We provide more than just an audit and an audit report, we can help you understand the findings, priorities, and solutions. Just telling you what is wrong is never enough!

We can provide: Vendor Audits, Baseline Audits, Data Integrity Audits, Forensic Audits, Validation GAP Assessments, Risk Assessments, Part 11 Audits, Laboratory/Instrument Data Audits, Manufacturing System Audits, Business System Audits, Quality System Audits, Data Centers/Infrastructure/Cloud Audits, GAMP Audits, & Custom Audits (e.g. for cause, migration, system retirement)

We help clients provide assurance that their computerized systems are compliant with current regulations.

We can assist with any of your CSV needs, including:

• Validation Program Development & Implementation

• Validation Project Management

• Validation/Risk/CSA Strategies

• Validation Documentation

• Validation Testing

• CSV Remediation Programs

We can help you evaluate and mitigate data integrity issues before they become data problems.

KAI will work with you to ensure that your data meets regulatory requirements and ALCOA+ expectations.

We provide CSV training and mentoring services to help your entire team or entire company understand what is critical to be successful and in compliance with today’s standards.

In addition, we can develop and implement quality programs, software development life cycle (SDLC), and validation life cycle (VLC) methodologies, including all supporting procedures.

Our program development, training, and mentoring services are customized to your specific corporate culture and needs.