Data Integrity and FDA Compliance

Excellent quality data has always been important to the US Food and Drug Administration because data integrity issues could lead to serious CGMP (current good manufacturing practices) violations. Dealing with poor data slows down FDA inspections and costs the agency, and ultimately the business, money. Unfortunately, data integrity issues are not uncommon, and enforcement in this area is increasing.

Data integrity is a critical focus area for FDA, because without basic data integrity controls, the agency cannot rely on that company's data or records to determine compliance, quality, or safety risks to consumers and patients. Data integrity is the cornerstone of FDA compliance, since data and documentation provide the only reliable information to determine a company's actions and intent. FDA trains investigators to detect signs of data problems and is looking more closely at facilities for signs of altered and doctored records.

In April 2016, FDA issued a draft guidance, Data Integrity and Compliance with CGMP Guidance for Industry, to clarify the role of data integrity in CGMPs for drugs. The guidance covers the agency's current thinking on creating and handling data in accordance with CGMP requirements. This was necessary because, in recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. The agency finds this troubling because ensuring data integrity is an important component of industry's responsibility to ensure the safety, efficacy, and quality of drugs, as well as FDA's ability to protect public health.

ARC Advisory Group clients can view the complete report at ARC Client Portal on www.ARCweb.com or Box.com

If you would like to buy this report or obtain information about how to become a client, please Request ARC Info

Keywords: Data Integrity, FDA Compliance, CGMP violations, ARC Advisory Group.