Malcom Associates | Data Integrity
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Data Integrity

cGMP violations related to data integrity continue to increase

Complete, consistent, and accurate data should be Attributable, Legible, Contemporaneously Recorded, Original or a true copy, and Accurate (ALCOA).

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.

Examples of redundancy:

  • The same “how to” work instruction is in an SOP and the batch record
  • The same data is recorded manually in the batch record and also captured electronically
  • Equipment cleaning is documented in a log book and batch record and/or form
  • Downtime reporting recorded in equipment log book and in the batch record