Validations and Documentation
In today's regulatory healthcare environment, validation of processes and equipment are a necessity prior to implementation. AveraOpEx can assist your organization in the development of a full validation plan following regulatory and accreditation requirements (i.e. FDA, CMS, AABB, CAP, JCAHO, etc.). The plan may include a validation protocol, including the development of test cases if applicable, standard operating procedures and forms for all impacted processes and training documents. AveraOpEx will train your staff in the development of a master plan that may be used as a template for future validations.