computer validation in pharmaceutical industry – Page 2

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…

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…

Aligning the VMP with Quality Risk Management Principles

Aligning the VMP with Quality Risk Management Principles Aligning the VMP with Quality Risk Management Principles The pharmaceutical industry operates under stringent regulatory oversight, whereby quality and compliance are paramount. A critical component of ensuring product quality and patient safety…

VMP as a Living Document: Regulatory Implications

VMP as a Living Document: Regulatory Implications VMP as a Living Document: Regulatory Implications The validation master plan (VMP) serves as a crucial framework for ensuring compliance within the pharmaceutical industry, especially concerning computer validation in the pharmaceutical industry. As…

QA Role in Reviewing and Owning the VMP Document

QA Role in Reviewing and Owning the VMP Document QA Role in Reviewing and Owning the VMP Document The Validation Master Plan (VMP) serves as a cornerstone document in the pharmaceutical industry, directing the validation efforts for all processes, systems,…

How to Handle Software Updates and Revalidation

How to Handle Software Updates and Revalidation How to Handle Software Updates and Revalidation In the rapidly evolving landscape of the pharmaceutical industry, ensuring compliance with regulatory requirements while managing software updates and revalidation has become a critical focus for…

Validating Data Transfers in Software Systems

Validating Data Transfers in Software Systems Validating Data Transfers in Software Systems Validating data transfers in software systems is a crucial aspect of ensuring compliance and integrity in the pharmaceutical industry. This step-by-step tutorial outlines the validation lifecycle, detailing essential…

How to Document Equipment Reuse Across Sites

How to Document Equipment Reuse Across Sites How to Document Equipment Reuse Across Sites In the pharmaceutical industry, the validation of computer systems is crucial for ensuring compliance with regulatory standards and ensuring product quality. This article provides a detailed…

Template for Tracking Qualification Deviations

Template for Tracking Qualification Deviations Template for Tracking Qualification Deviations This article provides a comprehensive step-by-step tutorial on the qualification lifecycle, emphasizing the critical role of computer validation in the pharmaceutical industry. Each step aligns with the established guidelines from…