One of the key enablers to delivering the highest quality for an organization is a quality management software (QMS). A QMS provides immense benefits, and an organization may not realize them directly; however, the organization can be significantly impacted in the absence of one, primarily in terms of efficiency, quality checks, planning, and other critical parameters that benefit immensely from a dedicated QMS.
Currently, the QMS market is growing promisingly at a healthy rate of almost 10 percent, and is looking to scale a valuation of $10.4 billion. Several factors can be attributed to this growth, one being the ever-increasing need for data collection and insight generation. Compliance also remains an area of concern with most organizations. With increasing globalization, organizations are looking to enter markets with larger opportunities. However, new markets and existing ones are formulating regulations to monitor situations and establish guidelines, creating a need for organizations to be compliant with regulations — for example, the GDPR in Europe in 2018, the ICH E6 (R2) in 2016, the ISO 9001:2015, and others.
Another key factor is the adoption of the software in businesses of all sizes, particularly small and midsize businesses (SMBs). Owing to the proliferation of cloud deployments, SaaS software, etc., SMBs are also realizing the benefits of investing in a dedicated QMS. Speaking of digital transformation activities such as cloud deployments, other transformative technologies such as industrial IoT and predictive analytics are also generating the need for a QMS.
Supplier Landscape and Software Overview
The supplier landscape for QMS at this point is stacked with several new players entering the market, making the existing landscape competitive. Certain suppliers tend to focus on certain industries, for example, DDi, QUMAS/BIOVIA, AssurX, and Pilgrim Quality primarily focus on healthcare; Arena Solutions and Plex focus on the automotive/manufacturing industry, and so on, which make them stand out. There are suppliers — such as MasterControl, Ideagen, Sparta Systems and MetricStream — that are also industry agnostic, and have expertise in multiple industries. Certain suppliers are rapidly evolving to include better technology such as proactive insights and business rule engines, so that risks can be heavily mitigated and the organization can have better foresight. Suppliers such as Ideagen, DDi, Pilgrim and MasterControl possess or are investing to add these functionalities in order to help buyers assess risks proactively.
Some of the important features that a standard QMS comes bundled with is communications management, which allows business teams to collaborate and plan meetings with agility. Nonconformance/CAPA management helps to perform root cause analysis to identify and analyze errors (if any) at each stage. Risk and compliance management is another important module for analyzing risk and preventing compliance issues. The supplier performance monitoring module helps the buyer to assess their supplier’s performance in terms of output quality, compliance, KPI monitoring and so on. Apart from the key modules of a QMS, additional functionality such as advanced dashboarding and reporting, collaboration and document management further assist the case for having a dedicated QMS in place, which will not only help the organization realize value in terms of process efficiency, higher quality standards and output, and better risk monitoring and avoidance, but also cost savings in terms of less manual errors and faster time to market.