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Validation Data Integrity

Validation Data Integrity

Data integrity is a critical regulatory requirement for the life science industry that is applicable to validation lifecycle. All information data and records generated during validation and the lifecycle of GMP systems is subject to data integrity regulatory requirements. Data integrity refers to the accuracy and consistency of stored data, indicated by an absence of any alteration in data between two updates of a data record. Data integrity is defined as the presence of accurate & reliable data and information. Data integrity requires data and information that is complete, consistent and accurate during…Read more »
Requirements Traceability Matrix in the Life Sciences Industry

Requirements Traceability Matrix in the Life Sciences Industry

Requirements Traceability Matrix is a regulatory requirement for the life science industry. The Requirements Traceability Matrix (RTM) is a document that links requirements throughout the validation process. The purpose of the Requirements Traceability Matrix is to ensure that all requirements defined for a system are tested in the test protocols. The requirements traceability matrix is usually developed in concurrence with the initial list of requirements and as the Design Specifications and Test Protocols are developed, the traceability matrix is updated to include the updated documents. Ideally, requirements should be traced to the specific…Read more »
Validation Regulatory Requirements and Challenges for the Life Science Industry

Validation Regulatory Requirements and Challenges for the Life Science Industry

Validation is a global regulatory requirement in the life science industry. The purpose of validation is to establish evidence that systems and processes will consistently yield results that meet predetermined specifications. The goal of the validation process is to ensure that systems and processes work as intended and they meet user requirements. Validation regulatory requirements are driven by regulations such as FDA 21 CFR Part 11, EU Annex 11 and many other country specific requirements for validation. The validation process is based on the foundation of a life-cycle approach for systems and processes…Read more »