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CONDITIONS OF ACCESS AND USAGE

I am being granted access to Sartorius Self-Assessment Questionnaires or
Qualification Packages and related information. I understand that my access to
this Information is subject to the following conditions:

All information or documents provided by Sartorius to me shall be considered
bound to the purpose of my initial request to assess, qualify or audit Sartorius
as company and its sites and products (hereinafter the “Purpose”).

I am explicitly allowed to download, print, use and share this information for
the Purpose and in replacement of my own assessment documentation. For the
avoidance of doubt, any sharing of this documentation during an on-site or paper
audit is considered within the purpose of assessment documentation. For any
requests beyond the Purpose of my original request, I will not scan, copy, print
or otherwise distribute, share or spread any of the information provided to me
or contained on this site, neither partially nor in whole, and neither
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Furthermore I will not attempt to circumvent any of the security features of the
site, and will not enable or allow third parties to access this information
using my authorization to the site.

The information on this site has been prepared to assist interested parties in
making their own evaluation of the requirements given by Sartorius. I understand
that Sartorius is making no representations or warranties, express or implied,
as well as that Sartorius shall have no liability with respect to any use of the
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DEAR CUSTOMER

Sartorius is one of the world's leading providers of laboratory and process
technologies and equipment. Strongly rooted in the scientific and research
communities and closely allied with customers and technology partners, the
company is dedicated to its philosophy of "turning science into solutions" every
single day. Because of this, Sartorius strives to be proactive in providing its
customers with the most accurate and current information available regarding the
products and services provided.

Sartorius’ goal is to be among the industry leaders with respect to innovation
and quality.  Sartorius also understands and respects the needs of its customers
and how they play a role in the supply chain which leads to patient safety.
Because of these reasons, Sartorius has joined RX-360 and has been an active
member since 2009.

Rx-360 is a not for profit consortium led by volunteers from the Pharmaceutical
and Biotech industry including both manufacturers and suppliers.  The purpose is
to enhance the security and transparency of the pharmaceutical supply chain and
to assure the quality and authenticity of the products moving through the supply
chain. The organization's mission is to protect patient safety by sharing
information and developing processes related to the integrity of the healthcare
supply chain and the quality of materials within the supply chain.

Rx-360 has developed a tool for the Pharmaceutical and Biotech industries to
help companies asses the quality, regulatory and technical capabilities as well
as the supply chain sustainability of its strategic suppliers. This tool is
called the Supplier Assessment Questionnaire (SAQ).

THE SAQ was developed by the Supplier Led Committee of Rx-360 to standardize the
approach of requesting and presenting quality and technical information between
suppliers and their customers.  The SAQ was developed by a group made up of
global pharmaceutical, biotech companies and suppliers. It has been set up in
several parts to address required information regarding the supplier quality
system as well as the quality and technical questions of the specific products
and services provided.  The SAQ has been accepted and adopted by many of the
members of Rx-360 including some of the largest pharmaceutical and biotech
companies.

In an effort to better serve our customers and to provide information that
satisfies both global regulatory agencies and the current needs of the industry
and to be in alignment with the global leaders in pharmaceuticals and
biotechnology, Sartorius has adopted and implemented the Rx-360 Supplier
Assessment Questionnaire as the exclusive tool to respond to customer requests
for supply chain transparency, quality & technical information on the products
and services provided to its customers.

There will be several different SAQ’s completed representing the different
business units, product lines and services that Sartorius has in its portfolio.
The SAQ’s will be made available through a specially set up microsite for this
information.  Each SAQ will have a version number and the information will be
updated reviewed and updated annually and on an as needed basis.  The overall
program will be audited on top of the internal update program and on a periodic
basis as part of the Sartorius Global Corporate Audit program to ensure that the
information is current.

By adopting this globally recognized program, Sartorius will be able to present
the harmonized information that is necessary for end users to be able to meet
regulatory requirements and make quality decisions based on good science. It
will also allow for almost instantaneous access to the required information so
that both our customers and our operations personnel can concentrate on other
important operational matters.

If you have any questions regarding this program please contact:
Customer.Questionnaires(at)Sartorius.com 

Thank you for your interest in Sartorius.
Sincerely
Jan H. Lanfermann
Quality Coordinator
Quality Services


QUESTIONNAIRES


CC-CN STATEMENT FOR CUSTOMERS.PDF

PDF | 85.1 KB | July 02, 2021
Download


RX-360 SAQ - M1 - BPS LPS SARTORIUS AG.PDF

PDF | 161.7 KB | February 24, 2021
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