Page 15 - ADAMAS Brochure

ADAMAS can advise on and perform the full range of CSC and IT process audits— including IT-security and computer system validation audits and 21CFR11 compliance checks—to ensure all aspects of regulated computer system risk have been explored, understood and remediated where necessary. We are experienced in working with emerging technologies such as clinical informatics, blockchain and wearable medical technology.
Our range of CSC services includes:
▪ Computer System Compliance (CSC) auditing
▫ System-specific computer system validation audits ▫ Data centers
▫ Backup and data recovery
▫ Business continuity and disaster recovery
▫ IT security
▪ Computerized System Development Life Cycle (SDLC) process audits
▪ All aspects of system & application development processes, including planning, IQ/OQ/PQ, implementation and change control
▪ Computer System Compliance (CSC) consulting
▪ 21 CFR 11 compliance gap analysis
▪ Issue management and remediation
www.adamasconsulting.com