Imagine a world where you could write a 500-page book in a few hours. Where one can prepare the next season catalog of an online retail business with new products and prices with a few clicks. A world where you can quickly review and update a large clinical trial report and where you are always on time with the review and revision of all your SOPs. Well, this world exists. We just need to learn to live in it. The foundation, as it is often the case with revolutionary novelties, exists for a long time. It is called “xml” which stands for “Extensible Markup Language”. I will not bore you with technical explanations. I do not need to know how the ABS of my car works. All I want to know is that when I hit the breaks on a slippery road, the car will avoid going off the road to a certain extent. Same here. How xml works is the business of IT. What it can do for you and me is our business.
And it can do an awful lot. In a nutshell xml is the combination of text and data. Of “structured” and “unstructured” information to use a more technical term. In other words xml adds intelligence to plain text. Artificial intelligence, that is. A text can be very intelligent but only for human eyes. And human eyes can only read with a limited speed. When you are asked to read through a 600-page clinical study report and make sure that all changes from the last review have been implemented appropriately, you have a problem. So you ask for help from the study team. Now there are three people, including you, reviewing the same document. But they cannot just split it in three as the same information appears in several pars of the beast. So three people are now making more changes to this already complex document and, no surprise, there will be another round of checking to make sure that all changes match. Do you get the picture? Have you already experienced the pain?
Now imagine that you have a way to identify each part of the document as it is being written, a way to use pre-defined sentences or whole paragraphs and even be able to use language that has been previously approved by regulatory authorities so you take no risk of saying something wrong or inconsistent. What xml does, is just that. It allows a writer to “tag” text and give it a meaning. Meaning that computers will understand so that they will assist the writer by grouping related parts of the text, building libraries of terms, phrases, paragraphs, chapters and assigning actions to each of them. For instance, when a regulation changes, you could be alerted that some of your SOPs need to be updated, you would know exactly which ones, which part of the text needs changing and when you come to make the change, you only need to do it once and it will be repeated in all the places where it appears.
Now here comes the best part: all the tools for making what I described above happen exist and have been used extensively in the publishing business and other industries. Pharma has always been slow to adopt innovative technologies. There are many reasons to that. Our very long development cycles allow time for manual work to be done, our pharaonic budgets and revenues are too large to take the risk of having issues with new, poorly understood technologies and our highly specialized staff finds it hard to change old habits that have proven to be working in the past. Still we eventually do adopt them and when we do we are pretty good at it. For the exact same reasons. We want to make the most of what we use because the stakes are so high.
So what if we tried? Take SOPs as an example. Every pharma company has hundreds or even thousands of SOPs describing the precise way in which business in conducted. We are in the most highly regulated of all businesses and regular audits are performed by health authorities to make sure that our SOPs reflect the full set of rules and regulations worldwide. We are supposed to review and update our SOPs in a regular basis and of course we are supposed to make sure that they are consistent with one another as well as with our job descriptions and other sources of information. Can you put your hand over your heart and say that all this is true in your organization and will always be? If not then what is your risk? At best, you are doing a huge amount of work for little benefit as people tend to view SOPs not as a useful aid but as a necessary evil imposed upon them by regulatory bureaucrats. At worst you may get some nasty findings during audits and even end up with a consent decree forcing tight FDA control of all your work for years until they feel that you are back on track. Not to mention potential fines that can be very high by any standard.
Now let me show you how you can do complex work with reasonable resources while feeling confident about the output. How you can produce SOPs that are actually useful and will be used to increase the quality and decrease the cost of your work. SOPs that people will trust and use and be willing to refer to.
Take a tool that is an xml editor. It looks just like any word processing software, like Microsoft Word; only with a few additions. As you start typing, the software will ask you if you wish to use text from the library it has in store and will guide you in doing so. You do not have to use the suggested text but as you write, you realize that it is easier, faster and more reliable. Whole paragraphs from previous texts can be reused and as you move into the complexity of a clinical document for example, you reference text instead of re-writing it so that if a change is made later, it can be made only in one place and repeated everywhere inside the document. The more you work in the system the richer it becomes.
Back to our SOP example. Here we have a collection of documents, all with the same structure (Object of the SOP, scope of the SOP, roles and responsibilities and so on). The main challenge in this case is to avoid inconsistencies and to track inter-dependencies. This is very easily done using the SCA libraries. For example, the role of a person within the organization must be described in a consistent, although not identical, manner throughout the SOP system. A study physician has certain responsibilities some of which appear in one SOP and others in another. If the job description is stored in the library with the right granularity, the different responsibilities being listed separately and linked to the relevant regulations, it is very easy to refer to these when writing the SOPs. If later a regulation changes, the system will issue an alert that the responsibility needs to be updated, point the SOPs that contain it and allow changing these simply and quickly. Periodic SOP review is made easy as it can be done by theme rather than by document.
MAIA Consulting can assist your company in understanding in depth the possibilities of SCA, guide you through the choice of the right tools and help implementing a state-of-the-art authoring system based on the latest technologies.