What is data collection and Documentation control?
Data collection is a compilation of all the observations, results and information recorded and gathered while conducting GMP-related activities (like in Manufacturing, Warehousing, QC, QA, Engineering & maintenance, etc.)
While “Document Control” is a specific activity performed by the responsible persons (generally in QA) to ensure that current documents (such as SOPs, qualification, validation protocols, Batch Manufacturing & Packing blank records / Batch records), blank forms, logbooks & raw data notebooks (QC), etc. are used by the concerned persons in the organization for GMP related work. Therefore, these documents are issued by the responsible person(s) in QA in a controlled manner. This means their records of generation, issue, usage, return of unused document/forms, and reconciliation are maintained by the “Document control” cell in QA.