Cold chain validation
Paperless Cold Chain Validation
Life Sciences products must meet specific required storage conditions based on stability studies. These storage conditions must be maintained during shipping and distribution. The cold chain is a temperature-controlled supply chain. Equipment, logistics and monitoring are required to assure cold chain compliance. The associated cold chain validation must cover both the process and the equipment and must confirm that specified storage conditions are effectively met and monitored during the cold chain process. Product must meet specifications for safety, quality and effectiveness when it reaches the patient and an out of control cold chain can adversely affect the product quality attributes. All stages of the cold chain process must be validated and monitored to ensure that product quality will not be adversely affected. Typical validation processes are still paper-based making them inefficient, labour intensive and susceptible to data integrity and compliance risks.
Kneat’s e-validation solution will enable an end-to-end digital and fully transparent and compliant cold chain validation process.
Manage the entire Cold Chain Validation life-cycle:
- Validation plan management
- Systems register management
- System impact assessment
- Requirements capture and management
- Risk assessments
- Requirements traceability matrix
- Test protocol development (IQ, OQ, PQ/UAT)
- Paperless test execution with integrated deviation management
- Validation summary final report
- Real time validation metrics
- Validation status monitoring and periodic review management
- Part 11/Annex 11 environment
The benefits are many: from cycle time and cost reductions to quality and compliance
- Productivity improvement and cycle time savings
- Best practice that can be leveraged over and over
- Paper records are eliminated – instant central access to all records online
- Records and versions cannot be misplaced
- Potential for data integrity issues is minimize with focus on data quality throughout the life-cycle
- Status dashboard with instant macro and micro visibility into all aspects of the process in real time
- Protocol GDP errors minimized
- Audit ready in real time
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