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Software Validation

Software Validation Services

Enterprise software is imperative for effectively competing in today’s global economy. In highly-regulated manufacturing environments like medical devices, deploying new software comes with its own set of challenges. Companies have to comply with FDA and international regulatory requirements for security, data integrity, electronic signatures, and functionality through software validation.

Software validation may seem like nothing more than a “cost of doing business,” but the reality is validation processes are designed to ensure your new solution is set up to improve rather than inhibit quality management. Getting software validation right can potentially save billions of dollars for companies that must comply with FDA regulatory mandates.

IQS Software Validation Services allow leading global enterprises to satisfy domestic and international regulatory demands in a cost-effective way.

Challenges of Software Validation

The complexities of domestic and international regulatory requirements cannot be underestimated. What’s more, governments and other parties involved are constantly amending them. Enterprise software can transform your organization, but focusing on the wrong risk factors at the wrong time during the nascent stages of software implementation can be a costly mistake in the long run.

Despite a sharp increase in FDA 483s and Warning Letters in the past several years, software validation initiatives haven’t been given the proper respect and prioritization within many organizations. Following best practices is a good start to reducing the likelihood of a violation, but it’s far from the scientific, risk-based approach professional services organizations offer during an implementation.

Risk management is key during enterprise software validation. It helps manufacturers deploy their solution in a way that considerably reduces the potential for lost resources and time, as well as the dreaded system-wide failure. However, that’s difficult to execute without expertise. Not knowing any better, many organizations focus on superficial issues rather than ones that matter the most.


The IQS Approach to Software Validation

We believe effective software validation is key for you to get the most out of IQS enterprise solutions throughout the lifecycle of our partnership.

By differentiating the risks of potential problems in business processes or software usage, our priority is identifying and resolving the most critical risk factors first. We go beyond superficial analyses to help identify areas of concern well before problems propagate. Our team does this by deploying a proven, structured, and risk-based software validation approach.

Because of the dynamic regulatory environment or operational changes which may occur, the need for risk mitigation in quality management systems may surface at any point of software usage. Our best-in-class methodology aims to identify and resolve issues during the implementation process, in addition to as they occur over time, especially those that reside below surface-level analyses.


Software Validation Is a Process

The IQS Software Validation Team takes an incremental approach to the software validation process. These steps include:

  • Reviewing validation and system procedures
  • Creating a validation plan
  • Assessing risk
  • Compiling the requisite documentation
  • Executing the validation protocols
  • Recording and reporting the results of the validation

There’s no one-size-fits-all approach to software validation. The level of IQS’s role can be adjusted for project-specific requirements, or in accordance with a company’s own internal software validation procedures.

The importance of software validation should not be overlooked. Regulatory bodies are unforgiving, and the consequences of not meeting their requirements can be significant. IQS works side-by-side with companies to develop, plan, and execute successful software validation projects. We deliver a tailored, industry-forward validation solution to meet manufacturers’ specific goals.


Here is a sampling of IQS software validation customers.

software validation customer_burts bees_IQS
software validation customer_clorox_IQS


Enterprise resource planning (ERP) software plays a key role in helping companies to satisfy regulatory mandates such as cGMP, GAMP, FDA 21 CFR part 11 and FDA 21 CFR part 820. From an enterprise-wide framework, an ERP system is key to managing FDA-mandated documentation and integrating all external and internal information in a single system.


Enterprises must be proactive when deploying risk management strategies. Risk management and its process is a mission-critical component of software validation best practices, which encompass the entire product lifecycle from conception to post-production monitoring. Establishing a documented risk management process is specifically suggested by regulations.


Supporting key features of a modern laboratory’s operations, a Laboratory and Information Management System (LIMS) is an essential component of sound quality management in FDA regulated industries. manufacturers must validate the software deployed in various medical devices to ensure the safety of products before they reach the open market.


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