Data integrity has become a primary focus area for regulatory agencies worldwide, with significant compliance implications. Our approach focuses on evaluating both the technical controls and quality culture that support data reliability. We examine your systems and processes through the lens of current regulatory expectations, helping you identify and address potential vulnerabilities before they become compliance issues that could impact product approvals or regulatory standing.
Our data integrity audit services include, but are certainly not limited to:
Focused assessments of laboratory systems, equipment, and data handling practices.
Comprehensive evaluations of production systems and records for data reliability.
Detailed reviews of electronic systems against Part 11 requirements and data integrity principles.
Evaluation of policies, procedures, and oversight mechanisms that support data integrity.
In-depth examination of system audit trails for appropriate configuration and proper use.
Verification of data integrity during system transitions and migrations.
Evaluation of organizational awareness, training, and data integrity behaviors.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant/contractor (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.
