Validating computer systems
This could have been demonstrated in a number of ways such as: So where are we now?
There will have been a process for deciding what does and doesn’t get included in each Sprint and the process and the decisions made from following it need to be documented formally.
It is recommended that decisions are not contained in informal meeting minutes from which it’s not clear what has and hasn’t been included and why, but in a formalised signed off document.
It could be that no changes were needed to the black box tests scripts but there was no evidence of any review having taken place to confirm this, so again that bug fix has been released in a potentially unvalidated state.
So what does all this mean if you are a potential user of software that was validated outside of your organisation?
The only documentation available stated that some things had been added and the subsequent black box testing was performed using scripts that were approved prior to the developer having made the changes.
As a result the approved test scripts may not have captured any impact the developer’s changes may have had that would have needed additional testing.
CSV is an important part of the development and use of computer systems within clinical trials and it applies not just to specialist e System vendors, but also Clinical Trials Units (CTUs) or Clinical Research Organisations (CROs) offering randomisation and Interactive Response Technology services, specialist analytical software developers and sponsor organisations developing their own software solutions.
Whether you are using a product that has been validated by a vendor, ensuring a vendor’s product is validated and fit for use, validating your own product or validating a trial specific configuration/build, this post is intended to provide some guidance on the type of validation activities you should be considering.
The critical finding was given for a number of reasons, firstly because of the impact a lack of validation can have on the both the trial data and its subjects.