DocuSign Envelope ID: 7462036B-8639-4327-B60F-4265710540CCConfirmation of Complianceof Multiwave 5000 software 2.0
with the U.S. Food and Drug Administration regulation Part 11 of Title 21 of the Code of FederalRegulations

Multiwave 5000

1 Audit Target
In May 2024, Anton Paar GmbH has audited the software Multiwave 5000 version 2.0, used for theoperation of Multiwave 5000 in respect of Part 11 of Title 21 of the Code of Federal Regulations.

2 Certification of compliance
Anton Paar GmbH hereby confirms that the above-mentioned software contains all technicalcontrols for compliance with Part 11 of Title 21 of the Code of Federal Regulations. This
regulation requires computerized systems to include technical controls to assure thatelectronic records maintain security and integrity and are as verifiable as paper records;
and

electronic signatures meet standards that allow them to have the same legal bearing as
traditional handwritten signatures.

Overall compliance with Part 11 of Title 21 of the Code of Federal Regulations can only be met
together with the operational environment. Therefore, it is the responsibility of the operator tocorrectly and consistently implement the procedural and administrative controls (such as technicalenvironment, data management, notifications, administration, training, standard operatingprocedures) and to use the product with the correct technical controls.
Given that the operator responsibilities concerning the procedural and administrative controls aremet, the Multiwave 5000 software is compliant with Part 11 of Title 21 of the Code of Federal
Regulations and is well-suited for the implementation in controlling the instrument.

3 Basis for certification
The above certification is based on the following audit results:
I.

The Multiwave 5000 software version 2.0 contains the technical controls for limitation of andauthorization for the system by user verification through the usage of passwords, therefore
assuring electronic record integrity. The User identification code and password are required
during electronic signature executions.

II.

All technical controls providing limitation and authorization require the operator to use thecorrect technical controls and to correctly and consistently implement the corresponding
procedural and administrative controls such as technical environment, data management,notifications, administration, training, Standard Operating Procedures. The software canonly provide a technical base for limitation and authorization only effective if and to theextent such controls are implemented.

III.

Permission to access or modify tasks can be permitted by an administrator and users areindividually identified to track who has created, modified or signed an electronic record so
there is a clear link between an electronic signature and the data file including signer, date,www.anton-paar.com

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DocuSign Envelope ID: 7462036B-8639-4327-B60F-4265710540CC

Confirmation of Compliancetime and meaning and non-repudiation is guaranteed. Any changes made after theelectronic signature is executed can be detected.
IV.

Users are only allowed to create, edit and delete contents according to the security and/orpermission level they have been granted via user role on a role-based security model.

V.

User actions and workflow events are recorded by a secure, computer-generated audit trail
protecting the contents, identifying the details of the changes made and guaranteeing thepossibility to reconstruct the content prior to changes. Workflows must be executed in thepermitted sequence.

VI.

Unauthorized password use is reported and accounts are disabled upon multiple
unsuccessful attempts to log in. The User Identification codes are unique – no two user
accounts can have the same code – and therefore, the electronic signature is as well.

This is confirmed on behalf of Anton Paar GmbH by its authorized representative.

Johannes Gradwohl
Head of Product line
Analytical & Synthetic Chemistrywww.anton-paar.com

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