Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories

Data integrity is the hottest topic in the pharmaceutical industry at the moment. Global regulatory agencies have issued six guidance documents in the past couple of years, however all documents are vague and to not contain detailed examples or advice to help regulated laboratories to implement policies, procedures and processes to ensure integrity. The aim of this book is to provide practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries. It is designed for analytical chemists and scientists working in regulated laboratories, management and senior management roles, primarily in the pharmaceutical industry and consultants who will benefit from the practical guidance provided.