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D39051 | Date 12/2019 | v2.9 3 AtmoCONTROL FDA Edition – IQ-OQ-Documentation Contents 1. Introduction 5 1.1 Purpose of Qualification .......................................................................................…
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© 2019 MEMMERT GmbH + Co. KG
D39051 | Date 12/2019 | v2.9
We reserve the right to make changes
D39051 | Date 12/2019 | v2.9 3
AtmoCONTROL FDA Edition – IQ-OQ-Documentation
Contents
1. Introduction 5
1.1 Purpose of Qualification ...................................................................................................... 5
2. Installation Qualifi cation 5
2.1 Packing List Verification ....................................................................................................... 6
2.2 Software Installation (to be completed by user) ................................................................. 6
2.3 Assessment of Installation Qualification ............................................................................. 7
3. Operational Qualifi cation 8
3.1 Login .................................................................................................................................... 8
3.2 Admin and User Rights ........................................................................................................ 9
User Rights ......................................................................................................................... 11
Audit Trail ........................................................................................................................... 12
3.3 Connect database .............................................................................................................. 13
3.4 Signatures ..........................................................................................................................14
Security .............................................................................................................................. 17
3.5 Editor ................................................................................................................................. 18
Signatures .......................................................................................................................... 20
3.6 Export ................................................................................................................................ 21
3.7 Backup ............................................................................................................................... 24
3.8 Help.................................................................................................................................... 25
3.9 Assessment of Operational Qualification .......................................................................... 26
4 D39051 | Date 12/2019 | v2.9
AtmoCONTROL FDA Edition – IQ-OQ-Documentation
Please follow the instructions below and fill out each gap in order to perform the installation
qualification as well as the operational qualification.
Examination object (to be completed by user)
Manufacturer: MEMMERT GmbH + Co.KG, 91126 Schwabach, Germany
Designation: Memmert AtmoCONTROL FDA
Version:
Site:
Occasion:
Inspection Personnel (to be completed by user)
Name Position Signature Date
Performed by:
Approved by:
Memmert recommends that the IQ/OQ protocols are performed in total when AtmoCONTROL
FDA is initially installed. Installation Qualification should be performed as well when the
software is upgraded and when the computer that runs AtmoCONTROL FDA is changed or
modified. Operational qualification should also be run on a regular basis to confirm that the
system is performing to specification and also when there is any doubt that the instrument is
not performing to specifications.