CertusLS
CertusLS helps life science companies stay compliant and pass audits with clear, actionable guidance. It uses CSV-focused validation and regulatory expertise aligned with GAMP5 and V&V to ensure systems meet requirements. The company operates as a B2B service and offers ISO 9001, ISO 13485, 21 CFR Part 11/Annex 11, and 21 CFR Part 820 compliance programs, plus AI-driven ISO 42001 certification, eQMS, ALM, and ISMS implementations. It also provides ISO 27001/27017 security frameworks and ISO 14971 risk assessment to cover life sciences risk management. The target market includes pharmaceutical, biotech, and medical device firms seeking scalable compliance programs.
CertusLS
CertusLS helps life science companies stay compliant and pass audits with clear, actionable guidance. It uses CSV-focused validation and regulatory expertise aligned with GAMP5 and V&V to ensure systems meet requirements. The company operates as a B2B service and offers ISO 9001, ISO 13485, 21 CFR Part 11/Annex 11, and 21 CFR Part 820 compliance programs, plus AI-driven ISO 42001 certification, eQMS, ALM, and ISMS implementations. It also provides ISO 27001/27017 security frameworks and ISO 14971 risk assessment to cover life sciences risk management. The target market includes pharmaceutical, biotech, and medical device firms seeking scalable compliance programs.