Questionable practices and cGMP violations involving data integrity continue to increase during FDA inspections. Data integrity can be impacted by other systems and processes. Therefore, it is vital to understand your workflow (processes), necessary data requirements (manual and electronic), procedures, employee (human) competencies, and redundancies to simplify and improve the completeness, consistency, and accuracy of data.
The presence of unnecessary redundancy can make knowledge and data hard to understand, can be interpreted differently, and be difficult to maintain. If two (or more) items of information are redundant and share the same meaning or purpose, then inconsistencies in data, procedures, documentation, and change control can persist.
Simplification prevents this redundant representation of information, e.g. data (manual and electronic), batch records, forms, log books, procedures, labels, testing, trends, etc.
Malcom’s simplification methodology improves workflow and removes unnecessary redundancy from documentation, procedures, methods, systems, testing, data, and human knowledge.