Assessing, mapping, and rewriting quality system documentation for pharmaceutical manufacturer

Problem: Quality system documentation for the client's global IT function was incomplete and poorly structured and organized, resulting in findings in an FDA audit.

Solution: A visual map was created to logically depict the processes and sub-processes supporting the quality elements identified in the Quality Manual.

All quality system documents were analyzed and categorized according to the processes and sub-processes they supported. Individual maps were then created to visually depict all the documents related to specific processes and sub-processes. Gaps, inconsistencies, redundancies, and obsolete documents were identified.

Procedures and work instructions were rewritten to improve comprehension and usability. The restructured documents were shorter and more modular, making it easier for readers to quickly find the instructions they need to complete specific tasks.

Guidelines for writing policies, procedures, and work instructions were developed to explain the different types of documents in the hierarchy and the information and level of detail that should be included in each.

Simplifying Quality System Documentation for Pharmaceutical Device Manufacturer

Problem: The policies and methods associated with the Quality Manual were difficult to understand and use, partly because too many cross-references were included.

Solution: Policies and related documents were reviewed to identify required information, theoretical and nice-to-know information, and redundant information. A new design for policy documents and easy-to-use templates were developed. The method template included process flow with corresponding steps, responsibilities clearly identified in each step, and only the information relevant to the task at hand.

Three components of the quality system were revamped as a result of the project: Change Control, Validation, and Sterilization. Over 70 procedures were rewritten. The amount of content in the documents was minimized by reorganizing information, eliminating redundancy, and capturing valuable information not essential to a procedure in a separate guidance document.

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