Our systematic Validation process is performed for the benefit of the customers and users to ensure that the product functions in the expected manner when placed in the intended environment. We follow the following approach in conducting any product validation process.
- Validation Planning
- Validation Preparation
- Conduct Validation
- Analyze Results
Product Validation Planning
- We determine the type of validation that must be used for the particular aspect of the product that is being validated.
- Review the validation plan with the customer in order to confirm that the end product is being validated in the required environment and under the specified operating instructions.
Product Validation Preparation
In preparation for product validation, we perform the following:
- Validation plan
- Procedures for each type of validation
- Purpose and objectives of steps within the validation process
- Any necessary pre and post-test actions
- Criteria for success vs. failure
- Well-defined requirements to compare against validation
- Product to be validated
- Set of customer expectations
- Any supporting resources
- Any measurement and recording tools
Conduct Product Validation
We follow the procedures from the validation plan; take any necessary measurements, and record resulting data needed to determine whether or not validation was successful.
The following elements are determined from conducting the product validation:
- Supporting information to confirm that appropriate results were obtained
- Whether the products comply with customer expectations
- Whether the product was properly integrated with validation environment according to customer expectations
- Whether the product functions with any required interfaces
Analyze Product Validation Results
Product validation is a wasted effort if the results are not analyzed
- Analyze data for quality, correctness, integrity and consistency
- Compare the actual validation results to the expected results
- Identify any deficiencies that arose in the validation process
- Determine corrective actions needed to address any deficiencies
- Record all analysis data and prepare to repeat validation as needed
Finally, we validate each component in the product to confirm that it meets customer expectations before it is integrated into the final product. If a deficiency is discovered during validation, we ensure its correction by performing a thorough “Regression Testing”, so that it does not create a new issue with a product that previously operated without issue. We thoroughly document throughout the validation process in order to have proof that customer expectations have been met.
