Document Management

For my first ‘real’ post I thought I should approach the subject of document management, and more specifically, document management systems (DMS). The importance of effective document management can’t be overstated in founding and maintaining an efficient, well ordered and audit ready Regulatory department. DMSs such as SCORE or Documentum’ FirstDoc are powerful tools which primarily act as a repository for your company’s documents. But they can do so much more than this. They are designed to: interact with publishing software, enable document workflows, archive documents, provide audit trails…there are too many features to list here!  

So, what do I mean by ‘effective document management’? Well, from my experience working in a number of systems and seeing first hand the nightmares that substandard document management can cause, I would simmer it down to the following question:

                “Although I can find and use this document, could my
                                    successor or theirs…!?”

 At the lowest, most practical level, this really is the most important question to ask – everything else for now can wait. The ability to find and use documents efficiently underpins everything good document management practice is all about. Hours can be wasted searching for important documents in a DMS which, inevitably, were authored by someone no longer at the company and need to be located for an important Variation or possibly even worse, for audit purposes. I know, because I’ve been there.

I’ll address some of the usual pitfalls below…

• Are your colleagues even using the system?

If one thing’s for sure it’s this – if your documents aren’t even in your DMS, nobody will be able to find them within it. That’s a fairly obvious statement of fact. I’ve had people send me documents by email, or even on a portable hard drive in order to avoid having to upload important submission documents into a DMS [I’ll come to this again later]. This means that should anyone else need to cover for me, or replace me and my colleague on a permanent basis, it would be as if the document had never existed. Vanished for all eternity. A DMS can be an expensive tool, it’s probably a good idea to use it.

• How are you naming your documents?

The most important piece of metadata associated with a document is, of course, its name. It’s the most obvious way of differentiating between documents in any folder, but more than that, it should be used to tell you what the document actually is. Document names such as “Document 1” or “Appendix 2” give you very little idea about what you’re going to see when you open it up. A good naming convention could contain some or all of the following:

CTD Number or name: 1.2 Application Form

Product and/or INN name: Wonderdrug (amazingsubstance)
The date it was drafted: 03 June 2011

Simple things like naming conventions can dramatically reduce the time spent searching for documents.

• How are you organising your documents?

One of the most important features of any DMS is its folder structure. A typical DMS will file all of your products into so called ‘Cabinets’ but then the way in which folders are arranged below this level is mostly up to you. It’s a good idea to keep documents from different lines completely separate. Clinical, Nonclinical, CMC…etc. should all have their own areas of the DMS in which to operate. Within these areas it would be a good idea to use a folder hierarchy to keep documents separate. Break the structure down into a low level; for example a folder for each CTD section. Finding a file in a folder containing 5 documents is much easier than finding a file in a folder containing 500. It’s much easier to navigate a well designed folder structure than search through pages and pages of files.

• Are your staff well trained with access to well drafted user guides?

Keeping your staff trained, with access to well drafted training guides is absolutely critical to maintaining high standards of document management. A brand new DMS can be a daunting prospect for document authors, so make sure that they have the confidence to use it, and the ability to find help when they need it. If they don’t have this, they’ll either make mistakes or avoid using the system altogether (and who could blame them?). Remember, the DMS is only as useful as you make it.

 

These are but a few of the issues to consider when thinking about and implementing a DMS; I’ve only addressed a small number. If you need any advice on finding the right DMS for your company, or need help establishing processes please do get in touch with us via our website www.apexregulatory.co.uk and we’d be glad to help you take those all important next steps.

First Post!

Welcome to our blog! Apex Regulatory specialise in all things to do with Regulatory Operations. We'll use this blog from time to time to share updates and helpful snippets which will hopefully shed some light on our world. eCTD creation, document formatting and best practice for document storage - a few of the topics you can expect us to explain and (hopefully) help you with.

We do offer a professional publishing and consultancy service, so if this is something you require please have a look at our website (http://www.apexregulatory.co.uk/) and feel free to get in touch!

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