JETT Document Status Tracking Worksheet

URS Documents Tracking Worksheet

Current Website
# URS Template Name JETT Sponsor/Owner Status/Remarks
Revision Status

Barrier Isolator & HVAC

1. Petro 0 0 Updated on website 12/2002
System
Not Bob Brokamp of Jacobs will be the new point man for this URS. Sent email on
2. BioReactors Fisk A1
Loaded 10/17/03, to verify commitment. No response yet.
Building Management Format review completed 9/17/03 and returned to Roerig for final review before
3. Roerig, Regan 0 B1
System release. Returned for final format review and initial release on 9/19/03.
Per September 2003 meeting, LeDoux with have it reviewed by somebody to get it to
4. Centrifuge Lustri, Roerig A2 A2
the next step in the process.
5. Chromatography LeDoux 0 0 Released and available on website as of May 14, 2002.

Reviewed during September 2003 meeting, and led by John Dexter. Reviewed by
Not Roerig, Lauderman, LeDoux,
6. CIP Systems Lauderman A3
Loaded

Not
7. Depyrogenation Tunnel Petro 0 Approved for initial release on 9/16/03
Loaded
8. Blender Miller 0 B1 Approved for initial, formal release by Vince Miller on July 27, 2003
9. Batch Fluid Bed Dryer Miller 0 C5 Approved for initial release on 9/16/03

Current Website
# URS Template Name JETT Sponsor/Owner Status/Remarks
Revision Status

Not During September 2003 meeting, Roerig took over the sponsorship and will move it
10. Freeze Dryer Roerig A9
loaded along.
Bret has taken one last shot at review following format review. Marieva has made
11. Glassware Washers Fisk 0 C1
corrections per Bret. Released on 4/17/03
SaturatedReleased
Steam Validation Review Format Review Action Required
12. Noteboom 0 0 Released and available on website as of August 19, 2002.
Autoclaves (GMP)

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 JETT Document Status Tracking Worksheet
Current Website
# URS Template Name JETT Sponsor/Owner Status/Remarks
Revision Status

Reviewed during September 2003 meeting and resolved all issues that arose during
Not content review. Comments were incorporated on 9/19/03 and passed on to Marieva
13. Granulators Miller A2
Loaded to clean up some formatting issues prior to sending to Casey for validation review.
Sent to Casey on 9/30/03.

14. Label Re-winder Coury 0 0 Released and available on website as of May 14, 2002.
15. Labeler Coury 0 0 Released and available on website as of July 11, 2002.
Mike Casey gave approval to release as rev 0 on 2/7/03. Format review performed o
16. Multiple-Effect Still Casey 0 C1
04/17/03.
17. Pure Steam Generator Casey 1 1 Released and available on website as of May 17, 2002.
Reviewed during September 2003 meeting and resolved validation comments. It was
18. Tablet Coater Miller C4 C4
passed on for format review on 9/19/03.
Not in Not During August 2003 meeting, transferred sponsorship to Paul Coury to get URS moving
19. Tablet Press Paul Coury
Archive Loaded again.

URS Documents (cont.)

Released Validation Review Format Review Action Required

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 JETT Document Status Tracking Worksheet
URS Documents (cont.)

Current Website
# URS Template Name JETT Sponsor/Owner Status/Remarks
Revision Status

Second Development Pass on Template Underway. Filary sent latest version to

Variable Data Inspection Regan in September for review and further development. No progress to report.
20. Regan A2 002
(Inspection Systems)
Sent email requesting update on 9/12/03. No progress to report.
21. Vial Washer Petro 0 0 Updated on website 12/2002.
Reviewed during August meeting by Mike Filary and Ramond LeDoux for format and
22. Purified Water LeDoux B1 B1
content. Mike will have completed to release by October meeting.
Validation review completed (Petro email 7/16/02). Document on website appears
23. Wide-Range Filler Petro C1 B1
different than archive. Format review in progress (may be on wrong document)
Tangential Flow Filtration Not
24. LeDoux 0 Approved for initial, formal release by Ramon LeDoux on August 22, 2003.
(TFF) System Loaded
Reviewed by Paul Coury, John Liebenthal, Chris Roerig and Steve Smith at the last
Not in Not
25. SCADA Systems Roerig JETT meeting. Steve Smith is incorporating changes from review and will be ready for
Archive Loaded
content review.
Reviewed during August’s meeting by Marieva. Glen Barber sent pdf file. Requested
Not
26. Cappers Rivera B1 MS Word file from Glen on 9/12/03. Sent to Mike Casey for Validation Review on
Loaded
9/15/03.
Not Reviewed during September 2003 meeting. John Liebenthal will pass comments on
27. Vial Tray Loader Petro A2
Loaded to Petro.

Released Validation Review Format Review Action Required

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 JETT Document Status Tracking Worksheet
Inactive Documents
Current Website
# URS Template Name JETT Sponsor/Owner Status/Remarks
Revision Status

Not in Not
28. Packaging Equipment Mell Bahl Transferred sponsorship to Mell Bahl during September 2003 meeting.
Archive Loaded
Not in Not
29. Cottoner Merieva Marieva will sponsor per Jan2003 meeting
Archive Loaded
Not in Not
30. Form/Fill/Seal LeDoux Transferred sponsorship to LeDoux during August 2003 meeting.
Archive Loaded
Not in Not Transferred sponsorship to Coury during August 2003 meeting and moved to active
31. Tablet Press Paul Coury
Archive Loaded section

Released Validation Review Format Review Action Required

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 JETT Document Status Tracking Worksheet

Misc. Documents
Current Website
# Document Name JETT Sponsor/Owner Status/Remarks
Revision Status

32. Equipment Validation Plan Filary 0 0 November 2002 meeting – It was decided to release document as rev 0
Updated 9/16/03 by Marieva Rivera for: removed automatic style update, replaced
33. URS Template Filary 2 1
bullets with outline #’s. Review updates at September meeting
Functional Specification Not Reviewed during November meeting by Coury, Filary, Lauderman, Joe Dougherty, IPR
34. Filary A1
template Loaded Filary will incorporate comments
Example Pure Steam
Generator sample Original sample created in June 1997 is posted on website. Latest rev was converted
35. Filary B 1
Hardware Design to new format in May 2001
Specification (HDS)
Example Pure Steam
36. Generator sample Factory Filary 1 1 Original sample created in June 1997
Acceptance Test (FAT)
37. Document Control Filary 4 4 Updated on website 12/02
Example Pure Steam
38. Generator sample Filary 1 1 Original sample created in June 1997
Functional Specification
Example Pure Steam
Original sample created in June 1997 is posted on website. Latest rev was converted
39. Generator sample Software Filary B 1
to new format in May 2001
Design Specification (SDS)
Not
40. 21 CFR Part 11 Lustri A1 Reviewed initial draft at Jan 2003 meeting. Jonathan will continue his approach.
Loaded

Released Validation Review Format Review Action Required

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 JETT Document Status Tracking Worksheet
Misc. Documents (cont.)

Current Website
# Document Name JETT Sponsor/Owner Status/Remarks
Revision Status

Not in Not
41. FAT/SAT Template Rosendale Jeff O’Donel will draft per Jan 2003 meeting
Archive Loaded
FAT Example (Packaging Not in Not
42. Mel Bahl Mel is developing based on template used by his company.
Machines) Archive Loaded
Example Wide Range
43. Petro A6 A6 Added to website 8/3/03
Filler FS
Example Wide Range
44. Petro A1 A1 Added to website 8/3/03
Filler DS
Example Wide Range
45. Petro A2 A2 Added to website 8/3/03
Filler RTM
Example Wide Range
46. Petro ? ? Added to website 8/3/03
Filler APP
Example Wide Range
47. Petro A2 A2 Added to website 8/3/03
Filler URS

Released Validation Review Format Review Action Required

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