DOCUMENT OVERVIEW
What this Good Documentation Practices SOP covers
Prepared by PharmaEdges
Good Documentation Practices support records that clearly show what happened, when it happened and who performed the activity. This template addresses entries made at the time of work, signatures and dates, blank fields, record legibility and corrections that preserve the original information.
It also covers transcribed, lost or damaged records and the handling of documentation incidents and errata. The supporting records capture incident details, assessment, investigation, corrective actions and closure. The site must define escalation and approval rules appropriate to the significance of the event.
Practical examples of Good Documentation Practices
These examples explain the scope of the template. Apply the reviewed and approved site procedure in actual work.
1. Record the activity when it happens+
Enter observations directly in the authorized record at the time of the activity. Identify the person making the entry and the date where required. Complete applicable fields and handle unused spaces according to the approved instructions.
2. Correct an entry without hiding the original+
Illustrative example: if a temperature was written as 40.7 °C but the verified observation was 40.9 °C, keep the original entry readable with a single strike-through, enter the correct value and add the required signature, date and reason. Obtain any required verification. Never replace a genuine result merely because another value is preferred.
3. Assess a documentation incident+
For a lost, damaged or otherwise affected record, follow the site assessment route. The document incident form supports documenting the event, impact assessment, investigation, corrective actions and closure; the incident log tracks the case. Do not discard original evidence to make the record appear complete.
4. Use errata through the approved process+
Use the errata form and log for corrections that the site procedure permits through that route. Assess the nature and impact of the issue before choosing a route. An errata record is not a substitute for an investigation or deviation process when one is required.
What is included in this SOP package
Document Incident Form+
Records the incident, QA assessment, investigation, possible or root cause, corrective and preventive actions, attachments and closure.
Document Incident Log Book+
Tracks the incident reference, affected document, description, issue details and closure.
Errata Log Book+
Maintains traceability of errata records using the approved site numbering and control process.
Errata Form+
Documents an errata correction through the site-approved review and authorization route.