The Quality and Compliance practice delivers services and solutions to enhance our clients’ quality frameworks. We leverage the specialties of our practice, other HighPoint practices, and our business partners to deliver what is needed, when it is needed. Our ultimate goal is to ensure we are the last quality consultants our clients need to engage. Our primary solution categories are Quality Framework Solutions, Strategic Services, Project Execution and Operations Support.
Quality Framework Solutions are services within the Quality realm that meet specific client quality needs.
Customer Quality Framework: A ‘Total Solution’ where HighPoint acts on a client’s behalf to oversee all aspects of their quality systems including infrastructure hosting, production operations and staff augmentation
Quality Management: Maintaining all of your quality processes to help you maintain control
Ensuring your organization is properly trained and compliant
Providing a version-controlled repository supporting electronic approvals
Adverse Event Management:
Enabling bulk upload of reports to the FDA and other agencies
Building the systems and processes to support quality needs for clinical trials
Maintaining records that support Discovery, Clinical and Manufacturing processes
Keeping data and assets safe and secure through access control and procedures
Validation and Testing:
Ensuring that processes and systems are verified to work as desired and as required