TM

“Combining science with regulatory knowledge for optimized systemic solutions.” ™ 

FDA Regulatory Compliance Advisors, Inc.

The complexity of the risk factors for data integrity issues have exponentially increased with the increasing use of automation and electronic records by the Pharmaceutical Industry.

"Avoid Costly Remediation Efforts"

However, the risk factors that can potentially compromise the integrity of the data are often misunderstood or overlooked, therefore resulting in the failure to implement adequate controls to prevent and detect data integrity issues. 

Data Integrity

Issues

Risk Factors 

Complexity

In the current regulatory environment, data integrity issues can compromise a company’s regulatory status and branding, and result in costly remediation activities.

FDA-RCA™ has a wealth of technical and regulatory experience to help your company understand the risk factors for data integrity issues, identify and remediate gaps, and develop robust, efficient systems and controls to prevent and detect data integrity incidents and avoid costly remediations.

​Unreliable data can have an adverse impact on product quality, and when the issue goes undetected, adulterated product may be released to the market in serious violation of the Food, Drug and Cosmetic Act.


Additionally, companies are at risk of becoming the target of intense regulatory scrutiny when FDA finds data integrity issues that the company has neither detected nor addressed themselves, with product recalls, FDA enforcement actions, and costly remediation activities.