In today's increasingly digital regulatory environment, proper management of electronic records and data integrity is fundamental to compliance. Our approach focuses on developing practical, risk-based strategies that satisfy regulatory requirements while considering your specific systems, processes, and business needs. We help you implement controls that ensure data reliability throughout its lifecycle without creating unnecessary operational burdens.
Our Part 11/data integrity services include, but are certainly not limited to:
Evaluation of existing electronic systems against 21 CFR Part 11 requirements to identify gaps.
Systematic review of processes and systems to identify data integrity vulnerabilities.
Creation of comprehensive data governance frameworks and policies.
Validation of electronic systems with focus on data integrity controls.
Strategic planning and implementation support to address identified data integrity issues
Creation of policies and procedures that establish consistent Part 11 compliance practices.
Development and delivery of targeted training to establish a data integrity culture.
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 (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.
