Quality & Compliance

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

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

Learning Management:
Ensuring your organization is properly trained and compliant

Document Management:
Providing a version-controlled repository supporting electronic approvals

Adverse Event Management:
Enabling bulk upload of reports to the FDA and other agencies

Clinical Management:
Building the systems and processes to support quality needs for clinical trials

Lab Information:
Maintaining records that support Discovery, Clinical and Manufacturing processes

Information Security:
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