Validating software fda
As part of meeting regulatory requirements, companies must ensure that they are providing full traceability and accountability on records with their FDA Compliance Software Solution.
Part of this requirement is the Electronic Signature, which captures the user’s digital signature for each step in the compliance management process.
These modules are tightly integrated to deliver a best-in-class GMP Compliance Software solution that will improve compliance and quality for your industry.
Et Q Connectors close the gap between production systems and the quality compliance system.
FDA Guidance - Medical Device FDA Principles of Software Validation The guidance has been developed mainly for development of software for medical devices.
However, it is a quite useful reference for other software development activities.
Et Q's unique modular approach provides unparalleled flexibility and automation.Authentication is required each time a document is processed..Life Sciences organization strive to achieve a state of inspection readiness, when automating their solution through their regulatory compliance software solutions.The manual has been developed in the 90's and looks rather old but the basics are very much up-to-date and strongly recommended to be followed in preparation for FDA audits.FDA Guidance for Industry and Reviewers Off-The-Shelf Software Use in Medical Devices This guidance document was developed to address the many questions asked by medical device manufacturers regarding what they need to provide in a pre-market submission to the FDA when they use off-the-shelf software (OTS).