Our team is trained in the SDLC methodologies and provides solutions that are 21 CFR Part 11, EU Annex 11, and cGxP compliant based on industry best practices such as GAMP5 and ALCOA+. All of our projects and consultants are managed by highly trained professionals with laboratory informatics, laboratory system and validation experience. Our offerings include Laboratory Compliance Assessments where our staff can perform a thorough review of the Laboratory systems and their associated data paths to determine alignment to Compliance and Data Integrity Standards.