Verification and Validation
Software Product
Verification and Validation
ALOPA offers a wide range of healthcare testing services and medical
software verification and validation services.
Verification and Validation at Alopa
In the healthcare domain, verification and validation is required as a part of designing and developing a medical device, implementing a manufacturing or production process, or ensuring appropriateness of design.
Ensure quality and optimize performance of Healthcare & Lifesciences based apps
Verification covers inspection, measurement analysis or testing which proves correct output relative to design input. Validation proves that the final design output will perform as intended. It is an act of demonstrating that any procedure and process will consistently lead to expected results.
Some of the salient aspects of Alopa’s verification and validation process are:
Best practices in every phase of development
Insight into health IT topics by SMEs
Product and process validation
Software validation
Compliance with Code of Federal Regulations(CFR)
Quality system regulation is harmonized with ISO standards
Risk management
HIPPA
Ensure Software developed complies with FDA regulations and protects the safety of operators and patients
Verification and validation activity is typically driven by regulatory environment and international standards. Regulatory agencies conduct inspections to ensure manufacturing companies comply with validation activities.
Verification and validation are independent procedures that are used together for checking if a product or process is in place and meets requirements and specifications intended. These are critical for a good Quality Management System (QMS).
The US Food and Drug Administration’s Quality System Regulation CFR often uses these terms of Verification and Validation.
