.jpg)
Software validation is often viewed as a regulatory requirement reserved for quality systems and manufacturing processes. For pharmaceutical and medical device manufacturers, however, validation also plays a critical role in computerized maintenance management systems (CMMS). Validation helps manage equipment, maintenance records, calibration activities, and asset performance.
As regulated manufacturers continue digitizing maintenance operations, the role of software validation is becoming very important. Organizations operating under FDA oversight must demonstrate systems supporting regulated processes to perform as intended and generate accurate and traceable records. The expectation extends into the maintenance technologies that help ensure equipment remains fit for service.
"Software validation is a documented process required by the FDA under 21 CFR Part 11," said Jonathan Clark, CEO of MVP One. "Manufacturers regulated by the FDA must demonstrate that their CMMS consistently performs as intended and produces accurate, reliable, and traceable records."
According to Clark, software vendors can provide validation-ready platforms, supporting documentation, and testing materials. Responsibility for validation, however, belongs to the manufacturer.
"While CMMS software can be provided as 'validation ready' with supporting documentation and test scripts, the manufacturer is ultimately responsible for validating the software within its own environment and documenting that it meets its specific requirements," Clark said.
Validation delivers more than regulatory compliance. It also creates confidence that maintenance data can be trusted when users need to:
- Make critical operational decisions.
- Plan preventive maintenance strategies for a facility or asset.
- Evaluate asset performance for key insights.
- Prepare for an audit of an asset or a facility.
Why Software Validation Matters for Maintenance Operations
Maintenance records may not document product quality, but they do provide evidence that critical manufacturing assets are operating correctly.
"The FDA generally does not care about the actual maintenance records," Clark said. "What the regulators care about is whether equipment used to make regulated products is operating correctly and consistently."
For example, consider a sterilizer that misses calibration requirements, an HVAC system operating outside specifications, or a production asset with undocumented maintenance history can introduce risk into regulated operations. Missing these details, especially in heavily regulated industries like pharma and medical devices, can impact consumers and potentially be dangerous if the production line has been contaminated or damaged. Transparent maintenance records stored within a CMMS can help demonstrate activities are being performed according to established procedures.
Validation also helps ensure that those records are accurate. For maintenance managers, reliability supports better decision-making. Work order data can be used with greater confidence to identify repeat failures and optimize maintenance strategies.
A validated CMMS reduces operational and compliance risks while supporting stronger governance of maintenance programs. During inspections and audits, organizations can demonstrate maintenance data that has been collected and managed through documented processes.
Clark said documentation is critical when asked how validation differs from standard implementation. "A maintenance manager may know that work orders are being completed correctly in the CMMS and that everything seems to be working as expected. Validation takes it a step further by documenting and testing those processes to prove they work consistently."
That documentation becomes critical when organizations must provide evidence that maintenance processes are repeatable and compliant.
What Organizations Should Look for in a Validation-Ready CMMS
As manufacturers evaluate CMMS platforms, they also should assess the system's ability to support data integrity and user accountability.
"Software validation is only one component of FDA 21 CFR Part 11 compliance," Clark said. "When evaluating a CMMS, manufacturers need to confirm not only that the software performs as intended, but also that it can securely control user access, track changes to records through audit trails, maintain accurate and traceable data, and support electronic signatures where required."
Key capabilities include:
- Audit trails.
- User access controls.
- Electronic signatures.
- Record retention functionality.
- Validation support.
Clark said these features help organizations demonstrate maintenance records are suitable for regulatory compliance by creating a verifiable data thread.
When asked how MVP One addresses these requirements, Clark said, "MVP One helps pharmaceutical and medical device manufacturers simplify CMMS validation by providing a validation ready platform with audit trails, security controls, user access management, electronic signatures, and electronic record management capabilities.”
As digital transformation accelerates, maintenance teams also are evaluating the role AI can play in improving processes and productivity.
Clark believes AI can improve productivity by helping organizations prioritize work, identify equipment risks, and analyze maintenance data. However, he noted that regulatory expectations surrounding traceability and data integrity will remain essential.
"AI has the potential to make maintenance teams more productive by helping prioritize work, identify equipment risks, analyze historical data, and improve decision making," he said. "As AI becomes more common in regulated environments, manufacturers will need to understand how AI generated recommendations are created and ensure that the underlying records remain accurate, traceable, and auditable."
The business case for software validation is clear. Validation creates confidence in maintenance data and helps ensure critical assets continue operating as intended. In regulated industries where equipment performance directly affects product quality and patient safety, a validated CMMS serves as a compliance tool and strategic operational asset.
