Understanding Document Management vs Document Control

Difference between document management and document control

For some companies simply managing their documentation is enough to support their business goals. But others need to control their documents to achieve their quality objectives. So, are you ‘just managing’, or do you need more document control in your life?

What is document management vs document control?

Document management is about storing, sharing, and tracking documents to improve the efficiency of your operations. But document control is about marshalling the flow of knowledge and data in your organisation. It’s about controlling how information, people and processes interact to drive the best quality outcomes for your products. Document control is a major feature of quality management standards like ISO 9001 and ISO 13485.

For those working in regulated industries, controlling documentation is a requirement for selling their products and services around the world.

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Where are you on the ‘pyramid of information management maturity’?

What capabilities do you have - and what do you need?

A model for understanding your ability to control critical data and information is the ‘pyramid of information management maturity’. The nearer the top of the pyramid you are, the more you are capable of information governance, quality management and lifecycle management: 

Pyramid of information management

File sharing is not the same as document control

At the lowest level, a company with a need for collaboration support can solve its problem with a basic, free file-sharing solution such as Dropbox or Google Drive.  

These can be no cost (or low cost) but the emphasis is very much on storage and collaboration. These collaborative tools offer very basic version control, by just rolling back or forward in a limited number of steps. More like ‘undo’ than proper version control.

However, it should be noted, in the last few years, Google, Microsoft One Drive, DropBox and Box have started offering paid packages with many more document management features.

What level of control do you need?

File Sharing Vs Document Management Vs Document Control

 

 

File Sharing

Document Management 

Document Control 

Software examples

Dropbox, Google Drive (basic low cost/no cost versions)

Advanced versions of Google Drive, OneDrive, Dropbox Business, SharePoint

MasterControl, Veeva Vault,  Cognidox

Focus

Document storage and basic collaboration

Document storage,  management and collaboration

Data control, information management and document collaboration. Complete document lifecycle control, ensuring regulatory compliance

Version Control

Basic, limited "undo" functionality

Automatic version numbering, version history, version restoration and archiving

Strict version control with full audit trails, showing editing history

Workflows

Typically no workflows

Basic workflows

Complex workflows for review, approval, and submission

Security

Basic access control

Advanced access control

Advanced, granular access control and security features

Indexing

Basic folder structure

Basic metadata tagging and document hierarchies (however -Sharepoint excels at data storage and indexing)

Advanced data-structuring metadata tagging and automated indexing

Compliance Features

None

None

Extensive GxP compliance and regulatory features - templates for non-conformance reporting,  CAPA etc 

How file sharing platforms became document management systems 

Spotting the commercial opportunity, Dropbox and the rest have become more than simply file-sharing platforms and morphed into something like document management systems.

But they’re still falling short on delivering granular control throughout the document lifecycle that is required for an effective quality management system (QMS). 

What about SharePoint?

Moving up a level, a company may achieve Document Management maturity status by using a repository-based tool like SharePoint.

It is often said that SharePoint is synonymous with document management. But Document management with SharePoint is often reduced to providing lists of documents stored on a server, admittedly with version control, but often with not much more than that.

Why SharePoint isn’t working

Many companies start and abandon SharePoint DMS projects, which seems to come down to three critical variables:

  1. The project is run by IT for Marketing with poor buy-in from other users. This leads to an imposition of the solution on the end-users, and poor adoption (often less than 30%) is the result. The company is now in a bad place: it has a ‘solution’ but nobody is using it.
  2. SharePoint requires extensive customisation and is not much of an out-of-the-box application, so consultants are brought in to help. The project becomes a set of IT rather than business challenges, and even integration with other Microsoft products becomes a negative experience.
  3. SharePoint shows its roots in FrontPage Designer and shared network drives. It is just a cluster of intranets for individual teams that have a list of documents they like to access. If one team wants a document from another, it gets cloned into their site. More often than not, it doesn’t replace the file share, so the problem of document duplication gets worse, not better.

But isn’t SharePoint ISO compliant?

It’s well known that ISO places no explicit requirements on the DMS software itself, so Googling "is SharePoint ISO compliant" will yield no definitive answer. What you might find, however, is that the case studies and SlideShare presentations on "how we did ISO with SharePoint".  These usually involve SP plus extra software from the 3rd party SP solution partner ecosystem.

So, what is Document Control?

Document Control is a higher maturity level above document management and is essential to standards such as ISO 9001 and ISO 13485. The key capability of a great document control system is that it has a document lifecycle model that is animated using digital tools. 

In contrast to document management software, document control systems are designed to help you meet regulatory requirements (such as GxP compliance). But it should be noted that some do this in more proscriptive ways than others. 

Click here to book a free demo of the Cognidox eQMS - document control at your  fingertips

7 essential elements of a document control system

1. The system should support advanced document versioning

The system ensures a robust document control process maintaining a single master version of each document (with digital watermarking) to eliminate confusion around duplicates or outdated versions.

2. There is an audit trail and a full activity history available 

This goes beyond mere event logs; it should be possible to easily view the activity history around every document in your system even when it was in a previous version.

3. Search and information ‘discoverability’ is essential

If users have to navigate through a maze of folders to locate the document that is of interest, then time is wasted and vital information and data can be lost or ignored.

4. Documents are unique, categories should be dynamic

It should be possible for a document to ‘exist’ in more than one place without being duplicated. Without that, things can get very confusing very quickly. As one SharePoint user pointed out to us:

"Because of the hierarchical nature of the structure, duplicate documents often exist on our system as staff are unsure what exact folder to upload the document to"

5. The search engine should be able to index every text element

This includes metadata and text in image files as well as the text-heavy Word and PDF file. Results should then be presented according to their relevance to the search string.  Dedicated document control systems offer highly sophisticated search functions that will ensure you can always find the document you’re looking for.  It’s hard to replicate that kind of discoverability with SharePoint (in case you missed it: this article charts the rise and fall of Microsoft Search)

6. Information security is paramount 

Standard document access control systems are often still rooted in simple read or read-write permission rights. Much more is needed for true document control. Once the user’s right to access a document is established, it then becomes necessary to determine what the user can do with the document. Can they approve it?  Can they share it? Can all the ISO 27001 standards be maintained by the system? Document control systems should give you complete granular management over access and edit rights so that can never lose, leak or overwrite critical data.

7. Ease of use and installation is a major success factor

If you can get a document control solution up and running quickly you can start to engage the business and encourage customisation. Therein lies the path to 100% adoption.

Conclusion

Document management is not the same as document control.

But it's always the case that the right software solution depends on your requirements. If you are kicking around a few ideas for a startup, there is no reason why file-sharing won't meet your needs. It's when you reach the heights of having to justify the wasted time of tens or hundreds of employees or having to meet QA / FDA regulatory compliance and other governance for supply chain management that you begin to understand the difference between that and document control.

Cognidox Medical Device FDA

Blog post updated on 20/11/2024

Tags: Quality Management System, Document Management and Control

Paul Walsh

Written by Paul Walsh

Paul Walsh was one of the founders of Cognidox. After a period as an academic working in user experience (UX) research, Paul started a 25-year career in software development. He's worked for multinational telecom companies (Nortel), two $1B Cambridge companies (Ionica, Virata), and co-founded a couple of startup companies. His experience includes network management software, embedded software on silicon, enterprise software, and cloud computing.

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