21 CFR Part 11 & Annex 11 Compliance

Part 11 Validation for LIMS, SCADA, and MES Systems

Part 11 Validation for LIMS, SCADA, and MES Systems Part 11 Validation for LIMS, SCADA, and MES Systems In the pharmaceutical industry, ensuring compliance with regulations and maintaining data integrity is paramount. The validation process for computer systems such as…

Training Requirements Under 21 CFR Part 11

Training Requirements Under 21 CFR Part 11 Training Requirements Under 21 CFR Part 11 In the rapidly evolving landscape of the pharmaceutical industry, rigorous compliance with regulatory standards is essential. The implementation and validation of computer systems governed by 21…

Creating SOPs for Part 11 Electronic System Management

Creating SOPs for Part 11 Electronic System Management Creating SOPs for Part 11 Electronic System Management The landscape of pharmaceutical validation is complex and requires a structured approach, particularly when integrating electronic systems under the purview of regulatory frameworks such…

Real-Life FDA 483s Related to Part 11 Non-Compliance

Real-Life FDA 483s Related to Part 11 Non-Compliance Real-Life FDA 483s Related to Part 11 Non-Compliance 1. Understanding User Requirements Specification (URS) & Risk Assessment Validation in the pharmaceutical industry begins with a clear understanding of user requirements, followed by…

How to Handle Electronic Record Migration and Archiving

How to Handle Electronic Record Migration and Archiving How to Handle Electronic Record Migration and Archiving Step 1: Understand Regulatory Requirements and Framework In the validation lifecycle of a pharma company, understanding regulatory requirements is paramount. Regulatory guidance documents such…

Part 11-Compliant Backup and Disaster Recovery Validation

Part 11-Compliant Backup and Disaster Recovery Validation Part 11-Compliant Backup and Disaster Recovery Validation The validation of computer systems used in the pharmaceutical industry is a crucial undertaking. With the increasing reliance on electronic systems for data management, ensuring compliance…

Time Stamp Synchronization and Record Authenticity

Time Stamp Synchronization and Record Authenticity Time Stamp Synchronization and Record Authenticity Validation in pharma companies is an essential aspect of ensuring compliance with regulatory standards. This article provides a detailed, step-by-step tutorial on the critical components of validation, focusing…

Requirements for User Access Controls in Part 11 Systems

Requirements for User Access Controls in Part 11 Systems Requirements for User Access Controls in Part 11 Systems User access controls are critical components of compliance with 21 CFR Part 11, which governs the use of electronic records and signatures…

Annex 11 Compliance Strategy for EU-Based Pharma Facilities

Annex 11 Compliance Strategy for EU-Based Pharma Facilities Annex 11 Compliance Strategy for EU-Based Pharma Facilities The validation of computerized systems is an essential component in ensuring compliance with regulatory requirements in the pharmaceutical industry. Notably, compliance with Annex 11…

How to Ensure Data Integrity in Electronic Systems

How to Ensure Data Integrity in Electronic Systems How to Ensure Data Integrity in Electronic Systems The validation of electronic systems is a critical aspect of ensuring compliance in the pharmaceutical industry. This comprehensive guide outlines the step-by-step process involved…