Product and System Verification

Realtime’s customers seek us out for testing services to fulfill their need for reliable results, proper documentation, and timeliness of delivery. Development projects most often run longer than expected, and too often become stalled in verification testing due to costly test rework, incorrect data collection, or improper documentation of objective evidence. Our seasoned specialists can significantly reduce the costs of developing Testing Plans, protocols, and results compliant with US FDA, ISO 13485, IEC 62304 (SW), & IEC 62366. Further, with Full Requirements Traceability assessments, we can help you demonstrate completeness of verification coverage.

The accepted practices in regulatory compliance are seeing a general shift towards use of risk management to appropriately scope the level of controls. In system verification, this has opened the door to innovations that can be used in certain situations as alternatives to traditional Requirements-Based testing. For example, Realtime can optimize the process by utilizing a risk-based approach to focus more heavily on critical areas (alarms, conditions that could make life-sustaining pumps stop, etc.). Realtime is an industry leader in deployment of such alternative test methods that can significantly reduce costs without an impact on risk.

For Example

Structured Exploratory Testing is a method employed at Realtime to efficiently assess the system from a user’s perspective without constraining the tester to specific actions or parameters. Traditional V&V is often structured to follow a single path. Exploratory testing allows the tester to go down one path and then re-visit the scenario if something is observed that may be an issue. Exploratory ad-hoc testing also enables a risk-based approach by focusing on critical areas. The tester is allowed to explore a scenario without prescriptive actions, enabling data capture. Bounds for pass/fail are defined, typically in terms of safe operations. Structured Exploratory Testing often reveals use (and misuse) cases, and Multi-Case Testing reveals timing or “overlap” conditions that may not have been considered through traditional test methods.

Multi-Event Testing

Multi-Event Testing is another method employed at Realtime that considers how events “piling up” can impact operations. These are often critical in life-sustaining applications, and they reveal unexpected and unaddressed scenarios in most applications. Alarms and events are usually sufficiently tested in isolation during verification testing, but the behavior is rarely defined when events pile up.

Realtime also provides Non-Product verification for business and development tools such as issue tracking software, manufacturing support software (e.g., MRP/ERP, labeling software and systems, etc) and test equipment software.   We can provide expert manufacturing process validation and equipment qualification to support your IQ/OQ/PQ compliance requirements, as well as validation for compliant use of Electronic Records and Electronic Signatures.