As the tester starts exploring the system, new test design ideas are thought of on the fly and executed against the software under test.On an exploratory testing session, the tester executes a chain of actions against the system, each action depends on the result of the previous action, hence the outcome of the result of the actions could influence what the tester does next, therefore the test sessions are not identical.As well as the e-QMS’s potential impact on the product, one of the key changes to ISO13485 is the clarification that regulatory requirements are now expected to be considered as well as that required by the guidance.
ISO13485 has always implicitly implied that software applications supporting the design, development and quality management system (QMS) processes require to be validated.
The standard was updated to stipulate that software systems supporting the QMS now must be validated. Why do I need to validate my electronic quality management system (e QMS)?
During that time she has built a deep understanding of the industry demands and requirements, particularly in the topics of validation and data integrity. When facing calibration there are many factors to consider to ensure accurate, reliable and cost-effective servicing.
Aligning her knowledge of the industry and Ideagen’s products and services to the business needs of the industry is a key objective of her role. After reviewing your options, outsourcing gage calibration may be the logical approach.
The ability to perform accurate quality inspections – quickly, easily and consistently – is paramount to your reputation and profitability.