Insights: GXP Compliance

Roadmap for compliance with 21 CFR Part 11
According to some analysts, the cost of 21CFR Part 11 compliance could vary from $5 million to $400 million, depending on a company's size and current state of systems. Companies with lots of computer systems that are not compliant with 21 CFR Part 11 must prioritize which systems to upgrade first...

Automating the process of Regulatory Compliance for Medical Devices
FDA regulatory compliance is a mission-critical requirement for medical device manufacturers. If the FDA finds a manufacturer to be non-compliant to or in violation of FDA rules, the consequences can be severe with warning letters, mandatory product recalls, temporary shut-downs, criminal penalties and fines depending on the severity of the violation...

Overview of 21CFR Part 11
Pharmaceutical, medical device, biotechnology and services companies are challenged to ensure regulatory compliance through all their operations...

Change Control in the FDA-regulated Industry
Change control is the most critical element in a pharmaceutical or biotech company's quality management system - inadequate change control procedures end up creating a huge risk of non-compliance...

Systems Validation for 21CFR Part 11 Compliance
21CFR part 11 requires that all systems that govern any cGXP process - including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), should be validated...