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


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