Process Consulting Services
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
and productivity in programming and data management departments.
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
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
applications and development procedures for compliance and help
to remediate deficiencies.
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.
with the revalidation of legacy software applications to bring
them into compliance