Imagine a solution so efficient it accelerates business growth. HighPoint has built that solution by creating a comprehensive quality framework for life sciences clients.

Quality Management

Keep clients in control of quality processes

Learning Management

Organization-wide employee training, including compliance

Document Management

A version-controlled repository for electronic approvals

Adverse Event Management

Supporting bulk uploads to the FDA or other agencies

Clinical Management

Systems and processes to address clinical trials quality

Lab Information

Record maintenance to support the discovery, clinical and manufacturing processes

Information Security

Access control and procedures that keep data and assets safe

HighPoint’s customer quality framework covers everything from infrastructure hosting and production operations to staff augmentation — with processes and systems validated at each step.

Beyond this framework, our experts support a broad range of quality and compliance needs, including strategic services, project execution, and operations support for life sciences clients looking for new efficiencies.

IT COMPLIANCE ROADMAP SUPPORT

QUALITY MANAGEMENT SYSTEM DESIGN

SOFTWARE QA & USER ACCEPTANCE TESTING

RISK-BASED COMPUTER SYSTEM VALIDATION

Leading Quality & Compliance

  • Robert Lorence

    Vice President, Quality & Compliance

    Robert Lorence

    Robert has more than 20 years of experience as a subject matter expert in regulatory requirements and quality management principles for computer systems, facilities, utilities, and equipment. His experience spans computer system validation project management, and regulatory compliance and training for pharmaceutical, medical device, and biotechnology firms.

    Prior to joining HighPoint, Robert was Director of Operations at CSSC, Inc., where he led large-scale remediation efforts and enterprise-wide computer system validation. Robert’s academic credentials include an MBA from Rider University and a BS in Electrical Engineering from Spring Garden College.