Process Consulting Services

Procedure Development - Disciplined, effective work practices do not come about by accident. They are the result of experience, thoughtful planning, clear documentation, and effective training. We work with clients to develop and implement standard operating procedures (SOPs) and working practice documents that promote quality and productivity in programming and data management departments.

FDA Compliance - For our pharmaceutical clients, compliance with FDA regulations is a non-negotiable requirement. We offer expert knowledge of FDA regulations and guidance documents pertaining to the use of computers for clinical trials (e.g., 21 CFR Part 11), as well as emerging standards in the industry (e.g., ICH, MedDRA, CDISC). We evaluate current software applications and development procedures for compliance and help to remediate deficiencies.

Software Validation - Validation is not just about testing. Effective validation requires analysis of the unique risk profile presented by a particular software application and verification procedures to mitigate those risks throughout the development life cycle. We create software validation plans and procedures for new development projects. We also help clients with the revalidation of legacy software applications to bring them into compliance with current standards.