Validating software fda
Et Q's robust security model ensures that your compliance software for both FDA and internal requirements has the highest security.Information access is controlled by a username, ID, password, form, form section, field and workflow.The audit trail includes the field's old value, new value, name of the user who made the change, and date and time.This provides value to companies in recording not only the field changes, but the requirements management of regulatory compliance software components, which provide increased visibility for validation activities associate with software changes.Et Q's QMS for Life Sciences is an integrated quality management and FDA Compliance Software system that exceeds GMP standards, including ISO 13485, ISO 14971 and 21 CFR Part 11 compliance requirements.Et Q's unique modular approach provides unparalleled flexibility and automation.Software and computer systems used in FDA regulated environments should be well controlled and validated.While there is not much detail in FDA regulations the agency has developed many guidance documents.
Life Sciences organization strive to achieve a state of inspection readiness, when automating their solution through their regulatory compliance software solutions.
Modules like Nonconformance Management and Complaint Handling Software connect to ERP and CRM systems to fully automate the creation and assignment of events.
Production systems can then be automatically updated throughout the event resolution process.
This means that they want to have a logical and traceable chain of custody and event management from event detection to event correction.
Et Q securely and automatically posts any and all field changes to a separate database.