Software Validation: Harder Than it Has to Be

Selecting and validating a software program for GxP use can be a daunting process, but the basic steps seem uncomplicated, and indeed, the basic concept is straightforward, comprised primarily of the following steps:

  • Document requirements that meet the user requirements and satisfy regulatory expectations.
  • Find software that will meet the requirements.
  • Install and configure the software.
  • Validate the hardware and software system.
  • Use the software as designed.

How long could that take?
It is straightforward if you do it in a vacuum. If you do it in a company, it is more like this:

  • Get a group together that represents the stakeholders (QA, IT, Calibration) to start with, all of whom are already busy.
  • Have multiple meetings to determine requirements on which everyone can agree.
  • Research software that can meet these requirements, and if none can be found, design your own.
  • Discover that the software available for qualification is expensive and may involve other departments.
  • Increase your stakeholders to include more busy people that may be affected by the new software (maintenance, doc control, etc) and to include folks required to approve the higher price tag. Reassess the requirements based on the additional participation.
  • Work with this team to select the software and (now) hardware, configure it appropriately.
  • Develop the SOPs and protocols and allocate resources to backup, maintain, and implement change control over the software
  • Test and validate the software, (or hire a consultant to do so), and sign off the validation report.
  • Use it…but don’t break it, because if you do, you have to get an upgrade…and well, that will require some qualification, and maybe new hardware to run the new software…

It turns out that this is a familiar experience to many folks in the pharmaceutical and other industries regulated by the FDA. Over the years, based on experience as purchasers and consultants supporting software validation, we have formed a team and developed a method and software that dramatically reduces the pain in this experience by reducing up-front costs and time investments for our customers when compared to conventional methods. This also enables earlier compliance, and the empowerment of managers to get their work done within their budgets and timelines and with the personnel already available.

Perhaps this can allow companies to spend more of those investor dollars on getting drugs and/or therapies to market more quickly. This, in turn, may benefit patients by reducing the costs they incur awaiting new and more effective treatments.