In a time when regulatory requirements are increasing and drug safety is under scrutiny, Life Sciences companies cannot afford to make errors. Requirements will continue to increase, along with the penalties for failing to meet them. At HighPoint Solutions, we promote quality and compliance, providing the essential knowledge and services for implementing computer systems in a regulated environment. We have successfully made the transition from talking about these principals to deploying strategy, methodology, and technology to meet and exceed today’s standards.

Life Sciences companies are investing significant time and money to reap the highest benefits from information technology. While software and technology often automates operations and improves speed-to-market, it also can create compliance challenges. Regulations, standards and guidance must not only be interpreted and followed, but incorporated in a pragmatic manner in order to realize the best financial and productivity returns on information technology projects. Correctly implementing and supporting technology ultimately improves patient safety, creating an environment focused on the quality of care, not just day-to-day operations.

When taking on a compliance challenge, HighPoint Solutions sees it as an opportunity to bring value, competitive edge, and innovative thinking to our clients. With a strong base of knowledge including current FDA regulatory expectations, six sigma strategies, and technology, our team of senior-level consultants works to fix critical operational failures, minimize compliance risks, and maintain a state of control across all operational areas within an enterprise.

HighPoint Solutions builds-in quality and helps eliminates errors before they occur by validating systems, performing risk assessments and, most importantly, continually improving our project delivery framework and methodology.

Our team has proven expertise in the following areas:

• Computer System Validation
• Providing documented evidence a system meets its intended use.
• Utilization of a risk-based approach embracing recent FDA guidance, including 21 CFR Part 11.
• Industry accepted GAMP 5 approach or hybrid/custom approach to meet our clients’ SDLCs, including those incorporating Agile principles.
• Typical deliverables include Validation Plan, all testing Protocols (IQ, OQ, PQ, UAT), Traceability Matrix, Summary Reports, as well as all Specifications development (User, Functional, Design, etc.).
• System knowledge in the following functional areas: Laboratory Systems (Analytical, Development, and Quality Control); Clinical Systems; Pharmacovigilance and Drug Safety Systems; Regulatory and QA Systems; Manufacturing, Supply Chain Management, and Facilities Automation Systems; and Sales Operations Systems.
• Compliance Consulting and Guidance
• Strategic consulting based upon the impact of specific regulations on operations and associated information technologies. HighPoint’s team includes experts in GxP’s, Quality System Regulation, eRecords/eSignatures, Good Documentation Practices, PDMA, CDISC, SOX and many others.
• Quality Assurance support, including document review and Quality Coaching to project teams.
• Risk Assessments and Auditing
• Structured risk assessments of individual systems and/or portfolios of systems.
• Audits or assessments of internal processes and technologies, external partners and technology vendors.
• Project Planning, Project Management and Business Analysis Services
• Project Management of individual projects.
• Program Management of a project portfolio.
• Business Analysis for business process development, workflow harmonization, and requirements definition.
• Quality Management System Expertise
• Planning, configuration, validation, training, and maintenance of leading QMS software solutions.
• Turnkey services available or point assistance.
• User workshop facilitation, workflow and requirements definition, development, and rapid prototyping support.
• SOP Development
• Step by step procedural development across various functional areas, including providing templates provided as required.
• Training
• Individual and group training on various systems.
• Standard curricula available or custom course development.
• Train-the-trainer approach available.