IQ/OQ for Software Systems: What Needs to Be Documented IQ/OQ for Software Systems: What Needs to Be Documented In the highly regulated pharmaceutical and biotechnology industries, ensuring compliance through rigorous validation procedures is paramount. This article provides an in-depth, step-by-step tutorial on the Integrated Qualification (IQ) and Operational Qualification (OQ) for software systems, underpinned by the standards set forth in relevant regulatory guidance, including FDA’s Process Validation Guidance, EU GMP Annex 15, and ICH Q8-Q10 guidelines. As quality assurance (QA), quality control (QC), and validation teams navigate the complexities of analytical method validation, adherence to these guidelines is critical. This…

Macro and Formula Locking Techniques for GMP Spreadsheets Macro and Formula Locking Techniques for GMP Spreadsheets In the realm of pharmaceutical manufacturing and quality control, ensuring data integrity and compliance is paramount. Effective gxp validation plays a critical role in achieving this goal. This article serves as a comprehensive step-by-step tutorial, focused on how to implement macro and formula locking techniques in GMP spreadsheets, while aligning with regulatory expectations including FDA guidelines and Annex 15 qualification and validation. Step 1: User Requirements Specification (URS) and Risk Assessment Before any validation process commences, defining user requirements clearly is essential. The User…

Validation of Off-the-Shelf Software in GxP Systems Validation of Off-the-Shelf Software in GxP Systems In today’s regulated environments, the validation of off-the-shelf software in Good Practice (GxP) systems is crucial for compliance and maintaining data integrity. This article serves as a comprehensive, step-by-step tutorial for Quality Assurance (QA), Quality Control (QC), Validation, and Regulatory Teams engaged in system validation. We will cover each phase of the validation lifecycle from process design through revalidation in alignment with regulatory expectations, including FDA guidelines, EU GMP Annex 15, ICH Q8-Q10, and related standards. Step 1: Understanding User Requirements Specifications (URS) & Risk Assessment…

Spreadsheet Inventory and Risk Assessment Template Spreadsheet Inventory and Risk Assessment Template This article provides a comprehensive step-by-step tutorial on implementing a spreadsheet inventory and risk assessment within the context of kneat validation. This approach aligns with regulatory frameworks, including GMP, FDA, and EMA guidance, establishing a solid foundation for system validation in pharmaceuticals. Step 1: Understanding the Validation Lifecycle Before embarking on any validation activity, it is essential to comprehend the validation lifecycle. The validation lifecycle is a structured approach that ensures all processes and systems meet regulatory requirements and perform their intended functions accurately. Within the pharmaceutical industry,…

How to Validate Excel Calculations Used in GMP Operations How to Validate Excel Calculations Used in GMP Operations In the highly regulated pharmaceutical industry, the accuracy and reliability of data generated through Excel calculations are paramount. This article provides a comprehensive, step-by-step tutorial on validating Excel calculations aligned with FDA, EMA, and ICH guidelines, focusing on bioanalytical method validation. The readers will find clear instructions and best practices tailored for QA, QC, Validation, and Regulatory professionals. Step 1: User Requirement Specification (URS) and Risk Assessment The validation lifecycle starts with the creation of a User Requirement Specification (URS). The URS…

Spreadsheet Validation in Pharma: Step-by-Step Guide Spreadsheet Validation in Pharma: Step-by-Step Guide In the pharmaceutical industry, the integrity and reliability of data generated through software applications, especially spreadsheets, is critical. This article outlines a comprehensive step-by-step guide for validating spreadsheet applications, focusing on essential elements such as process design, qualification, and continued process verification (CPV). The validation steps described herein are aligned with current guidelines, including the FDA Process Validation Guidance, EU GMP Annex 15, and ICH Q8-Q10. Step 1: User Requirements Specification (URS) & Risk Assessment The first step in spreadsheet validation is to develop a clear and concise…