FDA

Annex 11 and 21 CFR Part 11: Comparisons for International Compliance

The two essential resources regarding the validation of computer systems are: the FDA’s 21 CFR Part 11 and the EMEA Guidelines to Good Manufacturing Practice (GMPs) - Annex 11, Computerized Systems.

21 CFR Part 11 Compliance Checklist

If your company is planning to convert to an automated system for managing documents and processes, make sure the new system meets the needs outlined in this 21 CFR Part 11 Compliance Checklist.

FDA/ISO Compliance Toolkit

Medical device managers are complying with FDA requirements and better aligning with evolving industry trends by recognizing the value of moving to a digital quality management system.

Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments

The U.S. Food and Drug Administration has released data on the most common observations it makes during inspections of pharmaceutical facilities. This white paper explores the top 10 deficiences.

FDA Inspections of Clinical Investigators: Are You Ready?

In the United States, the Food and Drug Administration (FDA) has a number of guidances that are meant to strengthen its oversight of clinical investigators and clinical trials.

Validating Software Systems to Comply with CGMP and 21 CFR Part 11 Regulations

11 Free Resources to Boost Your Medical Device FDA Readiness

This FDA Readiness Toolkit is designed to help medical device manufacturers simplify compliance with FDA standards and streamline quality-related processes.

How to Successfully Complete an FDA Inspection

This white paper provides an overview of the inspection process, describing the preparation for an inspection, what will happen during an inspection, and what to expect after an inspection occurs.

The Value of Studying and Utilizing FDA's QSIT Manual

The FDA’s approach to the inspection process of medical device manufacturers, Quality System Inspection Technique (QSIT), embraces a top-down inspection of a firm’s QMS.

MasterControl eMDR™

The FDA requires medical device manufacturers to report any adverse events to the agency.

11 Free Resources to Boost Your FDA Readiness

A collection of related videos, whitepapers, articles, and product data sheets to simplify compliance with FDA standards by streamlining quality-related processes.

12 Free Resources to Boost Your Pharmaceutical FDA Readiness

This FDA Readiness Toolkit is designed to help pharmaceutical companies simplify compliance with FDA standards and streamline quality processes.

Compliance with FDA's Good Tissue Practices

This Q&A breaks down the key requirements of 21 CFR Part 1270 (Human Tissue Intended for Transplantation) and Part 1271 (Human Cells, Tissues, and Cellular Tissue-Based Products).