When designing a controlled document management system, it’s important to take the requirements of everyone who may need to access the documents into account. That’s why mapping users’ needs through each stage of the controlled document lifecycle is a key element in each of our quality management projects.
The list below shows how a document management solution based on Confluence meets the main requirements of any life sciences quality management system (expand each title to read the details):
Ease of document preparation, eg access to a rich text editor and ability to import or attach content from different sources and formats
Confluence has a great, easy-to-use editor built in, which takes advantage of some very powerful macros. For example, it’s easy to embed parts of one document within another, so there’s no need to copy and paste the same definitions into each of your standard operating procedure (SOP) documents. What’s more, a change to the definition in the original location will be immediately reflected in all the documents that include it.
For those who prefer to edit their documents in Microsoft Word, it’s easy to attach Word documents to Confluence pages, as well as media like video.
I cannot avoid mentioning here the powerful templates and blueprints paradigm in Confluence. These predefined structures help to standardise layout, section structure and approval, so everyone can create content like a pro.
Providing feedback on documents
Multiple methods are available in Confluence for providing feedback on documents:
• Inline comments, with the support of long discussion chains, are available both for Confluence content and attached documents.
- More generic comments can be added in the comments area available at the end of each page.
Confluence encourages the sort of collaborative interaction that can yield a goldmine of ideas on how documents could be improved.
Document approval and sign-off
An FDA CFR 21 compliant workflow can be implemented in Confluence using the Comala Workflows plugin.
Ease of locating, retrieving and navigating documents
Three particular aspects of the Confluence platform make it easier to find documents and access the information you need:
- Configurable dashboards put the most relevant pages at users’ fingertips. This is a great way to declutter and cut through the noise.
- The search mechanism, based on leading search engine Apache Lucene, offers fast, accurate search and retrieval.
- It facilitates logical document storage and hierarchy.
For example, we recently set up a dashboard for a client that shows each author all their documents which are currently going through the approval process, including the most recent information about pending and rejected reviews. Each user can also set up a personalised table of contents, which always displays links to the pages most relevant to them.
Ability to access documents in various formats and mediums, eg online or hard copy
Documents in a Confluence instance, whatever their format, are accessible through any web browser. Access can be made available on the company intranet or to a wider audience. It’s also easy to export Confluence content in PDF or Word format.
One of the areas where we help companies is embedding their standard document layout and styles into Confluence. This means all documents will conform to the brand style and exported content will be ready to share with third parties.
Document identification, version control and audit trails
Confluence can be extended to comply with controlled document regulations and best practices.
At RadBee we’ve developed our own macros that create automatic audit trails and maintain and display document identification information and electronic approvals.
Confluence has a powerful authorisation mechanism. Generally, users will not even be aware of the content they don’t have access to.
Depending on the sensitivity of your data, additional layers of security can be built into the infrastructure that hosts the Confluence instance, either on-premise or in the cloud.
Configuration control (ensuring that only the current version is in use)
Confluence retains all the historical versions of each document, including intermediate drafts as well as official versions. However, the way we set systems up, only the current version is displayed through the default interface.
Best practice is to move pages in the process of being written or updated into a different space from the one where the official versions appear. This improves efficiency and eliminates confusion by preventing a clutter of not-yet-approved versions getting in the way of the official ones.
As you can see, although Confluence was originally designed to aid software development, with the right configuration and customisation it’s perfect for creating, editing and managing controlled documents. It provides valuable flexibility while driving consistency and promoting continuous improvement.
If you would like help implementing a Confluence-based document management system at your company, please get in touch.The information provided relate to using a customised and configured Confluence Server installation, relying on the current version at the time of publishing (version 5.9.4).