This book deals with a topic of critical importance for compliance with record-keeping regulations in pharmaceutical and medical device industries. It presents more than 750 questions and answers about documentation management, whether electronic or paper-based. It defines, through a Q&A approach, what document management actually is, and why it should be a core discipline in the industry. Questions and responses also address electronic system selection and validation, system security, user accountability, and audit trails, as well as standard operating procedures for supporting document systems. Finally, responses demystify the meaning of binding regulations.
Janet Gough has extensive experience as a consultant to thepharmaceutical, biotech, and medical device industries. She designssystems for compliance with binding regulations, and conductstraining accordingly. She assists companies in the preparation ofdocuments including development reports, procedures, clinicaldocuments, and regulatory fillings. Ms. Gough is the author ofseven other books. David Nettleton is a compliance, documentation, andcomputer system validation consultant involved with thedevelopment, purchase, installation, operation, project management,and maintenance of computerized systems used in regulatedapplications (GMP, GCP, and GLP). He is the author of three otherbooks.