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Validation documents are a critical part of the Quality System Optimization program for real-time release of pharmaceutical water.
Validation Documents
The Quality System Optimization (QSO) for Real-time Release of Pharmaceutical Water program from GE Analytical Instruments has four main components: a one-day introductory workshop, consulting, validation services, and validation documentation. The validation documentation, including protocols, are essential for understanding your current state process characteristics and defining your desired future process state. If you have implemented — or are considering implementing — a real-time release program at your facility, the following documents can help you verify your process validation strategy.
- Method Validation - Specificity and Robustness Protocols (for the Sievers 900 and 500 RL Series TOC Analyzers)
- Method Comparability and Transfer
- Measurement System Equivalency
- Historical Data Collection and Review
- Point of Use Quality Verification
These documents are available separately or as a full package. Contact us for more information.