By Philip Evans, Product Specialist and Thomas Hornbæk Svendsen, Principal Consultant, NNIT
A FirstDoc system is typically a backbone in managing critical documents such as electronic submissions to health authorities and the standard operating procedures which are a vital part of a Quality Management System (QMS). To perform optimally it has to stay sharp and calibrated. But over time all IT systems corrode and lose their initial resilience. This may jeopardize the organisation’s ability to be compliant with regulatory demands and to reach the business goals. So how do you keep your FirstDoc system in shape?
Typically, the problems lie in the details – a database congesting over time, patches that add poorly optimised application code, erroneous configuration settings or background jobs set up inappropriately. On a daily basis, the flaws and malfunctions are so small that you might not notice, but over time they accumulate and eventually constitute a problem which might jeopardize the business.
Whatever the cause is, users tend to get accus- tomed to the glitches and often it is only at the actually solving of the problem that they discover the system has been running less than optimal. As a result the business has been subdued to a solution and an investment not delivering the promised returns. The result is not only that users might have been experiencing more challenges using the FirstDoc system than otherwise, but also that time and money have been spent un- necessarily. These challenges could be experi- ences by all or a distinct set of users of a FirstDoc system, including infrequent users, power users or business administrators.
A FirstDoc system constitutes a complex stack of platform and application components:
Typically, the stack also includes:
Maintaining and optimising a FirstDoc system requires skills and experience which can only be established when working with the involved technologies for an extensive period. Also deliberate optimisation can only be realised by an organisation that employs specialists in each of the areas mentioned. And since most configura- tions deal with e.g. laboratory data, clinical trial applications or safety information, employees who possess a profound knowledge about life science processes are requested.
To keep your FirstDoc system in shape – both in terms of technical performance and configuration optimisation – you should check it regularly and not only at the occasion of an actual issue. Use a checklist to ensure that the same metrics are used in each check and make sure to document the findings. This approach allows you to identify trends that might turn into problems; you also get an overview of how the system works over time. With this empirical knowledge the basis for pinpointing areas in need of optimisation is provided, and areas eligible for configuration review are identified. Use it in the planning of your system’s maintenance and your prioritisation of activities – and keep your FirstDoc system in shape!
Article written: October 2016