The decision to move from a paper-based quality system to one that is on-line creates challenges for the traditional laboratory. The tendency is to recreate the same structure of cabinet file drawers, file folders, documents, chapters, and pages online; as opposed to rethinking the quality system in terms of the relationship between the requirements and their implementation. An excellent example of this is the concept of the "Master List" required by clause 126.96.36.199 of ISO/IEC 17025, which states "A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system shall be established".
Many laboratories keep a list of documents controlled by the quality system in a spreadsheet. Whenever a controlled document is updated, the document itself is given a new revision, then the spreadsheet is updated to list the new revision level of the updated document. Older versions are marked as obsolete and removed from the laboratory or archived in a storage area. This works quite well but requires time and effort for administration and maintenance.
Another option implemented by some laboratories is to create a directory structure of documents and the directory listing itself is the Master List. This requires very little administration and maintenance beyond the documents themselves and functions well on a local area network. But, just like the paper-based system, this implementation can quickly lead to problems with clause 188.8.131.52(c), which states "invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use". Once a staff member downloads the document, it is very difficult to remove the obsolete versions from an individual's personal computer because once a document is downloaded, it is no longer a controlled document.
Summarizing, paper documents require administration and maintenance while soft-copy documents can become uncontrolled quickly. Another solution to maintaining the master list and controlling the documents is a web-based solution. There are several Content Management Systems (CMS) that allow non web programmers to create and manage websites without requiring a deep understanding of the underlying web technology. Some of the most popular are Drupal, Joomla, and WordPress; doing a web search of "Content Management System" will provide a much longer list.
Using a CMS solves the administration, maintenance, and document control issues that plague many labs. Their purpose is not to recreate a paper or soft-copy system, but to replace it with a flexible, robust system. Let's examine three of the most popular CRMs and how they can be applied to a laboratory quality system.
As one of the most popular, Wordpress is used on millions of websites and is very simple to install and use. There are thousands of extensions that can be added for increased functionality and can be scaled for small and large laboratories alike. For those that wish to create a single web page for each quality document, Wordpress can be a good choice.
For more control over the structure of the site and to create a hierarchy of documents, Joomla provides the functionality; albeit with a little bit more of a learning curve. Nested categories are easily created and can be used to structure the quality site similarly to a directory on a server. There are also thousands of extensions that can be installed for customization. For those that feel more comfortable with nested directories, Joomla can provide a quick start to recreating your server on-line while also taking advantage of the latest web technologies.
Although Drupal can be set up to do all the things that Wordpress and Joomla can do, it also allows the capability to add fields to any content type and to create views of all this data in many ways. This is the true power of Drupal over the others. However, this power comes at a price as the learning curve for Drupal is much steeper than that of Joomla or Wordpress but if creating an on-line database for your quality system is your intent, then Drupal is the choice.
There are many steps that can be taken to migrate a quality system to a web-based one. From creating a single html page for each quality document; to recreating an existing directory-tree structure; to truly embracing web technology and converting to a new way of thinking - there is no doubt that moving on-line is the way of the future. Regardless of which underlying technology is chosen, each can provide a list of documents with no additional effort beyond simply creating the necessary documents themselves. Being online, the documents are accessible and at the correct released versions at all times. A CMS also provides each document with a unique ID, versioning, and last update timestamp; satisfying the requirements of clause 4.3.3 as well.
Cognizance that Content Management Systems (CMS) already exist and don't have to be created begins the process of migrating online. The second step to a successful migration is the observation that the CMS likely manages documents differently than the lab has managed them in the past. Recognizing these observations provides the key to enhancing an existing quality system. The laboratory can focus on the content itself, instead of controlling the content. Content Management Systems are Document Control.