stamping stamping Document Revision

stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping N: ADAM-RU55311 N: 214.2 Effective Date:

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

Document Status: Under approval

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 2 to 8 9 to 15 16 to 25 26 to 50 51 to 90 91 to 150 151 to 280

No. of documents to check post migration 2 2 3 5 5 8 15

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stamping stamping Document Revision

stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping N: ADAM-RU55311 N: 214.2 Effective Date:

281 to 500 501 to 1200 1201 to 3200 3201 to 10000

20 32 50 80

Document Status: Under approval

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 retesting 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.

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stamping stamping Document Revision

stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping N: ADAM-RU55311 N: 214.2 Effective Date:

Post-Loading Activity Table

Step
1.

Procedure Description
No. of Documents to Verify (See step 2 of test strategy) Set PC time settings to GMT 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 Right-click on the document again and select Properties Document the types of documents (e.g. Corporate Global & Regional Americas) checked on Appendix 1, Verification of data. Verify the following information for each document and repeat for entire sampling set. Document findings on Appendix 1, Verification of data.

Enter Required Information

Initial / Date

Document Status: Under approval

2.

3.

4. 5.

See Appendix 1, Verification of data for testing documentation.

6.

MERLIN Properties tab fields Reference # Version Number Distribution Date

PDF Document Stamping Pagination Document number Revision Effective Date

Acceptance Criteria All Pages are numbered correctly, Page X of Y Entry Matches Entry Matches Entry Matches

7. 8.

Set PC time settings to back to local PC time. 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

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stamping stamping Document Revision

stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping N: ADAM-RU55311 N: 214.2 Effective Date:

APPENDIX 1: Verification of Data Document Type Loaded:___________________________

Sampling Number Sterigenics Reference Number WI-005-EHS-EM WI-003-ADM-EM 00-ISP-OP-PRO-002 00-ISP-OP-PRO-001 WI-005-QAI-EM WI-014-EHS-EM-EO WI-008-EHS-EM WI-005-ADM-EM 00-ISP-QA-DEF-002 WI-003-QAI-EM WI-009-QAI-EM 00-ISP-QA-DEF-001 WI-004-EHS-EM-EO WI-003-EHS-EM-EO 00-ISP-OP-PRO-004 WI-011-EHS-EM-EO WI-007-EHS-EM WI-011-ADM-EM WI-002-EHS-EM-EO 00-ISP-OP-PRO-005 00-ISP-OP-VAL-001 WI-010-EHS-EM 00-ISP-MA-TRN-001 WI-006-ADM-EM WI-007-ADM-EM Pagination Correct Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Document Number Correct Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Revision Correct Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Effective Date Correct Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Actual Result Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout

1. 2. 3.

Document Status: Under approval

4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25.

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

Performed By:

Date:

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stamping stamping Document Revision

stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping N: ADAM-RU55311 N: 214.2 Effective Date:

APPENDIX 1: Verification of Data Document Type Loaded:___________________________

Sampling Number Sterigenics Reference Number WI-202-EHS-EM WI-009-EHS-EM WI-008-ADM-EM WI-008-QAI-EM WI-001-EHS-EM-EO WI-010-ADM-EM 00-ISP-OP-PRO-003 Pagination Correct Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Document Number Correct Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Revision Correct Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Effective Date Correct Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Actual Result Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout Attached Printout

26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. 50.

Document Status: Under approval

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

Performed By:

Date:

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stamping stamping Document Revision

stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping stamping N: ADAM-RU55311 N: 214.2 Effective Date:

Reviewers: Approvers:

Document Status: Under approval

Russell, Adam

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