• Is WiseCLIN validated?

  Yes. WiseCLIN is developed and maintained under a documented software validation lifecycle. Qlarix provides a supplier validation package that includes relevant validation documentation, release information, change history and supporting system records. We can also support customer-specific validation activities, including intended-use assessment, UAT, PQ and traceability requirements.Few readers

• What standards and guidelines does WiseCLIN support?

  WiseCLIN is designed to support risk-based quality management principles described in key international clinical research guidelines, including: ICH E6(R3) ICH E8(R1) ICH Q9 standardsFew readers