Business Intelligence Solutions specializes in regulatory software testing and validation services.
Effective process validation contributes significantly to assuring drug and device quality. The basic principle of quality assurance is that a drug or device should be produced that is fit for its intended use. Clients minimize risk by ensuring that key business software systems are function and in compliance with applicable regulations.
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A successful validation program depends upon information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of the manufacturing process that result in products with the desired quality attributes.
Manufacturers should:
- Understand the sources of variation
- Detect the presence and degree of variation
- Understand the impact of variation on the process and ultimately on product attributes
- Control the variation in a manner commensurate with the risk it represents to the process and product
Each manufacturer should judge whether it has gained sufficient understanding to provide a high degree of assurance in its product development or manufacturing process to justify commercial distribution of the product.
Focusing exclusively on qualification efforts without also understanding the manufacturing process and associated variations may not lead to adequate assurance of quality.
Our regulatory software validation services offer the following distinct benefits:
- Evaluating regulatory compliance
- Indentifying associated risk factors Enhancing productivity through a reduction in application development and implementation time
- Improving scheudle visibility, assuring milestone achievement and project success
The validation and testing process not only focuses on sftware systems, but also evaluates the training and organization of your personnel and the effectiveness of your operating procedures.