_adam-ru55311_ stamping stamping stamping stamping stamping stamping stamping stamping stamping...

8/2/2019 _ADAM-RU55311_ Stamping Stamping Stamping Stamping Stamping Stamping Stamping Stamping Stamping Stam

1/6

1. sfdsfdsfdsfdsfsdfsdf level I, and AQL of 0.065. The Lot is considered to be one document.

2. According to the sampling plan, the table below summarizes the amount of documents that

need to be verified based on the amount of documents migrated for the facility. Consult the

table below and determine the number of documents to be checked post migration and

document this in the Post-Loading Activity table.

No. of documents uploaded No. of documents to check post migration2 to 8 2

9 to 15 2

16 to 25 3

26 to 50 5

51 to 90 5

91 to 150 8

151 to 280 15

Confidential Information

The user is responsible for ensuring that the appropriate version of the document is obtained for the intended use.

stamping stamping stamping stamping stamping stamping stampingstamping stamping stamping stamping stamping stamping stampingDocument N: ADAM-RU55311Revision N: 214.2 Effective Date:

Page 1 of 6

DmeSauU

ao


2/6

281 to 500 20

501 to 1200 32

1201 to 3200 50

3201 to 10000 80

3. Follow instructions on the Post-Migration Activity Table.4. Document verification findings in Appendix 1.

5. If data does not match for any field in any document the migration will be considered a failure.

a. Document the failure in a test incident report form SVM004F. Perform the appropriate

investigation and document the resolution. All test incidents must be resolved and re-

testing performed successfully (if necessary) prior to acceptance of the data migration

activity.

6. Document the response for the overall acceptance criteria on the Post-Migration Activity Table.

7. Forward all documentation to Software Validation Manager for Review.




Page 2 of 6

DmeSauU

ao


3/6

Post-Loading Activity Table

Step Procedure Description Enter Required Information Initial / Date

1. No. of Documents to Verify (See step 2 of test strategy)

2. Set PC time settings to GMT

3.

Log into MERLIN and randomly select a document from the document structure and

right click and select View Distributed Version. Print the first page of the document

and retain with testing documentation.

Note: Check only documents that have native formats other than PDF as these are the

documents that are converted. Try to include a mixture of documents in your

selection such as templates, forms, work instructions, quality system procedures, etc

4. Right-click on the document again and select Properties

5.Document the types of documents (e.g. Corporate Global & Regional Americas)

checked on Appendix 1, Verification of data.

6.

Verify the following information for each document and repeat for entire sampling set.

Document findings on Appendix 1, Verification of data.

MERLIN Properties

tab fields

PDF Document

StampingAcceptance Criteria

Pagination All Pages are numbered

correctly, Page X of Y

Reference # Document number Entry Matches

Version Number Revision Entry Matches

Distribution Date Effective Date Entry Matches

See Appendix 1, Verification of data

for testing documentation.

7. Set PC time settings to back to local PC time.

8.

Overall Acceptance Criteria: All PDF documents have correct information for

pagination, document number, revision number, and effective date for documents

checked.

Yes / No (Circle One)

Reviewed By / Date

Confidential InformationThe user is responsible for ensuring that the appropriate version of the document is obtained for the intended use.


Page 3 of 6


4/6

APPENDIX 1: Verification of Data

Document Type Loaded:___________________________

Sampling

Number

Sterigenics

Reference Number

Pagination

Correct

Document

Number Correct

Revision

Correct

Effective Date

Correct

Actual Result

1. WI-005-EHS-EM Yes / No Yes / No Yes / No Yes / No Attached Printout

2. WI-003-ADM-EM Yes / No Yes / No Yes / No Yes / No Attached Printout

3. 00-ISP-OP-PRO-002 Yes / No Yes / No Yes / No Yes / No Attached Printout


5. WI-005-QAI-EM Yes / No Yes / No Yes / No Yes / No Attached Printout

6. WI-014-EHS-EM-EO Yes / No Yes / No Yes / No Yes / No Attached Printout



9. 00-ISP-QA-DEF-002 Yes / No Yes / No Yes / No Yes / No Attached Printout



12. 00-ISP-QA-DEF-001 Yes / No Yes / No Yes / No Yes / No Attached Printout









21. 00-ISP-OP-VAL-001 Yes / No Yes / No Yes / No Yes / No Attached Printout


23. 00-ISP-MA-TRN-001 Yes / No Yes / No Yes / No Yes / No Attached Printout



*If No reference TIR # next to sampling number in which the test incident occurred.

Performed By: Date:




Page 4 of 6

DmeSauU

ao


5/6

APPENDIX 1: Verification of Data

Document Type Loaded:___________________________

Sampling

Number

Sterigenics

Reference Number

Pagination

Correct

Document

Number Correct

Revision

Correct

Effective Date

CorrectActual Result








33. Yes / No Yes / No Yes / No Yes / No Attached Printout


















*If No reference TIR # next to sampling number in which the test incident occurred.

Performed By: Date:




Page 5 of 6

DmeSauU

ao


6/6

Reviewers:

Approvers:

Russell, Adam




Page 6 of 6

DmeSauU

ao