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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 qualif…
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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.
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AtmoCONTROL FDA Edition – IQ-OQ-Documentation
1. Introduction
The task of the FDA is the protection of public health in the US and the approval of pharma-
ceutical products. The FDA controls the safety and efficacy of medical products for human
and veterinary medicine, biological products, medical devices, food and radiation - emitting
devices, that arrive in the American market. This applies to products manufactured in the US
as well as imported products. FDA plays a significant role in addressing the Nation’s counter-
terrorism capability and ensuring the security of the food supply.
The Electronic Records and Signatures Rule, known as 21 CFR Part 11, were introduced by
the U.S. Food and Drug Administration (FDA) in order to define requirements for the use of
electronic documents instead of paper records. The law, published in the Federal Register on
March 20, 1997 and in effect since August 20, 1997, specifies the system elements, controls,
and procedures that are necessary to make sure the trustworthiness of electronically stored
records.
Conformity requires both procedural controls and administrative controls, such as Standard
Operating Procedures (SOPs), training and administration to be put in place by the user, in ad-
dition to the technical controls and elements that the system can offer. Therefore, no product
alone can fully meet the regulatory requirements. However, products with unified functions
that support 21 CFR Part 11 requirements can significantly ease the task of achieving and
maintaining full conformity with the law.
1.1 Purpose of Qualifi cation
Qualification of instruments or software is a formal process of documenting that an instru-
ment or software is fit for its intended use and that is kept maintained and calibrated.
IQ: The purpose of this qualification is to examine that the product designated as “examina-
tion object“ is complete and is essentially ready for operation.
It also documents that all important specifications and parameters described by the manufac-
turer, as well as its safety requirements, are fulfilled.
OQ: The purpose of this qualification is to ensure the function of the product designated as
“examination objects” and that it is ready for operation.
The following functions are tested:
► Security functions (according to FDA Titel 21 CFR Part 11)
► Control functions relevant for quality and/or process
2. Installation Qualifi cation
Installation Qualification (IQ) demonstrates that the AtmoCONTROL FDA software is properly
installed. Installation Qualification tests should be performed at the following times:
► When the system is installed
► Every time the software is upgraded
► Any time the associated computer is changed or modified
► Prior to running OQ tests