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

  1. Quality Management
    Keep clients in control of quality processes
  2. Learning Management
    Organization-wide employee training, including compliance
  3. Document Management
    A version-controlled repository for electronic approvals
  4. Adverse Event Management
    Supporting bulk uploads to the FDA or other agencies
  5. Clinical Management
    Systems and processes to address clinical trials quality
  6. Lab Information
    Record maintenance to support the discovery, clinical and manufacturing processes
  7. 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

How do specific regulations impact your operations? HighPoint veterans can guide you through GxPs, quality system regulations, eRecords/eSignatures, documentation, PDMA and other areas where compliance counts.

QUALITY MANAGEMENT SYSTEM DESIGN

You don’t need to tackle QMS solutions alone. HighPoint can get hands-on to plan, validate, implement, configure and maintain any leading quality management software solution, then train your team to keep your projects moving forward.

SOFTWARE QA & USER ACCEPTANCE TESTING

Efficient testing methodology comes with experience. We can design a right-sized testing effort based on risks specific to your business, then line up the resources necessary to expedite protocol/test script execution.

RISK-BASED COMPUTER SYSTEM VALIDATION

Find out if your current quality and compliance methodology is meeting FDA guidelines. We can assess where your company stands, then recommend and deploy changes and training to speed up your time to system deployment.

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.

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