Validation
Validation Management Software
Novatek’s Validation Management software creates a roadmap for validation practices that goes beyond customer processes, and promotes unified data views across any organization.
The system is designed for variety of processes some of which that include:
- Validations
- Workload Forecasting
- Sample Inventory
- Sample Management
- Control & Distribution
- Testing of Validation Samples
This type of information is required for validation cost-to-serve analyses, which produce great insights into compliance, methodology and profitability.
The FDA Defines Validation As:
“Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”
Novatek’s Validation Management software assists companies in creating, managing, and executing their master protocols in a secure environment with version control.
The FDA Further Specifies:
“Validation protocol: A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.”
Novatek’s Validation Management software provides the capability to create dynamic and traceable validation process steps. Each step in the protocol can be generated, executed, and the test result can be imported into the necessary reports. The system also allows for sample scheduling, pulling and testing. This process ensures that no samples are missed and as a result no redundant validation steps occur.
Novatek’s Validation Management software is ideal for both business and IT executives looking for software solutions to act as validation knowledge data centers. In the healthcare and life science industries Novatek’s Validation Management software will combine validation knowledge from functions involved in new product development and launch processes into a data center accessible on an enterprise-wide basis.
Novatek’s Validation Management allows for centralization of up to date validation information across all pertinent departments within any organization.
Features & functions
- Manages all validation types (Cleaning Validation, Process Validation, equipment & media qualification, etc.)
- Manages validation sample schedules, sample points & test results
- Provides extensive trending & statistical analysis for early warning of manufacturing quality deviations
- Secures validation documents from unauthorized changes
- Works in conjunction with a text editor
Key benefits
- Increases overall validation efficiency & productivity
- Eliminates manual verification &reduces human errors
- Prevents costly shutdowns & manufacturing delays
- Fast implementation, IQ/OQ validation, ease of upgrade & support
- Manages all validation types
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