19.11.2013 |

LOGFILE No. 25/2012 - Typical GMP Audit Questions

10 typical GMP audit questions about electronic records

 

Typical audit questions

Assessment

Notes

CFR reference

EU GMP Guideline

yes/met

partly met/ accepted

partly met/
not accepted

no

Closed systems

Validation of documentation systems

1. Has the system been validated to ensure accuracy, reliability and the consistent intended performance of the system?

          §11.10 (a)  
2. Is it possible to ensure by validation that invalid or altered electronical records are  discerned?           §11.10 (a) Annex 11: 17
Retrieval during the records retention period
3. Does the system allow for the ready retrieval of electronic records throughout the records retention period?           §11.10 (c)  
Operational system checks
4. Have operational system checks been used to check the permitted sequencing of steps and events?           §11.10 (f )  
Device checks
5. Have devices been checked to determine the validity of data input?           §11.10 (h) Annex 11: 6
Training
6. Do persons who develop, maintain or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks?           §11.10 (i) Annex 11: 2
Written policies
7. Do written policies exist that establish responsibilities for electronically signed records?           §11.10 (j) Annex 11: 2
System documentation
8. Do procedures for the distribution of, access to, and use of documentation for system  operation and maintenance exist?           §11.10 (k) Annex 11: 3.3
9. Are there any change control procedures for the modification of systems documentation?           §11.10 (k) Annex 11: 10

Open systems

10. The requirements for closed systems as described in §11.10 also apply to open systems. Furthermore open systems should include additional measures such as document encryption systems.           §11.30  
LOGFILE-25-2012-Electronic-Records-Audit-Questions.pdf

These 10 questions are an extract from the "Checklist GMP-Inspections" by Maas & Peither GMP Publishing. 

This questionnaire contains 650 questions typically asked during GMP inspections, arranged by subject-matter. The information sources include the 21 CFR 210/211/11 and the EU-GMP-Guide Parts I and II.

>>>More information: Checklist GMP-Inspections

 
 
 

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