Qualification & Validation


Validation is the documented act of proving that any procedure, process, equipment, material, activity or system actuallyleads to the expected result. Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.

According to the Food and Drug Administration (FDA), the goal of validation is to establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

SUNISTA GROUP owns in-house subsidiary by the name BIO CLEAN which is an ISO 9001:2015 certified company established in 2016. The company known for its economical and reliable Calibration, Validation & AMC Services serving to all industries.

Our portfolio includes Calibration Services, Clean Room Qualification & validation, Compressed Air Validation, HVAC Validation, PLC Validation, and Temperature Mapping etc.

Our Services Complies as per USFDA, EUGMP, WHO, MHRA, & GMP guidelines.