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Validation Regulatory Requirements and Challenges for the Life Science Industry

Blog Home | Published: August 30, 2017

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 in the life science industry. In a validation lifecycle approach companies are required to manage and control the process from the early stages into validation and GMP operations. To properly manage, control and meet regulatory requirements companies are required to have policies, procedures and standards that define the requirement of the process and provide specific instructions about how to meet those requirements.

During the validation lifecycle process companies generate a significant number of paper-based documents, records, data and information. These documents and records are typically found in binders which are stored in document archives onsite and offsite facility provided by a third-party vendor.

The traditional approach for managing the validation lifecycle process is based on paper-based records which creates a significant amount of challenges which include inefficiencies and inability to follow and enforce approved procedures. Managing, storing, archiving paper-based records is not cost efficient and requires an entire department to manage all the information generated during the validation lifecycle including third party vendors for off-site document archival and storage services.

Because the validation lifecycle process is mostly a manual process it can’t be automated to improve efficiency and reduce cost.

Because all records are paper-based information is not integrated and readily available for review, approval and assessments of the validated state during re qualification activities.

Managing the validation lifecycle with paper-based documents create a significant amount of compliance risk for the life science industry. The compliance risk is related to the challenge that data is controlled and secured using procedures instead of technical controls which are more reliable.

Traditional cleaning validation can be very challenging due to the inefficiencies, compliance risk, lack of data integration, inability to access and review data in a single repository.

ValGenesis provide a fully electronic validation life cycle management system that eliminate paper, fully automates the process and enables the ability to enforce validation requirements found in procedures.

Summary

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.