Often, when life sciences companies are working to define their controlled document management process, they spend a lot of time considering the regulations and ensuring that their approval process and electronic signatures are compliant. However, the regulations don’t require the process to be easy or efficient, and prioritising compliance over practicality often results in cumbersome and complicated procedures.
Of course it’s crucial to make sure your process is compliant, but we would suggest focusing on the document lifecycle too (see figure 1 below), to ensure it’s also efficient and user-friendly.
The authoring cycle
The first stage in any controlled document’s lifecycle is a cycle in itself – the authoring cycle. It’s here where each document is written, reviewed, amended, approved and eventually published.
At any point in the future a document may revert back to the authoring cycle, when a new version is prepared.
Document consumption
Once a document has been published it enters the consumption phase of its lifecycle. In the case of controlled documents, this may mean being used as:
- training collateral
- a brochure
- a manual or guidelines
- reference material for audits.
Getting the balance right
When only the regulatory requirements are taken into consideration, the consumption phase is often neglected. However it’s important to bear these facts in mind:
- It is in the consumption phase that the document actually matters. If it’s not consumed, the document will have no impact at all. This means it’s important to make sure each controlled document will be readily available at every relevant point of use.
- In most cases, many more people will be involved in consuming a document than in authoring and approving it.
- The people who use a document may have a wide range of different skills and needs. Some documents may be accessed by patients looking for information about specific treatments as well as their doctors and your company’s own employees. The needs and abilities of each potential audience need to be taken into consideration.
These key facts trigger a whole set of requirements and priorities that are specific to the consumption phase.
The following table provides a high-level checklist of requirements for your controlled document platform, taking into consideration these two fundamentally different stages of the document lifecycle.
This could be a good starting point for mapping your document control platform requirements. Note that the importance of each need at each phase will vary, even for different documents within the same organisation, so you may need to complete the checklist a few times to cover different categories of document.
| Need | Authoting cycle | Document consumption phase |
|---|---|---|
| Document write-up and authoring tools, such as a rich editor and the ability to import or attach content from different sources and formats | Important. | Irrelevant.
No document editing is done at the consumption phase. |
| Providing feedback on documents | Important.
Reviewers must be able to provide detailed commentary and feedback. |
Important.
Document consumers should be able to ask questions, point out errors and suggest improvements to documents. Their feedback will generally be less comprehensive than that of the assigned reviewers at the authoring phase, however it is still valuable, all the more so for being unsolicited. So the easier you make it for people to leave feedback, the better. |
| Officially approving and signing off documents | Important.
Signature registration is vital for compliance. |
Critical.
Some users may only need to access certain documents occasionally, so you should make it as easy as possible for them to find them when they do. |
| Ease of locating and retrieving documents | Important.
However most authors and reviewers will generally be familiar with the systems in place so will usually be able to access the documents fairly easily. |
Critical.
Some users may only need to access certain documents occasionally, so you should make it as easy as possible for them to find them when they do. |
| Ability to access documents in various formats and mediums (eg paper, online or on an internal network) | Not important. | Can be important.
In many cases it will be a requirement to make certain documents accessible to patients. |
| Document identification, version control and audit trails | Important. | Important. |
| Access control (through user credentials) | Important. | Important. |
| Sharing with the public | Not important. | Important for those documents which are meant to be shared with the wider public. |
| Configuration control (ensuring that only the current version is in use) | Important. Your team needs access to the most recent version as well as to previous versions and drafts. |
Critical.
At any given time only the most recent approved document version should be accessible. |
When companies ask for our help setting up a new controlled document management system, we first use this table to explore their requirements and priorities. We also consider other crucial needs, such as:
- document retention and archiving
- business continuity and resilience.
We then configure Confluence accordingly and supplement it with a tailored mix of commercially-available plugins and extensions we’ve developed ourselves. The end result is a system which is not only compliant with regulations, but also with the needs of the people who will be developing and accessing the documents.
If you’d like to find out how more about how we could develop a document management system to suit the needs of your team and the people who use the documents you create, please get in touch.