Ways to Improve Your Software Verification Skills

 

Software if present in medical device has very important role to play as it controls, executes actions and some time reads data and acts accordingly. This can be called brain of medical device.

The importance of getting the software system verified and validated is mandatory as per regulatory requirement. Failure to fulfil verification and validation standards, ends up in a substandard product, the surest direction for disaster that can be of any magnitude. software system verification and validation failure is that the third most frequently cited violation for medical devices by the agency.

Software system in medical devices is being perceives as fancy feature by many, however this makes complicated  interaction of several connecting devices more simpler and therefore  user friendly.

Thus, importance of software is so important and apart from its complicity its user friendliness is prime motto of designer. Hence development of software and skill going inside is very important.

1. ·         Designer also must contribute for Developing and creating logic which can be verified and validated.
2. ·         Understanding,that it will undergo strict scrutiny of US FDA or other regulatory body’s
3. ·         Beyond just in-product software V&V – understanding FDA’s expectation for your testing software, and related documentation.
4. ·         When and how to use DQ, IQ, OQ, PQ or their equivalents
5. ·         How GAMP 4/5 requirements fit into your V&V planning and execution
6. ·         Detailing the FDA’s 11 key V&V documentation elements and the ones that are applicable to software validation.