Data Integrity (DI) Audits and Training

QC Excellence Consultants brings extensive experience conducting Data Integrity (ALCOA+) audits across the globe, including in the US, India, and China. Beyond identifying gaps, we deliver actionable plans to help you close them and reinforce your Quality System.

We offer targeted training for all levels of technicians and operators on Data Integrity (DI), enhancing understanding of ALCOA and ALCOA+ principles. Key elements include:

Attributable: Traceable data to the individual responsible.

Legible: Data must be readable and permanent.

Contemporaneous: Recorded at the time of execution.

Original: First-recorded source data.

Accurate: Complete, consistent, and truthful data.

Additional attributes ensure records are Complete, Consistent, Enduring, and Available throughout their lifecycle.

With increasing regulatory focus on Data Integrity from FDA, EMA, WHO, TGA, and others, compliance with standards like 21 CFR 211, 21 CFR 58, and EudraLex is essential. Our services help you implement robust controls to meet these regulatory requirements and uphold the highest standards in your quality documentation and data integrity practices.