commitments database prototype 2b issues & suggested changes log with osman's estimates
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Issue ID Completed? 12/9 Decision 12/9 Notes Type Of Issue
18 Harmonization Medium Priority
23 Accept New Req
Priority ofIssue
Sparta FollowUp
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Priority Rank Questions for Sparta Sparta Comments
4 Later During Re-key Harmonization
Later New request.
ImpelmentationPhase
Estimated Time -hrs(Sparta)
If the "Date Opened" field isremoved later after we go to
PROD. Could the field beremoved from recordsalready created? Whatwould be the level of effort ifthe fields could be removed-i.e. each individual recordselected or system caneasily remove field from allrecords?
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Issue Record Type Field Name Reported By
Date Opened Bethany
Inspection Inspected Site Zeon
Remove field "Date Opened" fromall record types. Harmonizationeffort
Inspection, Observation,Gap Remediation,Action, Gap Assessment,Recommendation,RecommendationAction(s),Commitment,Follow Up
Remove "Biologics Corporate,""Small Molecules Corporate," and"Global" selection values
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Criticality Comments Assigned ToReproducibleSequence
Relevant (TW)Record IDs
ProposedResolution
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Completed On Approved ByActualResolution Items that will
Require Training
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Field Record Field Type
Inspected SiteInspection Single Selection
Inspection Type Inspection Single Selection
Health Authority Inspection Single Selection
OU & BU Inspected Inspection Multi Selection
Product(s) in Scope Inspection Multi Selection
Observation Classification Observation Single Selection
Theme(s) Observation, Recommendation Multi Selection
Assessment Records Needed? Observation, Commitment, Recommendation Action(s)Single Selection
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Sites Potentially Impacted Observation, Commitment, Recommendation Action(s)Multi Selection
Action to be Taken? Recommendation Single Selection
Date Explicitly Committed To? Commitment Single Selection
Most Recent Status Update? Commitment, Follow Up, Gap Remediation, Recomme Single Selection
Potential Miss/Overdue? Commitment, Follow Up, Gap Remediation, Recomme Single Selection
Inspected Site? Gap Assessment, Gap Remediation Single Selection
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Site / Group Gap Assessment, Gap Remediation, Action Single Selection
Gaps? Gap Assessment, Action Single Selection
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Values Comments
ManufacturingKarachi
P: Paper-basedInspection (noinspector physically
on-site)
Netherlands - IGZ /CBG-MEB
If "Other" is selected then we will need thefield "Other Health Authority" required
Small Molecules DrugSubstanceSmall Molecules Dru
List reads from SAP, same values as thefield "Impacted Product" in the CAPA system
CriticalMajorMinorOtherN/A
Adverse Events
Analytical MethodsCalibrationCleaningElectronic IssuesEMEquipment/FacilitiesFailure InvestigationsMedia FillsMonitoringRaw MaterialsRecord KeepingSpecificationsStabilityTrainingValidationVendors
YesNo
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ClarecastleFlorenceGlobalHillsboroIsandoKaiseraugst -
Packinging andSupplyKaiseraugst -ParenteralsKaiseraugst -RocephinManufacturingLeganesMannheim BiologicsMannheim SmallMoleculesNutleyOceanside
PenzbergRio de JaneiroSegrateShanghaiSmall MoleculesCorporateSingapore
YesNo
YesNo
Yes
NoYesNo
YesNo
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ClarecastleFlorenceGlobalHillsboroIsandoKaiseraugst -
Packinging andSupplyKaiseraugst -ParenteralsKaiseraugst -RocephinManufacturingLeganesMannheim BiologicsMannheim SmallMoleculesNutleyOceanside
PenzbergRio de JaneiroSegrateShanghaiSmall MoleculesCorporateSingapore
YesNo
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Evaluate where blue text could make things more intuitive
Need to flush out the Status Update Process.
Gap Assessment & Remediation from a Commitment
Recommendation Record and Recommendation Actions
What states need to move backwards?
Status Update
Recent Update (Y/N)
(2) Potential to Miss or Overdue (Y/N)
Status Update [if (2) is Y]
Project Due Date [if (2) is Y]
some text to tell them how to proceed to the next step.
assessment is needed.
logistics.
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Field Type
TAB: Observation
SECTION: Record Details
Initiator Person
Date Opened Date/Time
IM / Quality Coordinator Person
(Parent) Inspection Title Virtual String
(Parent) Inspection Start Date Virtual Date
(Parent) Inspection End Date Virtual Date
SECTION: Observation Details
Observation # String
Observation Classification Single Selection
Assessment Records Needed? Single Selection
Observation Text Flexfield
Defended Subpart String
Theme(s) Multi Selection
Repeat Observation? Single Selection
Attachments File Attachment
SECTION: Observation Results
Evaluation Flexfield
Response Flexfield
TAB: Impact
SECTION: Impact
Assessment Impact Multi Selection
TAB: Parent / Root Parent Info
(Parent) Inspected Site Virtual Selection(Parent) Operational & Business Unit(s) Virtual Multi Selecti
(Parent) Health Authority Virtual Single Sele
(Parent) Inspection Start Date Virtual Date
(Parent) Other Health Authority Virtual String
(Parent) Inspection End Date Virtual Date
(Parent) Inspection Title Virtual String
(Parent) Inspection Type Single Selection
(Parent) Product(s) in Scope Multi Text
(Parent) Investigator(s) Multi Text
(Parent) Other Health Authority String
SECTION: Parent / Root Parent
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Comments
C
C
R
R
N
C
on
tion
N
N
N
N
Field status based on Prototype 1a/1b
feedback?R = Remove Field
N = New FieldC = Change Field Name (see column
New Field Name)
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New Field Name
Obs./Rec. #
Defended Supart(s)
Sites Potentially Impacted
YY
Y
Y
Y
Y
Y
Y
Y
Y
Y
Change Field Type? "Y" (blank = "N")
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New Field Type
Copied SelectionCopied Multi Selection
Copied Single Selection
Copied Date
Copied String
Copied Date
Copied String
Copied Single Selection
Copied Multi Text
Copied Multi Text
Copied String
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Field Type
TAB: Recommendation
SECTION: Record Details
Initiator Person
Date Opened Date/Time
IM / Quality Coordinator Person
(Parent) Inspection Title Virtual String
(Parent) Inspection Start Date Virtual Date
(Parent) Inspection End Date Virtual Date
SECTION: Recommendation Details
Recommendation # String
Recommendation Text Flexfield
Recommendation Impact Multi Selection
Theme(s) Multi Selection
SECTION: Recommendation Results
Evaluation Flexfield
Action to be Taken? Single Selection
Attachment File Attachment
TAB: Parent / Root Parent Info
(Parent) Inspected Site Virtual Selection
(Parent) Operational & Business Unit(s) Virtual Multi Selecti
(Parent) Health Authority Virtual Single Sele
(Parent) Inspection Start Date Virtual Date
(Parent) Other Health Authority Virtual String
(Parent) Inspection End Date Virtual Date
(Parent) Inspection Title Virtual String(Parent) Inspection Type Single Selection
(Parent) Product(s) in Scope Multi Text
(Parent) Investigator(s) Multi Text
(Parent) Other Health Authority String
SECTION: Parent / Root Parent
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Comments
C
R
on
tion
N
N
N
N
Field status based on Prototype 1a/1b
feedback?R = Remove Field
N = New FieldC = Change Field Name (see column
New Field Name)
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New Field Name
Obs./Rec. #
Y
Y
Y
Y
Y
Y
YY
Y
Y
Y
Change Field Type? "Y" (blank = "N")
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New Field Type
Copied Selection
Copied Multi Selection
Copied Single Selection
Copied Date
Copied String
Copied Date
Copied StringCopied Single Selection
Copied Multi Text
Copied Multi Text
Copied String
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Field Type
TAB: Commitment
SECTION: Record Details
Initiator PersonDate Opened Date/Time
Assigned To Person
IM / Quality Coordinator Person
(Root Parent) Inspection Title Virtual String
(Root Parent) Inspection Start Date Virtual Date
(Root Parent) Inspection End Date Virtual Date
SECTION: Commitment Detail
Observation Subpart(s) String
Assessment Records Needed? Single Selection
Commitment FlexfieldDue Date Date
Commitment Due Date Date
Date Explicitly Committed To? Single Selection
Associated Record #'s Reference Record
SECTION: Action Plan
Action Plan Flexfield
Evidence for Closure Flexfield
Action Plan Attachments File Attachment
SECTION: Updates
Projected Completion Date DateMost recent status update?
Potential miss/overdue?
Status Single Selection
Updates Flexfield
SECTION: Closure Summary
Commitment Actions Summary Flexfield
Attachments File Attachment
TAB: Impact
SECTION: Impact
Assessment Impact Multi SelectionTAB: Parent / Root Parent Info
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(Parent) Observation Text Virtual Flexfield
(Parent) Recommendation Text Virtual Flexfield
(Parent) Evaluation Virtual Flexfield
(Root Parent) Inspected Site Virtual Single Sele
(Root Parent) Health Authority Virtual Single Sele
(Root Parent) Other Health Authority Virtual String
(Root Parent) Inspction Start Date Virtual Date
(Root Parent) Inspection Title Virtual String
(Root Parent) Inspection End Date Virtual Date
(Parent) Response Virtual Flexfield
(Root Parent) Inspection Type Single Selection
(Root Parent) Product(s) in Scope Multi Text
(Root Parent) Investigator(s) Multi Text
(Root Parent) Other Health Authority String
(Parent) Obs./Rec. # Virtual String
SECTION: Parent / Root Parent
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Comments
N
C
RN
N
C
Field status based on Prototype 1a/1bfeedback?R = Remove Field
N = New FieldC = Change Field Name (see column
New Field Name)
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R
tion
tion
N
N
N
N
N
N
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New Field Name
Associated Record(s)
Sites Potentially Impacted
Change Field Type? "Y" (blank = "N")
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Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
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New Field Type
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Copied Single Selection
Copied Single Selection
Copied String
Copied Date
Copied String
Copied Date
Copied Single Selection
Copied Multi Text
Copied Multi Text
Copied String
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Field Type Comments
TAB: Follow Up
SECTION: Record Details
Initiator PersonDate Opened Date/Time
Assigned To Person
IM / Quality Coordinator Person
(Root Parent) Inspection Title Virtual String
(Root Parent) Inspection Start Date Virtual Date
(Root Parent) Inspection End Date Virtual Date
SECTION: Follow Up Detail
Observation Subpart(s) String
Assessment Impact Multi Selection
Description FlexfieldDue Date Date
Original Date Due Date
Date Explicitly Committed To? Single Selection
Associated Record #'s Reference Record
SECTION: Action Plan
Action Plan Flexfield
Evidence for Closure Flexfield
Action Plan Attachments File Attachment
SECTION: Updates
Projected Completion Date DateMost recent status update? Single Selection
Potential miss/overdue? Single Selection
Status Single Selection
Updates Flexfield
SECTION: Closure Summary
Summary of Actions Completed Flexfield
Attachments File Attachment
TAB: Parent / Root Parent Info
(Parent) Obs./Rec. # Virtual String(Parent) Observation Text Virtual Flexfield
SECTION: Parent / Root Parent
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(Parent) Recommendation Text Virtual Flexfield
(Parent) Evaluation Virtual Flexfield
(Root Parent) Inspected Site Virtual Single Selection
(Root Parent) Health Authority Virtual Single Selection
(Root Parent) Other Health Authority Virtual String
(Root Parent) Inspction Start Date Virtual Date
(Root Parent) Inspection Title Virtual String
(Root Parent) Inspection End Date Virtual Date
(Parent) Response Virtual Flexfield
(Root Parent) Inspection Type Single Selection
(Root Parent) Product(s) in Scope Multi Text
(Root Parent) Investigator(s) Multi Text
(Root Parent) Other Health Authority String
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New Field Name
R
N
R
C Associated Record(s)
RN
N
N
Field status based on Prototype 1a/1bfeedback?R = Remove Field
N = New FieldC = Change Field Name (see column
New Field Name)
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C
N
N
N
N
N
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New Field TypeChange Field Type? "Y" (blank = "N")
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Y Copied Single Selection
Y Copied Single Selection
Y Copied String
Y Copied Date
Y Copied String
Y Copied Date
Y Copied Single Selection
Y Copied Multi Text
Y Copied Multi Text
Y Copied String
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Field Type
TAB: Gap Remediation
SECTION: Record Details
Initiator PersonDate Opened Date/Time
Assigned To Person
IM / Quality Coordinator Person
(Root Parent) Inspection Title Virtual String
(Root Parent) Inspection Start Date Virtual Date
(Root Parent) Inspection End Date Virtual Date
SECTION: Gap Remediation Detail
Inspected Site? Single Selection
Observation Subpart(s) String
Assessment Impact Multi SelectionDescription Flexfield
Original Date Due Date
Due Date Date
Date Explicitly Committed To? Single Selection
Associated Record #'s Reference Record
Associated Gap Assessment #'s Reference Record
SECTION: Action Plan
Action Plan Flexfield
Evidence for Closure Flexfield
Action Plan Attachments File AttachmentSECTION: Updates
Projected Completion Date Date
Most recent status update? Single Selection
Potential miss/overdue? Single Selection
Status Single Selection
Updates Flexfield
SECTION: Closure Summary
Summary of Actions Completed Flexfield
Attachments File Attachment
TAB: Parent / Root Parent InfoSECTION: Parent / Root Parent
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(Parent) Observation Text Virtual Flexfield
(Parent) Recommendation Text Virtual Flexfield
(Parent) Evaluation Virtual Flexfield
(Root Parent) Inspected Site Virtual Single Sele
(Root Parent) Health Authority Virtual Single Sele
(Root Parent) Other Health Authority Virtual String
(Root Parent) Inspction Start Date Virtual Date
(Root Parent) Inspection Title Virtual String
(Root Parent) Inspection End Date Virtual Date
(Parent) Response Virtual Flexfield
(Root Parent) Inspection Type Single Selection
(Root Parent) Product(s) in Scope Multi Text
(Root Parent) Investigator(s) Multi Text
(Root Parent) Other Health Authority String
(Parent) Obs./Rec. # Virtual String
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Comments
R
R
N
R
C
C
R
N
N
Field status based on Prototype 1a/1bfeedback?R = Remove Field
N = New FieldC = Change Field Name (see column
New Field Name)
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tion
tion
N
N
N
N
N
N
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New Field Name
Associated Record(s)
Assoc. Gap Assessment Rec(s)
Change Field Type? "Y" (blank = "N")
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Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
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New Field Type
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Copied Single Selection
Copied Single Selection
Copied String
Copied Date
Copied String
Copied Date
Copied Single Selection
Copied Multi Text
Copied Multi Text
Copied String
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Field Type
TAB: Gap Assessment
SECTION: Record Details
Initiator PersonDate Opened Date/Time
Assigned To Person
IM / Quality Coordinator Person
Site Single Selection
Business Unit Single Selection
(Root Parent) Inspection Title Virtual String
(Root Parent) Inspection Start Date Virtual Date
(Root Parent) Inspection End Date Virtual Date
SECTION: Gap Assessment Detail
Inspected Site? Single SelectionImpacted Area Multi Text
GAP Assessment File Attachment
Due Date Date
Gaps? Single Selection
Date Assessment Completed Date
Associated CAPA #'s Reference Record
Action Plan for Remediation File Attachment
Description Flexfield
Assessment Summary Flexfield
SECTION: SummarySummary of Actions Completed Flexfield
Attachments File Attachment
TAB: Parent / Root Parent Info
(Parent) Observation Text Virtual Flexfield
(Parent) Recommendation Text Virtual Flexfield
(Parent) Evaluation Virtual Flexfield
(Root Parent) Inspected Site Virtual Single Sele
(Root Parent) Health Authority Virtual Single Sele
(Root Parent) Other Health Authority Virtual String(Root Parent) Inspction Start Date Virtual Date
SECTION: Parent / Root Parent
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(Root Parent) Inspection Title Virtual String
(Root Parent) Inspection End Date Virtual Date
(Parent) Response Virtual Flexfield
(Root Parent) Inspection Type Single Selection
(Root Parent) Product(s) in Scope Multi Text
(Root Parent) Investigator(s) Multi Text
(Root Parent) Other Health Authority String
(Parent) Obs./Rec. # Virtual String
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Comments
R
R
C
R
R
tion
tion
Field status based on Prototype 1a/1bfeedback?R = Remove Field
N = New FieldC = Change Field Name (see column
New Field Name)
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N
N
N
N
N
N
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New Field Name
Assocaciated Record(s)
Y
Y
YY
Change Field Type? "Y" (blank = "N")
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Y
Y
Y
Y
Y
Y
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New Field Type
Copied Single Selection
Copied Single Selection
Copied StringCopied Date
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Copied String
Copied Date
Copied Single Selection
Copied Multi Text
Copied Multi Text
Copied String
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Field Type
TAB: Recommendation Action(s)
SECTION: Record Details
Initiator PersonDate Opened Date/Time
Assigned To Person
IM / Quality Coordinator Person
(Root Parent) Inspection Title Virtual String
(Root Parent) Inspection Start Date Virtual Date
(Root Parent) Inspection End Date Virtual Date
Inspected Site? Single Selection
Observation Subpart(s) String
Assessment Impact Multi SelectionDescription Flexfield
Original Date Due Date
Due Date Date
Date Explicitly Committed To? Single Selection
Associated Record #'s Reference Record
SECTION: Action Plan
Action Plan Flexfield
Evidence for Closure Flexfield
Action Plan Attachments File Attachment
SECTION: UpdatesProjected Completion Date Date
Most recent status update? Single Selection
Potential miss/overdue? Single Selection
Status Single Selection
Updates Flexfield
SECTION: Closure Summary
Summary of Actions Completed Flexfield
Attachments File Attachment
TAB: Parent / Root Parent Info
(Parent) Observation Text Virtual Flexfield
SECTION: Recommendation Action(s)
SECTION: Parent / Root Parent
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(Parent) Recommendation Text Virtual Flexfield
(Parent) Evaluation Virtual Flexfield
(Root Parent) Inspected Site Virtual Single Sele
(Root Parent) Health Authority Virtual Single Sele
(Root Parent) Other Health Authority Virtual String
(Root Parent) Inspction Start Date Virtual Date
(Root Parent) Inspection Title Virtual String
(Root Parent) Inspection End Date Virtual Date
(Root Parent) Inspection Type Single Selection
(Root Parent) Product(s) in Scope Multi Text
(Root Parent) Investigator(s) Multi Text
(Root Parent) Other Health Authority String
(Parent) Obs./Rec. Virtual String
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Comments
C
N
R
R
N
N
R
Field status based on Prototype 1a/1bfeedback?R = Remove Field
N = New FieldC = Change Field Name (see column
New Field Name)
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tion
tion
N
N
N
N
N
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New Field Name
Sites Potentially Impacted
Change Field Type? "Y" (blank = "N")
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Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
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New Field Type
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Copied Single Selection
Copied Single Selection
Copied String
Copied Date
Copied String
Copied Date
Copied Single Selection
Copied Multi Text
Copied Multi Text
Copied String
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Field Type
TAB: Action
SECTION: Record Details
Initiator PersonDate Opened Date/Time
Assigned To Person
IM / Quality Coordinator Person
Action Record Type Single Selection
SECTION: Action Detail
Site / Group Single Selection
Impacted Area Multi Text
Due Date Date
Description Flexfield
Gaps ? Single SelectionSummary of Actions Completed Flexfield
SECTION: Additional Info.
Additional Info Flexfield
Attachments File Attachment
TAB: Parent / Root Parent Info
(Parent) Observation Subpart(s) Virtual String
(Root Parent) Inspected Site Virtual Single Sele
(Root Parent) Health Authority Virtual Single Sele
(Root Parent) Inspection Start Date Virtual Date(Root Parent) Other Health Authority Virtual String
(Root Parent) Inspection End Date Virtual Date
(Root Parent) Inspection Title Virtual String
(Root Parent) Inspection Type Single Selection
(Root Parent) Product(s) in Scope Multi Text
(Root Parent) Investigator(s) Multi Text
(Root Parent) Other Health Authority String
(Parent) Obs./Rec. Virtual String
SECTION: Parent / Root Parent
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Comments
N
N
N
R
tion
tion
N
N
N
N
N
Field status based on Prototype 1a/1bfeedback?R = Remove Field
N = New FieldC = Change Field Name (see column
New Field Name)
Conditionally shows available
Conditionally Available if "Action
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New Field Name
Y
Y
YY
Y
Y
Y
Y
Y
Y
Change Field Type? "Y" (blank = "N")
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New Field Type
Copied Single Selection
Copied Single Selection
Copied DateCopied String
Copied Date
Copied String
Copied Single Selection
Copied Multi Text
Copied Multi Text
Copied String
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Record Type Order Field
Inspection Assigned To
Inspection Inspection Description
Inspection Inspected Site
Inspection Operational & Business Unit(s)
Inspection Inspection Type
Inspection Product(s) in Scope
Inspection Health Authority
Inspection Other Health Authority
Inspection Inspection Start Date
Inspection Inspection End Date
Inspection Inspection Title
Inspection Inspector / Investigator Name(s)
Inspection Attachments
Inspection Additional Info.
Observation IM / Quality Coordinator
Observation (Parent) *Inspection Title
Observation Observation #Observation Observation Classification
Observation Observation Text
Observation Observation Impact
Observation Defended Subpart
Observation Theme(s)/"Tag(s)"
Observation Repeat Observation?
Observation Response
Observation Additional Info.
Observation Attachments
Recommendation IM / Quality Coordinator
Recommendation (Parent) *Inspection Title
Recommendation Recommendation #Recommendation Observation Classification
Recommendation Recommendation Text
Recommendation Recommendation Impact
Recommendation Defended Subpart(s)
Recommendation Theme(s)/"Tag(s)"
Recommendation Evaluation
Recommendation Action to be Taken?
Recommendation Additional Info.
Recommendation Attachments
Commitment Assigned To
Commitment IM / Quality Coordinator
Commitment (Root Parent) *Inspection Title
Commitment Observation Subpart(s)
Commitment Commitment Impact
Commitment Commitment
Commitment Commitment Summary
Commitment Action Plan
Commitment Evidence for Closure
Commitment Associated Record #'s
Commitment Commitment Due Date
Commitment Date Commitment Met
Commitment Projected Completion Date
Commitment Status
Commitment Updates
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Commitment Follow Up Action Plan
Commitment Commitment Actions Summary
Commitment Additional Info.
Commitment Attachments
Observation Evaluation
Follow Up Assessment Impact
Follow Up Date Explicitly Commited To?
Gap Assessment Site
Gap Assessment "Summary of Actions Completed"
Recommendation Recommendation Impact
Gap Remediation Date Explicitly Commited To?
Recommendation Action Date Explicitly Commited To?
Recommendation Action Projected Completion Date
Action Additional Info.
Gap Assessment Action Plan for Remediation
Gap Assessment
Gap Assessment "Gap Assessment"
Gap Assessment Associated CAPA#'sGap Assessment Date Assessment Completed
Follow Up (Parent) Observation #
Gap Remediation Observation Subpart(s)
Action Additional Info.
Gap Remediation Assessment Impact
Follow Up Assessment Impact
Gap Assessment Impacted Area
Action Impacted Area
Gap Remediation Projected Completion Date
Follow Up Projected Completion Date
Commitment Projected Completion Date
Recommendation Action Projected Completion DateCommitment Commitment Due Date
Gap Remediation Original Date Due
Recommendation Action Original Date Due
Follow Up Original Date Due
Commitment Most recent status update?
Recommendation Action Most recent status update?
Follow Up Most recent status update?
Gap Remediation Most recent status update?
Commitment Potential miss/overdue?
Recommendation Action Potential miss/overdue?
Follow Up Potential miss/overdue?
Gap Remediation Potential miss/overdue?
Action Gaps?
Action Action Record Type
Inspected SiteOperational & Business Unit(s)Inspection TypeProduct(s) in ScopeHealth AuthorityInvestigator(s)Inspection Start DateInspection End Date
Other Health AuthorityInspection Title
needed?
Commitment
Commitment
Commitment
Commitment
Commitment
Commitment
Commitment
Commitment
Commitment
Commitment
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Description Record Type
Person in charge of managing record. Selection
Short description of the inspection Free-text
The Inspected Site Selection
The Operation Unit & Business Unit(s) Inspected Multi-select
Note the Type of Inspection. Selection
Select products in scope of the inspection Multi-select
Selection
Free-text
Note the Inspection Start Date. Date
Note he Inspection End Date. Date
Formula
Attachment
Selection
"Inspection Title" from the Inspection Record Formula
Note the Observation #, e.g. 6.3.1 for EMA and 3 for FDA Free-textNote the classification for the Observation Selection
Paragraph
Multi-select
Free-text
Select the "Theme(s) for the Observation Multi-select
Note whether or not this is a repeat observation Selection
Paragraph
Selection
"Inspection Title" from the Inspection Record Formula
Note the Recommendation # Free-text
Paragraph
Multi-select
Select the "Theme(s) for the Observation Multi-select
Free-text
Based on the "Evaluation" is there action to be taken? Selection
For supplemental attachments supporting the evaluation. Attachment
Selection
Selection
"Inspection Title" from the Inspection Record Formula
Free-text
Note the widest impact of the Commitment. Multi-select
Note what Commitment is being made here. Paragraph
Paragraph
Paragraph
Paragraph
Date
Date all actions to meet the Commitment were completed. Date
Date
Selection
Paragraph
"Other" if value not present.the Health Authority.
propagated to progeny records.
investigator is noted first.
Responses to Agency
record.
this field.determine, which sites need to conduct.
Type "N/A" if no subpart(s) were defended.
field.
record.
recommendation into this field.
the corrective action(s), if any, that need to be taken.
Commitment to completion.ensure that this Commitment is fulfilled in full and on time.
Commitment addresses.
utilized for reporting purposes, e.g. the monthly reportthe Commitment. supplied to indicate the Commitment has been met.
to modify this date.
"Projected Completion Date."
Commitment.Late," then a Status Update Needs to be provided.
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Attachment
Attachment
Paragraph
Multi-select
Single Select
Single Select
Text
Copied Single Selecti
Copied Multi Selectio
Copied Single Selecti
Copied Multi Text
Copied Single Selecti
Copied Multi Text
Copied Date
Copied Date
Copied StringCopied String
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Value(s) When Required?
Vacaville
(Complaints)
inspector physically on-site)
(Other)
Other
Site Only
No
Small Molecules Drug Product
No
Small Molecules Drug Product
Late
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on
on
on
Small Molecules Corporate
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Comments
Cannot concatenate date fields into this.
Inspector names on different lines
Remove this field?
Y
C
R
N
Remove
Remove
Remove
R
Remove
Response renamed to Evaluation
Remove this field?
Remove this field?
New Name)
feedback
"Inspection Title" field?
names?
Authority"
record is attached to the record?
Dates here, because we cannot concatenate it in.
on the values selected here.
agencies?
records.
following some sort of Corporate Action?
dating items. What process do we want to use?
Update" and also pull all the "Status Updates"?
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New Field Name
Defended Subpart(s)
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Associated Records