Paul Labas serves as Director of IT Compliance and CSV practice at IPS – Integrated Project Services, a life sciences industry consulting firm headquartered in Blue Bell, PA. Mr. Labas offers over 15 years of experience and expertise in all aspects of Computerized and Automated Systems Compliance, Computerized Systems Validation and Electronic Data Integrity.
Paul’s diverse experience includes high-risk projects such as establishment of organizational compliance frameworks, responses to consent decrees, and validation of systems in use by more than 100,000 people worldwide. Mr. Labas is involved on numerous ISPE initiatives, including formal peer reviews and authorship of industry guidance documents.
Sale!Risk-Based Approach to Computerized Systems Validation (CSV) has been a challenging concept to implement since the topic was introduced through GAMP5 in 2008. This vital fundamental activity is considered by Health Authorities to be the only acceptable way of...
Sale!Data Integrity and trustworthiness, the fundamental goals of computerized systems compliance and validation (CSV), have recently become a specific focus of severe and numerous enforcement actions by the US Food and Drug Administration (FDA) and other global regulatory agencies....