Effective Compliance and Regulatory Writing
Effective compliance and regulatory writing combines many disciplines, suchas science, engineering, medicine, and law to create communications thatadvance medical, scientific, and manufacturing objectives. Regulatorydocuments often have multiple authors across several subject matter expertareas. This diversity frequently complicates a team's ability to write with aconsistent voice. As a rule, writing must be concise, precise, objective, andbalanced. Well-designed documents should provide information in such a waythe audience can understand and interpret easily.The objective of this textbook is to help authors and reviewers of regulatorydocuments to improve the quality of those documents. The material presentedcan assist personnel who write, review, or approve regulatory documents, suchas standard operating procedures, work instructions, policies, validationprotocols, batch records, device master records, annual product reviews,investigations, and so on. Effective writing of those documents can avoidauditors' or other regulatory bodies' inspection findings in such documentsthat could end up in opening deviation investigations or any other regulatoryaction. This material can be beneficial to personnel involved in developing anyregulatory documents for Manufacturing, Quality Assurance, Quality Control,Engineering, Regulatory Affairs, and Supplier Quality, among other areas.