Documents, records and records management - James Vesper
James Vesper reviews the critical aspects of documents, records and record management. Documents like procedures, protocols, methods, and specifications provide instructions so people can perform tasks and make decisions safely, effectively, compliantly, and consistently. Records, such as batch manufacturing records, cleaning logs, and laboratory data sheets and notebooks provide evidence that actions were taken and decisions were (hopefully) made in keeping with procedures and GMP expectations. Reports, another type of documentation, provide specific information on a particular topic (like an investigation or one aspect of product development) in a formal, standardized way.