifecycle, your company risks losing critical data and organizational knowledge as it develops and evolves. You are at a higher risk of 'document anarchy.' You also run the risk of failing to meet crucial standards and requirements.

Document lifecycle management and compliance?

Document lifecycle management is a significant component of the ISO 9001 and ISO 13485 quality management criteria. These are the standards that maintain the integrity of data and information as a product matures through the stages of ideation, design, production, and maintenance. These are the guidelines that govern the consistency and quality of your work. They ensure the safety and effectiveness of the things you provide.

 


If you are new to understanding the document lifecycle and looking to learn more, we recommend taking our Technical Writing Certification Course, where you will learn the fundamentals of managing technical documentation.