Qualification Plan

							                                  Quality Control Laboratory Equipment: Supplier Assessment



1 Purpose:
    The purpose of the QC Supplier Assessment is to determine if a prospective vendor has
    adequate Quality processes in place to ensure their ability to meet Genentech’s (GNE)
    specifications and quality standards in regards to equipment performance and reliability.

2 Scope:
    The Quality Control (QC) Supplier Assessment captures key contact information for prospective
    suppliers of QC analytical testing equipment which will be qualified per QS00089, Laboratory
    Equipment Qualification for Quality Control.


    Note:
    Multiple Supplier Assessments may be sent in conjunction with a single or multiple System
    Requirement Specification forms. Documentation supporting the alternative suppliers will be
    archived and the selected supplier’s assessment will be included with EQ packet.

    Each question of the Supplier Assessment targets a specific minimum expected requirement of
    quality systems or general quality of production. The process of answering each question first
    begins with an evaluation of Yes or No of the criteria asked. In the box below each Yes or No
    response is a more specific question asking for clarification on either a Yes or No response.

    If the supplier replies to a question in a manner that requires further clarification, there must be
    provided information as is appropriate. If there is not enough room in provided space on the
    form to complete the answer, it is appropriate to refer to an attachment. If an attachment is
    utilized, the original (preferred) or copy of the attachment must be initial and dated and included
    with the Supplier Assessment.

    The Supplier Assessment can be completed through phone, email or fax. Regardless of method,
    the conclusion must specify how the information was obtained and must include at a minimum a
    signed copy of the assessment by the Supplier Contact.
3 Equipment Information:
Equipment Description       This Yokogawa Chart Recorder Model DX2020 will be used to monitor temperature of
(describe the equipment)    controlled temperature environments/equipment for the Protein Analytical Chemistry Group.
                            These temperature signals will be sent out to the Facility Monitoring System (FMS) and
                            Environmental Monitoring System (EMS).


Family Risk Control Strategy #       QCRA0045             EQ Unique Identifier:         SSF-EIN# - 10010153

Supplier:    RM Controls Inc.                          Supplier Phone #:         805-499-4499

Supplier Contact Name:      George Yesowitch                Contact Title:       Salesperson



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                                         Quality Control Laboratory Equipment: Supplier Assessment


     4 Assessment Questionnaire:
                                                                                                           Pg. 1 of 2
Questions:                                                                                                YES NO
1. Are you an ISO 9000 certified manufacturer?
   If not, how do you retain production and quality control records for instrument manufacturing? Please explain:

2.   Do you have a documented change control system?
     If yes, please describe:

3.   Do you supply a certificate of compliance with each instrument?
     If yes, please describe information included:

4.   If your equipment is microprocessor based, but does not require an instrument controlling computer,
      is it 21 CFR Part 11 compliant?
     If yes, please describe:

5.   Do you provide equipment qualification protocols?
     If yes, please specify which protocols are offered and what intent of each are:

6.   Do you provide instrument warranties?
     If yes, please describe:

7.   Are customers notified of changes to instrument specifications or recommended configuration?
     If yes, please describe:

8.   Do other pharmaceutical companies have your instruments?
     If yes, Name(s):

9.   If required, would you support an audit of your manufacturing control system?
     If yes, Who would be the most appropriate contact?

10. Do you provide instrument repair service?
    I If yes, please describe process:

11. Do you have defined protocols for instrument repair?
    If yes, please describe:

12. Does the instrument come with a user manual?
    If yes, please list what supportive documents with a new instrument:

13. Do you provide user training?
    If yes, please describe offered training:




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Questions:                                                                                                     Pg. 2 of 2
 Computer based instruments:  N/A                                                                            YES NO
14. Is your software under version control?
    If Yes, please describe process:

15. Are users notified when changes have been made to the software?
    If yes, please describe process:

16. Is the root code user modifiable?
17. Can the user create custom macros?
18. Is your software considered 21 CFR Part 11 compliant?
    If yes, please explain:

19.   Is there access security through unique user profiles and passwords?
20.   Is there an audit trail for actions performed during software operation?
21.   Does the software automatically save generated data?
22.   If the software automatically saves generated data, can this option be disabled?
      If yes, please explain:

23. Does the computer based instrument have network connectivity ability?
    If yes, please describe:

24. Do you require vendor provided or purchased computers to be used with your instrument?
    If yes, please explain:

25. Is there training available or required by the user?
    If yes, please explain:


      5 Conclusion:
Vendor Interview through                Phone       Mail      Other: (Specify)

Supplier Contact Signature:
                                                                       (Sign/Date)
Supplier Determination:              Supplier is Acceptable       Supplier is Not Acceptable        See Attachment(s)

Completed by

                        Print Name                    Signature                            Date
Department:


Quality
Approval:
                        Print Name                    Signature                            Date
Department:




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