Tag: iso 11137 1

Electronic Record Control in Cloud-Based Platforms

Electronic Record Control in Cloud-Based Platforms Electronic Record Control in Cloud-Based Platforms In the evolving landscape of pharmaceutical and medical device manufacturing, electronic record control in cloud-based platforms has become instrumental in ensuring compliance and data integrity. This article presents…

How to Manage Service Level Agreements in Cloud CSV

How to Manage Service Level Agreements in Cloud CSV How to Manage Service Level Agreements in Cloud CSV Cloud-based Computer System Validation (CSV) has become a pivotal element for the pharmaceutical and medical devices industry, particularly as organizations migrate to…

Tech Transfer Timelines for Qualification Activities

Tech Transfer Timelines for Qualification Activities Tech Transfer Timelines for Qualification Activities In the pharmaceutical and medical device industries, effective validation processes are crucial to ensure quality, safety, and efficacy. The adherence to international standards such as ISO 11137-1 is…

Equipment Relocation and Requalification Best Practices

Equipment Relocation and Requalification Best Practices Equipment Relocation and Requalification Best Practices Equipment relocation and requalification in the medical device industry are critical processes that ensure compliance with regulatory standards, maintaining the quality and safety of products. This comprehensive step-by-step…

Continuous Process Verification in Lifecycle Validation

Continuous Process Verification in Lifecycle Validation Continuous Process Verification in Lifecycle Validation Continuous Process Verification (CPV) represents a paradigm shift in the lifecycle validation approach for pharmaceuticals and medical devices, essential for ensuring quality in a stringent regulatory environment. This…

How to Align Process Validation with Product Lifecycle

How to Align Process Validation with Product Lifecycle How to Align Process Validation with Product Lifecycle Understanding the Validation Lifecycle The validation lifecycle is a critical component of the pharmaceutical and medical device industries. It ensures that products meet quality…