In terms of traceability, what does 'documented records' typically include?

Documented records in the context of traceability are comprehensive and encompass all relevant information that details the history of a product throughout its lifecycle. This includes records of raw materials, manufacturing processes, quality control checks, packaging, and distribution. Each of these elements is critical for ensuring that the product can be traced back through each stage of its production and distribution, thereby fulfilling regulatory requirements and ensuring product safety and compliance.

Traceability is essential in the pharmaceutical industry to quickly identify and address any issues that may arise with a product, such as recalls or quality defects. By maintaining thorough documented records, companies can provide evidence of compliance with Good Manufacturing Practices (GMP) and ensure that the product meets safety and efficacy standards.

The other choices are too narrow in scope. Product marketing materials, supplier contracts, and production schedules are all part of the broader system of documentation, but they do not encompass the full range of information necessary for complete traceability.