The role of Quality Management System in Software Validation and Development

Industry: Software        Added By: 247Compliance        Posted On: Aug. 7, 2019


Quality Management System (QMS) consists of a set of process, procedures, and responsibilities, which an organization needs to follow, to meet the customer’s requirement and enhance its effectiveness, while they are developing any software application. As tedious and exhausting the software development process is, its validation and maintenance is another lengthy and time-consuming process as it is. But how much does it impact the software validation process? How far effective can be the implementation of Quality Management Systems over the software validation process?

Most organizations are hesitant in investing time and cost over a prolonged QMS process and following every procedure that seems to be never-ending. With various versions of QMS implemented, ISO 9001:2015 is the most widely used and applicable Quality Management System platform. Of all the major activities performed by the Quality Management System, lowering cost, reducing waste, enhancing the quality of various systems, engaging quality training facilities, enhancing broader scope to set directions for organizations to achieve long term goals, are some of the major operations carried by the QMS. Indeed on the broader scope, the QMS does affect every aspect of an organization's working paradigm, from regulating the organization's quality to maintaining the standards set by its procedures and instructions.

Coming to the software quality consideration, QMS documentation implemented is ISO 13485:2016, replacing the older version of ISO 13485:2003. The major implementation that is outlined by the ISO 13485:2016, depicts that the software must be validated before its initial use or its application. There are various ways in which Software Validation can consume less time and cost than usual while also enhancing the quality procedures within it entirely. Conducting an internal vendor audit is one of the important ways to effectively implement the QMS process, wherein the vendor feels confident about the quality of development and testing process about the software. This in turn, also enhances the customer-vendor relationship at a broader level. Moreover, imparting strong confidence in the vendor can help the organizations have a grip on the test efforts of the vendor than in reproducing it.

Another major effective way of implementing a stronger QMS is to conduct a risk-based assessment during software development and validation process. Having a track on the regular modification and implementing standardized milestone checks on the visit and re-visits to the entire software process can ease the risk factor of the software development process. Conducting a risk-based approach while software validation, is highly useful when the software development process is visited and revisited time and again for important timely modification, probably as per customer's request to enhance their software.

Adapting the ideology of Critical Business Process is always a good idea. Not everything, in your development process, needs to be critically validated. Validation becomes a lengthy process when every little aspect of the software development process is validated again and again, even if there is any requirement to do so as such. Validating only the essential functions and activities, which affects the development of the product and services in terms of safety, quality, and consistency, must be considered as a priority than any other factors. Implementing CBPs, will not only help you cut short the validating process, but it will also help you enhance the growth and stability of your services and products, quite consistently in the pool of market competition.

With recent times, the implementation of the QMS has become one of the important paradigms to ramify all the quality and security issues in the software development process. Having a software development process that involves a stringent Quality Management System has always proved to enhance the software validation process, which in turn, enhances the quality and functionality of the software application with less technical issues.