Electronic Lab Notebook / Data Capture (if used for GMP) – Qualification Certificate Template

Qualification Certificate

Equipment Information

Equipment: Electronic Lab Notebook / Data Capture (if used for GMP)

Subcategory: NDDS – CSV / Data Integrity for NDDS

Area: System

Equipment Identifier: [Insert Equipment Identifier]

Qualification Flags

  • DQ: Critical – Yes
  • IQ: Critical – Yes
  • OQ: Critical – Yes
  • PQ: Critical – Yes

Requalification Information

Requalification Frequency: Yes

Next Due Date: [Insert Next Due Date]

Protocol References

Protocol Reference Numbers: [Insert Protocol Ref]

Execution Dates

Execution Dates: [Insert Execution Dates]

Calibration Status

Calibration Status: [Insert Calibration Status]

Deviations Summary

Deviations Summary: [Insert Deviations Summary]

Overall Qualification Statement

[Insert Overall Qualification Statement]

Approvals

Approved By: [Insert Approver Name]

Date of Approval: [Insert Approval Date]

See also  Colloid Mill (if used) – PQ Protocol