Registrar Corp has been a leader in regulatory compliance for over 20 years. Learn more about our international services, software, and trainings.
Registrar Corp has been a leader in regulatory compliance for over 20 years. Learn more about our international services, software, and trainings.
Registrar Corp has been a leader in regulatory compliance for over 20 years. Learn more about our international services, software, and trainings.
Compliance with complex regulatory requirements – such as FDA 21 CFR Part 11 – requires much more than password protection and restricting user access to files and folders on a corporate network. ZONE3® Prohas built-in capabilities that directly support the operational requirements of a regulato...
Makromed provides Process Validation and Test Method Validation, Software Validation, Complaint Handling and Adverse Event, CAPA and Nonconformance, Internal and Supplier Audit, Employee Training Software and Consulting Services for Medical Device, Diagn
The author reflects that although enterprise resource planning (ERP) and customer relationship management (CRM) software systems help manufacturers conform to regulatory compliance, many of them are not fully integrated and do not provide the needed data to prove conformance. He suggests that ERP and...
“should consider the least burdensome approach”. This recommendation allows us to consider the use of agile methodologies to deliver validated software that will pass compliance audits. In fact, our clients have used both agile and formal development methodologies to deliver compliant software, with...
We understand how disruptive change can be in your compliance environment. However, software applications must be upgraded to meet your expanding business requirements, new technology, and industry demands. Arena Validate enables you to spend less time testing and documenting each release of Arena’s ...
Compliance with regulatory requirements is a business-critical need that must be maintained, and the FDA recognizes that a technically advanced software solution can help companies manage compliance. 遵守法规要求是必须维护的关键业务需求,而且FDA认识到技术上先进的软件解决方案可以帮助公司管理合规性。
Benefits of FDA Software Validation FDA software validation offers numerous benefits that contribute to regulatory compliance, patient safety, product quality, risk mitigation, productivity, trust-building, and cost-effectiveness in developing and deploying software solutions in the healthcare industry. The ...