Correction, Corrective Action, and Preventive Action (CAPA): Scope & Differences
Having a robust correction, corrective action, and preventive action system will help ensure regulatory compliance. Hence, most regulatory guidelines recommend implementation of a CAPA system. Our blog post on correction vs corrective action vs preventive action will...
What are Good Documentation Practices (GDP)? Basics & Pro Tips
Good documentation practices (GDP) describe best practices for creating and maintaining documentation in both paper and electronic format. These practices are used in pharmaceutical industry, medical device industry, and laboratories. It is basically a set of good...
CDSCO GCP Guidelines: Good Clinical Practice Guidelines
Good clinical practice (GCP) provides guidelines for designing, conducting, recording, and reporting clinical trials that involve human participants. GCP sets standards that need to be followed by conducting clinical trials. It ensures that the rights, safety, and...
10 Tips for Outsourcing Regulatory Affairs Team
Outsourcing is becoming increasingly common in pharmaceutical, medical device, and biotechnology, industries, especially in regulatory affairs and pharmacovigilance domains. Large and small companies alike are now turning to outsourcing vendors to manage...