Audit & Evaluation
Akility conducts Audits, Gap Analysis and Evaluations dedicated to Life Sciences companies. They are aligned with the current regulatory requirements and are based on ISO 19011 requirements.
IT Diagnostics
Infrastructure & Application mapping
Information Security (ISO 27001)
IT Quality Documentation Review
Regulatory Audit
Validation review
FDA 21 CFR Part 11, 210, 211
Eudralex Annex 11, Annex 15
Data Integrity & Protection Audit
Data Integrity Assessment
Computerized Systems Compliance Audit
GDPR
Third Party Audit
Audit of Computerized Systems Suppliers
Audit of Software Suppliers
Third party Data Integrity Audit
IS Maturity Evaluation
Organisation maturity vs Regulation, Processes, Technology and Personnel
Computerized practices and procedures
Report & Action Plan
Each Audit or Evaluation is concluded by a detailed Report and an Action Plan to reach the expected compliance level