Data Integrity & ALCOA+ Compliance

Using Metadata to Ensure ALCOA+ Principles

Using Metadata to Ensure ALCOA+ Principles Using Metadata to Ensure ALCOA+ Principles In the pharmaceutical industry, ensuring data integrity is paramount for compliance with regulatory expectations and maintaining product quality. The ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and the…

How to Investigate Data Discrepancies in Validation Logs

How to Investigate Data Discrepancies in Validation Logs How to Investigate Data Discrepancies in Validation Logs The integrity of data generated from computer systems in the pharmaceutical industry is paramount for compliance with regulatory guidelines. Data discrepancies can lead to…

Cross-Referencing Audit Trails in Validation Reports

Cross-Referencing Audit Trails in Validation Reports Cross-Referencing Audit Trails in Validation Reports In the dynamic landscape of pharmaceuticals, data integrity is paramount. With regulatory bodies such as the FDA, EMA, and others underscoring the importance of adhering to Good Manufacturing…

How to Respond to Data Integrity Observations in FDA Audits

How to Respond to Data Integrity Observations in FDA Audits How to Respond to Data Integrity Observations in FDA Audits Step 1: Understanding the Regulatory Landscape The foundation of effective computer system validation (CSV) in the pharmaceutical industry begins with…

Documenting Calculations and Raw Data Sources Transparently

Documenting Calculations and Raw Data Sources Transparently Documenting Calculations and Raw Data Sources Transparently In the pharmaceutical industry, the validation of computer systems is a critical step in ensuring data integrity, compliance, and regulatory adherence. This article provides a comprehensive…

Creating SOPs for Validation Data Review and Approval

Creating SOPs for Validation Data Review and Approval Creating SOPs for Validation Data Review and Approval Step 1: Understanding User Requirements Specification (URS) and Risk Assessment Before initiating a computer system validation (CSV) process in the pharmaceutical industry, it is…