commitments database prototype 2b issues & suggested changes log with osman's estimates

8/2/2019 Commitments Database Prototype 2b Issues & Suggested Changes Log With Osman's Estimates

1/72

Issue ID Completed? 12/9 Decision 12/9 Notes Type Of Issue

18 Harmonization Medium Priority

23 Accept New Req

Priority ofIssue

Sparta FollowUp


2/72

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?


3/72

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


4/72

Criticality Comments Assigned ToReproducibleSequence

Relevant (TW)Record IDs

ProposedResolution


5/72

Completed On Approved ByActualResolution Items that will

Require Training


6/72

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


7/72

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


8/72

Site / Group Gap Assessment, Gap Remediation, Action Single Selection

Gaps? Gap Assessment, Action Single Selection


9/72

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


10/72

ClarecastleFlorenceGlobalHillsboroIsandoKaiseraugst -

Packinging andSupplyKaiseraugst -ParenteralsKaiseraugst -RocephinManufacturingLeganesMannheim BiologicsMannheim SmallMoleculesNutleyOceanside

PenzbergRio de JaneiroSegrateShanghaiSmall MoleculesCorporateSingapore

YesNo

YesNo

Yes

NoYesNo

YesNo


11/72

ClarecastleFlorenceGlobalHillsboroIsandoKaiseraugst -

Packinging andSupplyKaiseraugst -ParenteralsKaiseraugst -RocephinManufacturingLeganesMannheim BiologicsMannheim SmallMoleculesNutleyOceanside

PenzbergRio de JaneiroSegrateShanghaiSmall MoleculesCorporateSingapore

YesNo


12/72

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.


13/72

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) Other Health Authority 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


14/72

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)


15/72

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")


16/72

New Field Type

Copied SelectionCopied Multi Selection

Copied Single Selection

Copied Date

Copied String

Copied Date

Copied String


Copied Multi Text

Copied Multi Text

Copied String


17/72

Field Type

TAB: Recommendation


Initiator Person

Date Opened Date/Time





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


(Parent) Inspected Site Virtual Selection

(Parent) Operational & Business Unit(s) Virtual Multi Selecti

(Parent) Health Authority Virtual Single Sele


(Parent) Other Health Authority Virtual String


(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



18/72

Comments

C

R

on

tion

N

N

N

N

Field status based on Prototype 1a/1b

feedback?R = Remove Field


New Field Name)


19/72

New Field Name

Obs./Rec. #

Y

Y

Y

Y

Y

Y

YY

Y

Y

Y



20/72

New Field Type

Copied Selection

Copied Multi Selection


Copied Date

Copied String

Copied Date

Copied StringCopied Single Selection

Copied Multi Text

Copied Multi Text

Copied String


21/72

Field Type

TAB: Commitment


Initiator PersonDate Opened Date/Time

Assigned To 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


TAB: Impact

SECTION: Impact

Assessment Impact Multi SelectionTAB: Parent / Root Parent Info


22/72

(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



(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



23/72

Comments

N

C

RN

N

C

Field status based on Prototype 1a/1bfeedback?R = Remove Field


New Field Name)


24/72

R

tion

tion

N

N

N

N

N

N


25/72

New Field Name

Associated Record(s)




26/72

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y


27/72

New Field Type


28/72



Copied String

Copied Date

Copied String

Copied Date


Copied Multi Text

Copied Multi Text

Copied String


29/72

Field Type Comments

TAB: Follow Up



Assigned To Person





SECTION: Follow Up Detail


Assessment Impact Multi Selection

Description FlexfieldDue Date Date

Original Date Due Date







SECTION: Updates

Projected Completion Date DateMost recent status update? Single Selection

Potential miss/overdue? Single Selection


Updates Flexfield


Summary of Actions Completed Flexfield



(Parent) Obs./Rec. # Virtual String(Parent) Observation Text Virtual Flexfield



30/72



(Root Parent) Inspected Site Virtual Single Selection

(Root Parent) Health Authority Virtual Single Selection











31/72

New Field Name

R

N

R

C Associated Record(s)

RN

N

N



New Field Name)


32/72

C

N

N

N

N

N


33/72

New Field TypeChange Field Type? "Y" (blank = "N")


34/72

Y Copied Single Selection


Y Copied String

Y Copied Date

Y Copied String

Y Copied Date


Y Copied Multi Text

Y Copied Multi Text

Y Copied String


35/72

Field Type

TAB: Gap Remediation



Assigned To Person





SECTION: Gap Remediation Detail

Inspected Site? Single Selection


Assessment Impact Multi SelectionDescription Flexfield


Due Date Date



Associated Gap Assessment #'s Reference Record




Action Plan Attachments File AttachmentSECTION: Updates

Projected Completion Date Date

Most recent status update? Single Selection



Updates Flexfield




TAB: Parent / Root Parent InfoSECTION: Parent / Root Parent


36/72

















37/72

Comments

R

R

N

R

C

C

R

N

N



New Field Name)


38/72

tion

tion

N

N

N

N

N

N


39/72

New Field Name

Associated Record(s)

Assoc. Gap Assessment Rec(s)



40/72

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y


41/72

New Field Type


42/72



Copied String

Copied Date

Copied String

Copied Date


Copied Multi Text

Copied Multi Text

Copied String


43/72

Field Type

TAB: Gap Assessment



Assigned To Person


Site Single Selection

Business Unit Single Selection




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








(Root Parent) Other Health Authority Virtual String(Root Parent) Inspction Start Date Virtual Date



44/72










45/72

Comments

R

R

C

R

R

tion

tion



New Field Name)


46/72

N

N

N

N

N

N


47/72

New Field Name

Assocaciated Record(s)

Y

Y

YY



48/72

Y

Y

Y

Y

Y

Y


49/72

New Field Type



Copied StringCopied Date


50/72

Copied String

Copied Date


Copied Multi Text

Copied Multi Text

Copied String


51/72

Field Type

TAB: Recommendation Action(s)



Assigned To Person





Inspected Site? Single Selection


Assessment Impact Multi SelectionDescription Flexfield


Due Date Date







SECTION: UpdatesProjected Completion Date Date

Most recent status update? Single Selection



Updates Flexfield






SECTION: Recommendation Action(s)



52/72













(Parent) Obs./Rec. Virtual String


53/72

Comments

C

N

R

R

N

N

R



New Field Name)


54/72

tion

tion

N

N

N

N

N


55/72

New Field Name




56/72

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y


57/72

New Field Type


58/72



Copied String

Copied Date

Copied String

Copied Date


Copied Multi Text

Copied Multi Text

Copied String


59/72

Field Type

TAB: Action



Assigned To 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



(Parent) Observation Subpart(s) Virtual String



(Root Parent) Inspection Start Date Virtual Date(Root Parent) Other Health Authority Virtual String







(Parent) Obs./Rec. Virtual String



60/72

Comments

N

N

N

R

tion

tion

N

N

N

N

N



New Field Name)

Conditionally shows available

Conditionally Available if "Action


61/72

New Field Name

Y

Y

YY

Y

Y

Y

Y

Y

Y



62/72

New Field Type



Copied DateCopied String

Copied Date

Copied String


Copied Multi Text

Copied Multi Text

Copied String


63/72

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


64/72

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


65/72

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


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


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.


66/72

Attachment

Attachment

Paragraph

Multi-select

Single Select

Single Select

Text

Copied Single Selecti

Copied Multi Selectio


Copied Multi Text


Copied Multi Text

Copied Date

Copied Date

Copied StringCopied String


67/72

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


68/72

on

on

on

Small Molecules Corporate


69/72

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"?


70/72


71/72

New Field Name

Defended Subpart(s)


72/72

Associated Records

commitments database prototype 2b issues & suggested changes log with osman's estimates

Documents