Guidelines for Data Integrity Practices SOP-0000012

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Across
  1. 3. A commonly used acronym for “Attributable, Legible, Contemporaneous, Original and Accurate” which puts additional emphasis on the attributes of being Complete, Consistent, Enduring and available
  2. 6. Staff will strive to ensure that data and records are completed at the time and date at which the activity or event has occurred.
  3. 8. All __________ systems which generate electronic data and/ or records should be validated for their intended use and the ability to recognize invalid or altered records.
  4. 9. _________ and misrepresentation of a document/data shall be considered an offense and the nature of the punishment shall be at the discretion of management.
  5. 11. Discarding original data generated for GMP purposes is _________.
Down
  1. 1. Data, records, actions, and events, including review and approval of records, must be uniquely attributable to the person or person(s) completing the data, records, actions, or events through initials, full handwritten signature.
  2. 2. Data should be recorded on a long-lasting, durable storage media.
  3. 4. All original records, including true or certified copies, must be maintained for the required record retention period. Refer to SOP-0000207, Records Retention Schedule. True or certified copies of original paper records should be initialed/signed and dated by the person certifying that the copy is accurate and is a complete copy of the original.
  4. 5. Controls must be established to ensure that all data that is generated is complete and accurate.
  5. 7. For paper records, Good Documentation Practices should be followed as outlined in SOP-0000003, Good Documentation Practices.
  6. 10. _________ Trail