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Manufacturer and customer service Memmert GmbH + Co. KG Willi-Memmert-Straße 90–96 D-91186 Büchenbach Deutschland/Germany Phone: +49 (0)9122 925-0 Fax: +49 (0)9122 14585 E-mail: sales@memmert.com Internet: www .memmert.c…
AtmoCONTROL
www.memmert.com
MADE IN GERMANY.
FDA EDITION
IQ DOCUMENTATION
OQ DOCUMENTATION
Manufacturer and customer service
Memmert GmbH + Co. KG
Willi-Memmert-Straße 90–96
D-91186 Büchenbach
Deutschland/Germany
Phone: +49 (0)9122 925-0
Fax: +49 (0)9122 14585
E-mail: sales@memmert.com
Internet: www.memmert.com
Customer service:
Service hotline: +49 (0)9171 9792 911
Service fax: +49 (0)9171 9792 979
E-mail: service@memmert.com
© 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