6 Steps to Simplify Software Validation Information Security. Software Validation Protocol ( Validation Plan). Penny Goss has worked as a consultant and focused her business on verification and validation of technology controls and procedures to ensure compliance for businesses operating in regulated environments. Resources and Budget Management. Fda software validation consultant.
It regulates and approves medical devices and pharmaceuticals. Our expert FDA quality management systems consultants ensure your company meets FDA requirements with services ranging from audits to quality assurance. Medical device manufacturers have the responsibility of validating the software tools they use by demonstrating that the tools have an acceptably low risk of harm even given an incorrect output. The FDA does not certify or validate software development tools. ISO 13485 and FDA Quality System Requirements ( QSR) Agile and Scrum Methodologies.
Labeling, validation, Standard Operating Procedures ( SOPs), training, corrective and preventive actions, product adulteration, raw materials storage, risk management, or other quality.