— within a September 5, 2023 FDA Warning Letter
Data integrity is a global requirement for the the regulated medical industries. The integrity of data is vital to guarantee the quality of life science studies and products — and to ensure patient safety.
To meet regulatory expectations, data must be attributable, legible, contemporaneous, original, and accurate: “ALCOA,” a term already familiar to those involved with clinical trials. Furthermore, data must meet the applicable requirements of GMP, GLP, GCP, QSRs, and ERES regulation such as 21 CFR Part 11.
Regulatory agencies have increased industry oversight regarding data integrity. The FDA, noting many Warning Letters and 483 observations, has produced draft and final guidance on the subject. EMA, WHO, and PIC/S have also published recent guidances on data integrity. ISPE has also recently updated GAMP 5 to explain how to comply in an efficient and comprehensive manner.
Valicom can provide your firm with experienced resources to help you learn your level of compliance with current regulations, and determine appropriate and efficient courses of action. We can assist you with:
A gap analysis, which identifies:
The regulations, guidances, and industry standards that apply to your products
Your present level of compliance
A prioritized, risk-based course of action for remediation and improvement
Training on data integrity topics
Policy and SOP development
System configuration advice
Computer system validation
Analytical instrument qualification
Responses to regulatory agency observations
For over 20 years, Valicom has provided our life science community with solutions to data integrity problems. Please contact us to learn more about how we can customize our services and expertise to assist you.