Improving the Lives of Patients and Their Loved Ones
Our client is a biopharmaceutical company dedicated to bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. The company has extensively invested in its pipeline and is dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones.
STRIVING FOR 21 CFR PART 11 COMPLIANCE
Our client recognized the need for ensuring its information systems implementation approach complied with 21 CFR Part 11, the U.S. Food and Drug Administration’s federal regulations that govern electronic records and electronic signatures. Because compliance with 21 CFR Part 11 requires both procedural governance and system-specific evidence of compliance with the governing procedures, the company asked us to perform a gap analysis of its IT systems.