Validation services

Validation requirements and regulatory initiatives, such as 21CFR11, add cost to manufacturing and may limit the number of reliable vendors available to you. SYMETIX® offers effective equipment and process validation.

For a life sciences industry such as pharmaceutical manufacturing—for years the most regulated industry in the world—the ability to manage complex documentation necessary for regulatory compliance is critical in getting your product into customers’ hands. Costs of noncompliance—not to mention delay to market—can be steep.

SYMETIX® solutions are fully and quickly validated to customer protocols. They enhance product traceability and identification—and with less human intervention in manufacturing, make validation less complex.

Vantyx® inspection systems are FDA 21CFR11 compliant and—as with Optyx®/SG automated inspection systems and other SYMETIX® technologies—are designed to meet GAMP 4 guidelines. SYMETIX® solutions enable manufacturers to achieve the highest level of diligence while maximizing product quality, throughput and cost effectiveness.
While not as formally scrutinized to date, the nutraceutical industry can see the day ahead when some degree of FDA validation will be required for these products as well. SYMETIX® is prepared to support our nutraceutical customers’ needs as their validation requirements evolve.