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Software validation is the process of ensuring that software products meet their intended requirements and specifications. It involves planning, design, testing, and documentation to identify and correct defects or errors. By following a systematic approach to software validation, developers can ensure that their products are reliable, efficient, and meet industry standards and regulations.
Medical Equipment Validation is a critical process that ensures the safety, efficacy, and accuracy of medical equipment. It involves testing and verifying the equipment's performance against established standards and specifications. Validation is required for all newly acquired medical equipment and existing equipment that has undergone repairs or modifications. The benefits include compliance with regulatory agencies, improved patient outcomes, and greater confidence in the care received.
Process validation is a systematic procedure that ensures a manufacturing process consistently produces quality products. It involves three stages: process design, process qualification, and continued process verification. The goal is to reduce the risk of product defects and recalls, improve quality, and minimize costs. A robust process validation methodology helps manufacturers meet regulatory requirements and customer expectations. Add a description about this item
Medical device manufacturers adhere to and comply with international standards such as ISO 14971 and FDA requirements while following a systematic risk management process. The risk management process entails identifying and analyzing potential hazards associated with the device, evaluating the risks associated with each hazard, and implementing measures to mitigate the risks.
Defect Management is a systematic process of identifying and fixing bugs. There are various ways you can manage defects. A defect management cycle contains the following stages:
Our team will teach you an effective way to manage a defect and its life cycle.
No good data, no room for improvement; that's why the industry needs to protect its data; we need to minimize the risk of data loss.
The following points will improve data integrity:
Change Control is one of the first documents that should initiate the process for the software lifecycle.
There are many standards and guidance for a pharmaceutical company. We will teach you according to industry needs, but not limited to below standards: