Life Science

Banetti's team has extensive experience with enterprise-level systems that require compliance with 21 CFR Part 11 and other federal and local regulations.

Our consultants are meticulous with documentation and carefully follow the procedures that guarantee you remain compliant and avoid any impacts associated with consent decrees or non-compliant instances.  We’ve devised a methodology to develop consistent, accurate validation protocols including Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ), along with instituting traceability matrices to ensure detailed protocol development tracking.  We can also help you combine Corrective Action/Preventive Action (CAPA) into your work management processes to make them seamless and lower the overall cost of your system.