Question

the importance of validating our labs, software and hardware.

Answer 1

Answer:-

System Hardware validation is essential when the hardware is to be used in a process or task that can have any effect on the quality, safety, efficacy of the product or product mandated data.

Complex systems that are used in cost-critical and life-critical applications motivates the need for a systematic approach to verifying functionality. Hardware verification complexity has increased to the point that it can dominate the cost of design. In order to manage the complexity of the problem, we have to investigate validation techniques, in which functionality is verified by simulating (or emulating) a system description with a given test input sequence.

However, formal techniques suffer from high complexity, so the verification of large designs using formal techniques alone is often intractable. The complexity of validation can be made tractable by using a test sequence of reasonable length, and the degree of certainty provided can become arbitrarily close to 100%.

A practical difficulty in the validation of large hardware systems is choosing the proper design abstraction level which provides a trade-off between simulation complexity and error modelling accuracy. In practice, validation is performed at all levels of abstraction from behavioral down to layout. Behavioral hardware description languages, such as VHDL and Verilog, have only been fully accepted by industry for less than a decade, and research in behavioral validation is still developing.

Computer system validation helps to ensure that both new and existing computer systems consistently fulfill their intended purpose and produce accurate and reliable results that enable regulatory compliance, fulfillment of user requirements, and the ability to discern invalid and/or altered records. CSV utilizes both static and dynamic testing activities that are conducted throughout the software development lifecycle (SDLC) – from system implementation to retirement.

The FDA defines software validation as “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.” Computer systems need to be examined to confirm that the system will work in all situations. Additionally, all validation activities and test results need to be documented.

All CSV activities should be documented with the following:

• System inventory and assessment – determination of which systems need to be validated
• User requirement specifications – clearly defines what the system should do, along with operational (regulatory) constraints
• Functional requirement specifications – clearly defines how the system will look and function for the user to be able to achieve the user requirements.
• Validation Plan (VP) – defines objectives of the validation and approach for maintaining validation status
• Validation Risk assessments – analysis of failure scenarios to determine scope of validation efforts
• Validation Traceability Matrix – cross reference between user and functional requirements and verification that everything has been tested
• Network and Infrastructure Qualification – documentation showing that the network and infrastructure hardware/software supporting the application system being validated has been installed correctly and is functioning as intended
• Installation Qualification (IQ) Scripts and Results – test cases for checking that system has been installed correctly in user environment
• Operational Qualification (OQ) Scripts and Results – test cases for checking that system does what it is intended to do in user environment
• Performance Qualification (PQ) Scripts and Results – test cases for checking that System does what it is intended to do with trained people following SOPs in the production environment even under worst case conditions
• Validation Report – a review of all activities and documents against the Validation Plan
• System Release Documentation – documents that validation activities are complete and the system is available for intended use.