Learn why system validation matters, common pitfalls to avoid, and how expert project management helps maintain quality.
When technology plays a central role in running a business, quality and compliance can make or break a project, especially in industries where regulations are strict and oversight is constant. If your organization operates in regulated environments such as pharmaceuticals, healthcare, energy, or food and drug manufacturing, you’ve likely heard the term “validated system.” But what exactly does that mean, and why does it matter?
In simple terms, a validated system is a computer system that has been tested and documented to prove it does what it’s supposed to do, consistently, accurately, and in compliance with all applicable regulations. It’s about ensuring the system meets business requirements and regulatory standards every time it’s used.
For example, in the pharmaceutical industry, the Food and Drug Administration (FDA) requires validation for any system that affects product quality or patient safety. As noted by The FDA Group,
“Computer System Validation (CSV) is not merely an industry recommendation; it’s a regulatory necessity that bridges the gap between technology and regulatory compliance.”¹
Validation ensures that every component, from data entry to reporting, operates correctly and produces dependable, consistent results. That reliability is what auditors and inspectors look for, and the benefit of system validation can assist your organization with avoiding costly compliance issues in the future.
Regulatory Frameworks: Why They Matter
Validated systems are governed by a combination of regulatory and industry standards. One of the most well-known is 21 CFR Part 11, the FDA regulation outlining requirements for electronic records and electronic signatures. It ensures that digital systems maintain data integrity, authenticity, and traceability, all essential in industries where even small discrepancies can have major consequences.
As highlighted in a 2024 publication from the Journal of Drug Delivery and Therapeutics,
“A system that meets defined requirements can be assumed to be consistently performing in the way it was intended.”²
In other words, validation isn’t a one-time milestone, it’s an ongoing commitment to quality, documentation, and controlled change management.
Special Considerations for Validated Systems
Having worked on both validated and non-validated projects, I can say that managing a validated system project is different from a typical Information Technology (IT) project. There are additional steps, documentation, and approvals built into every phase of the Software Development Life Cycle (SDLC).
These often include developing and reviewing documentation such as a Validation Plan, User Requirements Specification, Functional and Design Specifications, Risk Assessment, Traceability Matrix, Test Plan, and Test Summary Report. Each document is reviewed, approved, and maintained to provide a complete, auditable trail of compliance.
Testing also takes on a higher level of rigor. Every test case must trace back to a specific requirement. Defects must be tracked, resolved, and retested to verify that corrections don’t introduce new issues. Once a system passes validation, it must remain in a controlled state through regular monitoring and change management procedures. Even a simple software update can trigger re-validation to ensure system integrity and compliance are maintained.
Managing a validated system project often requires close coordination among business users, Quality Assurance (QA), IT, and compliance teams, each with its own priorities and approval steps. Timelines can be tight, and documentation or testing delays can quickly impact rollout schedules. An experienced Project Manager or Test Lead who understands both the technical and regulatory sides of this process plays an important role, managing priorities and resources to keep the project moving forward, as well as identifying and addressing gaps or pitfalls that increase compliance risk.
Common Pitfalls to Avoid in Validated System Projects
Having worked as a project manager and test lead on several validated systems, some recurring challenges that can jeopardize compliance and schedules if not managed proactively are:
- Treating validation as a one-time project instead of a continuous lifecycle process
- Inadequate documentation or missing traceability between requirements and test cases
- Overlooking change control during updates or enhancements
- Failing to involve business process owners early in requirements definition
- Underestimating the time and resources required to achieve and maintain compliance
Addressing these risks early with clear communication, achievable objectives or goals, realistic project timelines, and proper test management can save significant time and cost later in the project.
Why It Matters
Validated systems may seem complex, but they serve a critical purpose: protecting consumers, ensuring data integrity, and maintaining compliance in highly regulated environments. In today’s climate of increasing oversight and digital transformation, organizations that invest in proper validation and compliance practices are better positioned for long-term success.
If your organization is planning a system upgrade or implementation that requires validation, Keller Schroeder’s Applications Solutions Group can help. Our consultants have experience managing validated projects across multiple industries, including pharmaceuticals, healthcare, energy, and utilities.
Contact Keller Schroeder today to discuss how we can help your next validated system project stay compliant, efficient, and on schedule.
Kim Wallace PMP, ACP
Project Manager/Test Lead, Applications Solutions Group
References
¹ The FDA Group – Computer System Validation (CSV) in the FDA-Regulated Industries
https://www.thefdagroup.com/blog/computer-system-validation
² Journal of Drug Delivery and Therapeutics – Computer System Validation in the Pharmaceutical Industry
https://pmc.ncbi.nlm.nih.gov/articles/PMC11416705/
