Data integrity is a global requirement for the the regulated medical industries. The integrity of data is extremely important to guarantee the quality of life science studies and products — and to ultimately ensure the safety of patients.
To meet regulatory expectations, data must be attributable, legible, contemporaneous, original, and accurate: “ALCOA,” a term already familiar to those involved with clinical trials (as well as those in the aluminum industry). 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 The FDA, noting many Warning Letter and 483 observations, produced a draft guidance on the subject in 2016. FDA published the finalized guidance in December 2018. EMA, WHO, and PIC/S have also published recent guidances on data integrity.
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 provide 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 17 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.