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.
Ready to take control? Download our guide to digital
document control for medical device developers
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 in information governance, quality management and lifecycle 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.
This means: document version control workflow automation, digital signature integration, augmenting the collaboration tools that have always excelled at. In offering these tools One Drive and the rest are becoming more than simply file-sharing platforms and morphing into something more 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.
The value of Document Management System for sustainable product development
Is Document Management right for you?
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 use and abandon SharePoint DMS projects, which seems to come down to three critical variables:
- 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.
- 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.
- 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" usually involve SP plus extra software from the 3rd party SP solution partner ecosystem.
What is Document Control?
Document Control is a higher maturity level above document management and adheres 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.
Visualising the 7 stages of document life cycle management - free download
7 Essential Elements of a document control system
1. A document control system supports workflows such as review and approval processes
The system has to have a document control procedure, ensuring there is only ever one master version of each document present in the system.
2. There is an audit trail and a full activity history available for every document.
This goes beyond mere event logs; it should be possible to easily view the activity history around a document when it was in a previous version.
3. Ease of use and installation is a major factor for success of a document control system
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.
4. 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.
5. Documents should be unique, categories should be dynamic and virtual
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"
6. The search engine should be able to index every text element in the repository
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
7. The document control system should be able to support collaboration with partially-trusted users
You need to give your contractors, freelancers, JV partners, access to your system to work with you freely, but without disclosure of other categories such as HR and Finance that are outside the ‘need to know’ boundary.
It’s essential that the search engine understands the information security controls that are in place and performs security trimming on any results before they are displayed to the search user.
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.