{"id":2077,"date":"2022-04-28T17:40:32","date_gmt":"2022-04-28T12:10:32","guid":{"rendered":"https:\/\/www.kewaunee.in\/blog\/?p=2077"},"modified":"2024-07-15T14:34:55","modified_gmt":"2024-07-15T09:04:55","slug":"good-documentation-practices-for-laboratories-an-overview","status":"publish","type":"post","link":"https:\/\/www.kewaunee.in\/blog\/good-documentation-practices-for-laboratories-an-overview\/","title":{"rendered":"Good Documentation Practices for Laboratories \u2014 An Overview"},"content":{"rendered":"

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Good Documentation Practices For Laboratories An Overview<\/span><\/h1>[vc_column_text]Laboratory compliance is an often talked about topic but rarely given much heed to in practice. To ensure that your laboratory is following the right documentation practices, refer to our infographic below that details the different Good Documentation Practices.<\/span>[\/vc_column_text][vc_row_inner][vc_column_inner][vc_column_text]<\/p>\n

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Key Pointers<\/strong><\/td>\nAspects to consider<\/strong><\/td>\n<\/tr>\n
Why is it needed?<\/span><\/td>\n\n
    \n
  • The main purpose is to ensure that there is an audit trail for every single task in the laboratory<\/span><\/li>\n
  • It can be reagent procurement, material sourcing, experimentation, storing, disposal<\/span><\/li>\n
  • As long as it\u2019s documented, there\u2019s proof showing that the task happened<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
What does it cover?<\/span><\/td>\n\n
    \n
  • Data accuracy \u2014 Make sure data is recorded properly, stored properly, no error in entries, cross checked<\/span><\/li>\n
  • Data integrity \u2014 Data needs to be true, recorded in the presence of a witness, relevant to the recording equipment and cannot be changed after recording<\/span><\/li>\n
  • Data recording \u2014 Continuously recorded, real time records with data stamps<\/span><\/li>\n
  • Data legibility \u2014 Must be legible, clear, and accessible<\/span><\/li>\n
  • Identification \u2014 The data must be recorded along with personnel\u2019s name; information must be discreet and accessed based on authority & credentials<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Types of documents<\/span><\/td>\n\n
    \n
  • Types: Primary documents, Supporting documents, Subsidiary records, Quality control records<\/span><\/li>\n
  • Examples: Analytical Methods, Batch Records, Bills of Materials (BOMs), Certificate of Analysis (CoA), Certificate of Compliance (CoC), Laboratory Notebooks, Logbooks, Policies, Standard Operating Procedures, Test Methods, Training Documentation, Validation Documents (IQs, OQs and PQs)<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Additional aspects<\/span><\/td>\n\n