PV Monitor Foresight Group International AG Submission Performance and Case List(s) (Report C11a) Traceability Matrix

Version 04.01

PV Monitor Traceability Matrix, v01.00

Table of Contents
1. DOCUMENT HISTORY...............................................................................................................3 2. APPROVAL STATEMENT..........................................................................................................4 3. TRACEABILITY INFORMATION.................................................................................................5 4. TRACEABILITY RELATIONSHIPS.............................................................................................5 5. TRACEABILITY MATRIX............................................................................................................6

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1.

Document History
Modification Date 14-Aug-2012 Author Sumeet Raina Summary of Changes Initial Issuance

Version 01.00

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2.

Approval Statement

The undersigned agree that the traceability matrix detailed in this document for the PV Monitor application accurately depicts the relationship among the required functionality, the Qualification Tests and the System Design Specification. Name Richard Schrock Bill Parnell Stephen A. Wright Function Project Manager Technical Architect Quality Manager Date Signature

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3.

Traceability Information

The relationships are specified as follows, Ancestor Relationship Descendent. The relationships will be traced in the following order of precedence. User and Functional Requirement(s) <<>> Technical Specifications User and Functional Requirement(s) <>> Qualification Test(s)

The double-to-double arrowhead (<<>>) indicates a many to many relationship. The single to double arrowhead (<>>) indicates a one to many relationship.

4.

Traceability Relationships

For each numbered user requirement one or more items in the Technical Specification and Qualification (OQ) are present. The matrix in the next section of this document illustrates this relationship. All items in the User and Functional Requirements Specification have been accounted for.

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5.

Traceability Matrix
Requirement Type Title Description Requirement The report identifier shall be R_C11a This report provides a summary on expedited submissions to a selected receiver ( agencies, Licence partners, affiliates ) or a receiver grouping name during a queried submission period with Lateness reason and associated corrective and preventive actions (CAPA). Users may specify the input parameters: Submission Date Range, Receiver name, receiver region, Collection Organization Name, Primary Reporter Country, Suspected Drug, Licence type, WFCP, Submission Timeframe, Metrics, Deleted cases, Nullified submissions, Exclusion Tags, Summary period and the Disclaimer to be used. The report output displays the submission counts (Total, ontime, late), Submission performances (percent on-time and Late) and/or the Case list of submitted reports with details. The report title displayed in the PVM Reports tab shall be Submission Performance and Case List(s) The report title printed for the Submission Performance Summary sub-report shall be Submission Performance The report title printed for Case List 1 shall be Case List of All Expedited Submissions (1) The report title printed for Case List 2 shall be Case List of Late Expedited Submissions with Lateness Reason and Associated CAPA (2) The report title printed for Case List 3 shall be Case List of Late Expedited Submissions with Lateness Reason and Associated CAPA (3) System Design Specification Section 6.2.1 NA OQ 37, OQ 38, OQ 39, OQ 40 OQ Test Case Reference(s) OQ 37, OQ 38, OQ 39, OQ 40

UFR Paragraph
C11A.4.1.1 C11A.4.1.2

C11A.4.1.3

Title Title Title Title

6.2.1 6.2.1 6.2.1 6.2.1

OQ 37, OQ 38, OQ 39, OQ 40 OQ 37 OQ 38 OQ 39

C11A.4.1.4

C11A.4.1.5

C11A.4.1.6

C11A.4.1.7

Title

6.2.1

OQ 40

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C11A.4.1.8

Requirement Type Footer

Requirement This report provides a submission summary and case list(s) for the period <StartDate> to <EndDate>]. Submissions sent to the following receivers [ALL OR <ReceiverRegions> OR <ReceiverOrgs> OR <ReceiverTypes>] are included. Submissions having the following timelines [ALL OR <SubmissionTimelines>] are included. This report excludes submissions with the following tags: [NONE OR <ExclusionListSubmission>]. This report excludes submissions having case versions with the following tags: [NONE OR <ExclusionListCaseVersion>]. Confidential

System Design Specification Section 6.1.3

OQ Test Case Reference(s) OQ 37, OQ 38, OQ 40

C11A.4.1.9

Parameters Parameters Parameters

A Submission From Date parameter shall be provided A date entry field with calendar button. A value is mandatory. A Submission To Date parameter shall be provided A date entry field with calendar button. A value is mandatory A To Receiver Region parameter shall be provided A multi-select dropdown. No default values selected. Regions (see note) defined in the lookup table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When values are selected then only those submissions matching (having a Receiver Country in) the selected Region(s) will be included

6.2.5 6.2.5 6.2.5

OQ 37 OQ 37 OQ 37

C11A.4.1.10

C11A.4.1.11

* Note: Only Regions identified as Country type will be displayed in the dropdown. Collection Only type Regions will not be displayed. Country Region Type is identified using Region Custom Attribute2 = COUNTRY. ** Note: Regions are mapped to Countries (using Country Custom Attribute1=[Region]) and Countries are mapped to Receivers. EMA and LP are being added as special countries to support EMA and LP regions.
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C11A.4.1.12

Requirement Type Parameters

Requirement A To Receiver Name parameter shall be provided A multi-select dropdown. No default values selected. All Receivers defined in the Receiver Organization table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions matching the selected Receiver(s) will be included

System Design Specification Section 6.2.5

OQ Test Case Reference(s) OQ 37

C11A.4.1.13

Parameters

A To Receiver Type parameter shall be provided A multiselect dropdown. No default values selected. All Receivers Types defined in the lookup table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions matching the selected Receiver Type(s) will be included

6.2.5

OQ 37

C11A.4.1.14

Parameters

A Show Performance\List(s) parameter shall be provided A multi-select dropdown. Values include: <blank> The default value. Show the Submission Performance and all Case List sections Submission Performance Summary Case List 1 - All Expedited Submissions Case List 2 - Late Expedited Submissions with Lateness Reason and Associated CAPA Case List 3 - Late Expedited Submissions with Lateness Reason and Associated CAPA

6.2.5

OQ 37

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C11A.4.1.15

Requirement Type Parameters

Requirement A Summary Period parameter shall be provided A single select dropdown. Values include: <Blank> The default value. Group summary values by the reporting period Weekly Group summary values by week Monthly Group summary values by month Quarterly Group summary values by quarter Yearly Group summary values by year

System Design Specification Section 6.2.5

OQ Test Case Reference(s) OQ 37

C11A.4.1.16

Parameters

A Report Type parameter shall be provided A multiselect dropdown. No default value selected. All Report Types (e.g., Solicited, Unsolicited) defined in the lookup table will be displayed as valid values to choose from. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions matching the selected Report Type will be included

6.2.5

OQ 37

C11A.4.1.17

Parameters

A From Collection Org Name parameter shall be provided A multi-select dropdown. No default values selected. All Collection Orgs defined in the Collection Organization table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions matching the selected Collection Org(s) will be included

6.2.5

OQ 37

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C11A.4.1.18

Requirement Type Parameters

Requirement A From Collection Org Types parameter shall be provided A multi-select dropdown. No default values selected. All Collection Org Types (e.g., REG, NREG, etc) defined in the lookup table will be displayed as valid values to choose from. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions matching the selected Collection Org Type(s) will be included

System Design Specification Section 6.2.5

OQ Test Case Reference(s) OQ 37

C11A.4.1.19

Parameters

A Any Suspect Products parameter shall be provided A multi-select dropdown. No default values selected. All Products defined in the lookup table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions with a case version having any suspect product matching the selected Product(s) will be included

6.2.5

OQ 37

C11A.4.1.20

Parameters

A License Type parameter shall be provided A multiselect dropdown. No default values selected. All License Types defined in the lookup table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions matching the selected License Type(s) will be included

6.2.5

OQ 37

* Note: A new License Type (Custom) lookup definition will be created for this dropdown.

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C11A.4.1.21

Requirement Type Parameters

Requirement A Primary Reporter Country parameter shall be provided A multi-select dropdown. No default values selected. All Countries defined in the Country Lookup table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions matching the selected Reporter Country(s) will be included

System Design Specification Section 6.2.5

OQ Test Case Reference(s) OQ 37

C11A.4.1.22

Parameters

A Late Metrics to Include parameter shall be provided A multi-select dropdown. No default values selected. All Metrics (e.g., M1, M2, M3, M4, etc) defined in the Metric Activity table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions having related Late Metrics matching the selected Metric(s) will be included

6.2.5

OQ 37

C11A.4.1.23

Parameters

An AND \ OR (Late Metrics) parameter shall be provided A single select dropdown. The default value is OR. Values include: All metrics must match (AND) All submissions with related late metrics matching all the selected metrics will be included At least one metric must match (OR) All submissions with related late metrics matching at least one of the selected metrics will be included

6.2.5

OQ 37

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C11A.4.1.24

Requirement Type Parameters

Requirement A On-time Metrics to Include parameter shall be provided A multi-select dropdown. No default values selected. All Metrics (e.g., M1, M2, M3, M4, etc.) defined in the Metric Activity table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions having related Ontime Metrics matching the selected Metric(s) will be included

System Design Specification Section 6.2.5

OQ Test Case Reference(s) OQ 37

C11A.4.1.25

Parameters

An AND \ OR (Ontime Metrics) parameter shall be provided A single select dropdown. The default value is OR. Values include: All metrics must match (AND) All submissions with related ontime metrics matching all the selected metrics will be included At least one metric must match (OR) All submissions with related ontime metrics matching at least one of the selected metrics will be included

6.2.5

OQ 37

C11A.4.1.26

Parameters

A Processing Priority (WFCP) parameter shall be provided A multi-select dropdown. No default values selected. All Processing Priorities (e.g., CLASS 1 ICSR, CLASS 2 DC, etc.) defined in the Processing Priority Lookup table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions matching the selected Processing Priority(s) will be included

6.2.5

OQ 37

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C11A.4.1.27

Requirement Type Parameters

Requirement A Processing Organization parameter shall be provided A multi-select dropdown. No default values selected. All Processing Organizations defined in the Processing Organization Lookup table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions having case versions matching the selected Processing Organization(s) will be included

System Design Specification Section 6.2.5

OQ Test Case Reference(s) OQ 37

C11A.4.1.28

Parameters

A Submission Timeframes parameter shall be provided A multi-select dropdown. No default values selected. All Submission Timeframes (e.g., 5-Day, 7-Day, 15-Day, etc.) defined in the Submission Timeline Lookup table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then only those submissions matching the selected Timeline(s) will be included

6.2.5

OQ 37

C11A.4.1.29

Parameters

A Deleted Cases parameter shall be provided A single select dropdown. Values include: <Blank> The default value. All submissions are included (unless excluded per another parameter) Exclude All submissions having an active (nondeleted) case and an active (non-deleted) case version will be included Deleted Only All submissions having a deleted case or deleted case version will be included

6.2.5

OQ 37

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C11A.4.1.30

Requirement Type Parameters

Requirement A Nullified Submissions parameter shall be provided A single select dropdown. Values include: <Blank> The default value. All submissions (Active and Nullified) are included (unless excluded per another parameter) Exclude All active (non-nullified) submissions will be included Nullified Only All submissions having a Nullified will be included

System Design Specification Section 6.2.5

OQ Test Case Reference(s) OQ 37

C11A.4.1.31

Parameters

A Exclusion Tags (Submission) parameter shall be provided A multi-select dropdown. No default values selected. All Tags defined in the Tags Lookup table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then those submissions with tags matching the selected Tag(s) will be excluded

6.2.5

OQ 37

C11A.4.1.32

Parameters

A Exclusion Tags (Case Version) parameter shall be provided A multi-select dropdown. No default values selected. All Tags defined in the Tags Lookup table will be displayed as values. When no value is selected then all submissions are included (unless excluded per another parameter) When value(s) are selected then those submissions having related case versions with tags matching the selected Tag(s) will be excluded

6.2.5

OQ 37

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C11A.4.1.33

Requirement Type Parameters

Requirement A Disclaimer parameter shall be provided A single select dropdown. Values include: DRAFT The default value. The draft disclaimer will be displayed. OFFICIAL The draft disclaimer will NOT be displayed.

System Design Specification Section 6.2.5

OQ Test Case Reference(s) OQ 37

C11A.4.1.34

Parameters

All dropdown lists having a Sort Order field in the source data will be sorted by: Sort Order, [Description|Name| Decode] Only submissions meeting the inclusion criteria specified below shall be included in the report. Inclusion Criteria: The Submission Date must be on or after the specified Submission From Date parameter. And, the Submission Date must be on or before the specified Submission To Date parameter. And, the submission must meet one of the following Receiver conditions: o If a Region is selected then it must match any of the To Receiver Region parameter selections. o Or, if a Receiver is selected then it must match any of the To Receiver Name parameter selections. o Or, if a Receiver Type is selected then it must match any of the To Receiver Type parameter selections. o Otherwise, when Receiver conditions are NOT specified a filter is not applied for this condition. And, the Report Type for the related case version must match any Report Type parameter value selected. When NOT specified a filter is not applied for this condition.

6.2.5

OQ 37

C11A.4.1.35

Criteria

6.2.5

OQ 37, OQ 38, OQ 39, OQ 40

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement And, the submission must meet one of the following Collection Organization conditions: o If a Collection Organization is selected then it must match any of the From Collection Org Name parameter values selected. o Or, if a Collection Org Type is selected then it must match any of the From Collection Org Types parameter values selected. o Otherwise, when Collection Organization conditions are NOT specified a filter is not applied for this condition. And, the related case must have at least one suspect product matching any of the Any Suspect Products parameter values selected. When NOT specified a filter is not applied for this condition. And, the Submission Title Code must be LIKE any of the License Type parameter values selected. When NOT specified a filter is not applied for this condition. And, the Reporter Country of the related case must match any of the Primary Reporter Country parameter values selected. When NOT specified a filter is not applied for this condition. And, the related case for the submission must match one of the following Late Metrics conditions: o The AND / OR (Late Metrics) parameter value is AND and the related case has LATE metrics matching ALL of the Late Metrics to Include parameter values selected. Note: When the M3 is selected it must be the M3 related to the submission. o The AND / OR (Late Metrics) parameter value is OR and the related case has LATE metrics matching at least ONE of the System Design Specification Section OQ Test Case Reference(s)

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement Late Metrics to Include parameter values selected. Note: When the M3 is selected it must be the M3 related to the submission. When Late Metrics to Include are NOT specified a filter is not applied for this condition. System Design Specification Section OQ Test Case Reference(s)

And, the related case for the submission must match one of the following Ontime Metrics conditions: o The AND / OR (Ontime Metrics) parameter value is AND and the related case has ONTIME metrics matching ALL of the Ontime Metrics to Include parameter values selected. Note: When the M3 is selected it must be the M3 related to the submission. o The AND / OR (Ontime Metrics) parameter value is OR and the related case has ONTIME metrics matching at least ONE of the Ontime Metrics to Include parameter values selected. Note: When the M3 is selected it must be the M3 related to the submission. o When Ontime Metrics to Include are NOT specified a filter is not applied for this condition. And, the Processing Priority for the related case must match any of the Processing Priority (WFCP) parameter values selected. When NOT specified a filter is not applied for this condition. And, the Processing Organization for the related case must match any of the Processing Organization parameter values selected. When NOT specified a filter is not applied for this condition.
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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement And, the Submission Timeline must match any of the Submission Timeframes parameter values selected. When NOT specified a filter is not applied for this condition. And, when the Deleted Cases parameter value is: o Exclude Then only submissions having an active (non-deleted) case AND an active (non-deleted) case version will be included o Deleted Only Then only submissions having a deleted case or deleted case version will be included o Otherwise, when no value is specified a filter is not applied for this condition. And, when the Nullified Submissions parameter value is: o Exclude Then only active (non-nullified) submissions will be included o Nullified Only Then only nullified submissions will be included o Otherwise, when no value is specified a filter is not applied for this condition. 6.2.5 OQ 37, OQ 38, OQ 39, OQ 40 System Design Specification Section OQ Test Case Reference(s)

C11A.4.1.36

Criteria

Submissions meeting the exclusion criteria specified below shall NOT be included in the report. Exclusion Criteria: Exclude submissions having tags matching any of the Exclusion Tags (Submission) parameter values selected. When NOT specified a filter is not applied for this condition. And, exclude submissions with related cases versions having tags matching any of the Exclusion Tags (Case Version) parameter values selected. When NOT specified a filter is not applied for this condition.

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C11A.4.1.37

Requirement Type Output

Requirement The report shall include the following sections / sub-reports (as determined by the selection in the Show Performance\List(s) parameter): Submission Performance Summary Case List 1 - All Expedited Submissions Case List 2 - Late Expedited Submissions with Lateness Reason and Associated CAPA. Optimized for Excel output. Only Late submissions are included. Case List 3 - Late Expedited Submissions with Lateness Reason and Associated CAPA. Optimized for PDF output. Only Late submissions are included.

System Design Specification Section 6.2, 6.2.5

OQ Test Case Reference(s) OQ 37

C11A.4.1.38

Output Output

Each report section / sub-report shall be separated by a page break. The user shall optionally print the report to one of the following: PDF Excel

6.2.3 6.2.5

OQ 37, OQ 38, OQ 39, OQ 40 OQ 37, OQ 38

C11A.4.1.39

C11A.4.1.40

Output Output Output Section

When printing to Excel the report headers, and the report footers shall not be printed. The report shall be formatted to print on A4 size paper. The report print orientation shall be landscape. The Submission Performance Summary section shall be displayed when the Show Performance\List(s) has one of the following parameter values selected: Submission Performance Summary Or, no values are selected

6.1.3 6.2.2 6.2.2 6.2.5

OQ 37, OQ 38, OQ 39, OQ 37, OQ 38, OQ 39, OQ 40 OQ 37, OQ 38, OQ 39, OQ 40 OQ 37

C11A.4.1.41 C11A.4.1.42 C11A.4.1.43

C11A.4.1.44

Fields

The Submission Performance Summary section of the report

6.2.6

OQ 37

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement shall have the following fields: Group1 (Region or Country Name or Receiver Organization Name) o If Region parameter selected (and not Receiver Name or Receiver Type) then Group1 is Region o If Receiver Name or Receiver Type parameter is selected and Receiver is a Health Authority or Affiliate then Group1 is Country Name o If Receiver Name or Receiver Type parameter is selected and Receiver is a License Partner then Group1 is Receiver Organization Name Agency (Country Name or Receiver Organization) o If the Receiver is a Health Authority or Affiliate then Agency is Country Name o If the Receiver is a License Partner then Agency is Receiver Organization Name Receiver Grouping Name (e.g., DEU (BfArM), DEU (PEI), USA (FDA) IND, USA (FDA) NDA, etc.) o If not empty then use Receiver Grouping Name o If it is empty then use the string ** Receiver Grouping Name Missing concatenated with the Receiver Organization in parenthesis, e.g., ** Receiver Grouping Name Missing (USA) Submission Timeline (e.g., 7-Day, 15-Day) Period The report summary period (e.g., Reporting Period, Weekly, Monthly, etc.) Submission Counts: Total The sum of all
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System Design Specification Section

OQ Test Case Reference(s)

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement submissions for the group
C11A.4.1.45

System Design Specification Section

OQ Test Case Reference(s)

Submission Counts: Late The sum of late submissions for the group Submission Counts: Ontime The sum of ontime submission for the group Submission Performance: % Late The percentage of late submissions for the group Submission Performance: % Ontime The percentage of ontime submissions for the group 6.2.6 OQ 37

Sorting

The Submission Performance Summary section shall be sorted by: Group1 Sort Order Group1 Agency Receiver Grouping Name Submission Timeline Summary Period

C11A.4.1.46

Grouping

The Submission Performance Summary section shall be grouped by: Group1 (page break after each group) Agency Receiver Grouping Name Submission Timeline Summary Period

6.2.6

OQ 37

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C11A.4.1.47

Requirement Type Totals

Requirement The Submission Performance Summary section shall be have the following totals: Submission Timeline Totals Receiver Grouping Name Totals Agency Totals (Include only when Group1 is Region) Group1 Totals (repeat column headers) Grand Totals (page break before printing the grand totals; repeat column headers replacing Group1 label with Grand Totals)

System Design Specification Section 6.2.6

OQ Test Case Reference(s) OQ 37

C11A.4.1.48

Section

The Case List 1 section (Excel and PDF) shall be displayed when the Show Performance\List(s) has one of the following parameter values selected: Case List 1 - All Expedited Submissions Or, no values are selected

6.2.5

OQ 38

C11A.4.1.49

Section Fields

The Case List 1 section shall use FontArial for report body text. The Case List 1 section of the report shall have the following fields: Case ID The case number. The text is bold and the color is red. Ver The report sequence number or version number Report Type If the case version is Unsolicited then display Unsol. If the case version is Solicited then display Sol. WFCP The case version workflow priority (Processing Priority Code in PVM). Display the code value. 1st Rptr Cntry The Primary Reporter Country. Display the code value.

NA 6.2.6

OQ 38

C11A.4.1.50

OQ 38

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement 1st Suspect Product The Primary Suspect Product Ser? The seriousness of the case version. If Serious then Y. Otherwise the value displayed is empty. D/LT? If the case version is Fatal then D If Life Threatening then LT. If both then D/LT. Otherwise the value displayed is empty Unexp? - If the case version is Unexpected then Y. Otherwise the value displayed is empty Lit? If the case version is Literature then Y. Otherwise the value displayed is empty. Del? If the Case or Case Version is deleted then Y. Otherwise the value displayed is empty. Nul? If the submission is nullified the Y . Otherwise the value displayed is empty. M4 Over? If the M4 Override flag is Yes then Y. Otherwise the value displayed is empty M4 Override Reason If an override reason exists then display the override reason. Otherwise the value displayed is empty. Note: PVM now supports inactive lookup values. Any inactive text values, x(**Inactive value**), will be removed from the configuration. Late? The M4 Compliance. If the M4 is Late then display Y. Otherwise the value displayed is empty Receipt Date The M4 Start Date. Formatted as DD-MMM-YY, e.g., 12-MAY-12. Subm Date The M4 End Date. Formatted as DDMMM-YY, e.g., 12-MAY-12. Subm Days (Act in Cd.) The M4 actual number of calendar days. Subm Days(Std in Cd.) The M4 standard number
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System Design Specification Section

OQ Test Case Reference(s)

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement of calendar days. Days Late(Cd): When late, the difference between Subm Days (Act) and Subm Days(Std). When NOT late, no value is displayed. The value is highlighted in red. Receiver Grouping Name The Receiver Grouping Name given to the related submission definition related to the M4 metric. If it is empty then use the string ** Receiver Grouping Name Missing concatenated with the Receiver Organization in parenthesis, e.g., ** Receiver Grouping Name Missing (USA). The text is bold and the color is red. 6.2.6 OQ 38 Group1 Sort Order Group1 Agency Receiver Grouping Name Submission Timeline Summary Period Case # Version # 6.2.5 OQ 37,OQ 39 System Design Specification Section OQ Test Case Reference(s)

C11A.4.1.51

Sorting

The Case List 1 section shall be sorted by:

C11A.4.1.52

Section

The Case List 2 (optimized for Excel) section shall be displayed when the Show Performance\List(s) has one of the following parameter values selected: Case List 2 - Late Expedited Submissions with Lateness Reason and Associated CAPA

Or, no values are selected And, only display when Excel is selected for output even if Case List 2 is selected.

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C11A.4.1.53

Requirement Type Section Criteria

Requirement The Case List 2 section shall use FontArial for report body text. In addition to the overall report criteria, the Case List 2 section limits the results to the following: Late Submissions only Other late metrics related to the late submission

System Design Specification Section NA 6.2.5

OQ Test Case Reference(s) OQ 39 OQ 39

C11A.4.1.54

C11A.4.1.55

Fields

The Case List 2 section of the report shall have the following fields: Case ID The case number. The text is bold and the color is red. Ver The report sequence number or version number Report Type If the case version is Unsolicited then display Unsol. If the case version is Solicited then display Sol. WFCP The case version workflow priority (Processing Priority Code in PVM). Display the code value. Collection Org The Collection Organization of the case. Display the code value 1st Rptr Cntry The Primary Reporter Country. Display the code value. 1st Suspect Product The Primary Suspect Product Ser? The seriousness of the case version. If Serious then Y. Otherwise the value displayed is empty. D/LT? If the case version is Fatal then D If Life Threatening then LT. If both then D/LT. Otherwise the value displayed is empty Unexp? - If the case version is Unexpected then Y. Otherwise the value displayed is empty

6.2.6

OQ 39

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement Lit? If the case version is Literature then Y. Otherwise the value displayed is empty. Del? If the Case or Case Version is deleted then Y. Otherwise the value displayed is empty. Nul? If the submission is nullified the Y . Otherwise the value displayed is empty. M4 Over? If the M4 Override flag is Yes then Y. Otherwise the value displayed is empty M4 Override Reason If an override reason exists then display the override reason. Otherwise the value displayed is empty. Note: PVM now supports inactive lookup values. Any inactive text values, x(**Inactive value**), will be removed from the configuration. Receipt Date The M4 Start Date. Formatted as DD-MMM-YY, e.g., 12-MAY-12. Subm Date The M4 End Date. Formatted as DDMMM-YY, e.g., 12-MAY-12. Subm Days (Act in Cd.) The M4 actual number of calendar days. Subm Days(Std in Cd.) The M4 standard number of calendar days. Days Late(Cd): When late, the difference between Subm Days (Act) and Subm Days(Std). When NOT late, no value is displayed. The value is highlighted in red. Receiver Grouping Name The Receiver Grouping Name given to the related submission definition related to the M4 metric. If it is empty then use the the string ** Receiver Grouping Name Missing concatenated with the Receiver Organization in parenthesis, e.g., ** Receiver Grouping Name Missing (USA). The text is bold and the color is red.
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System Design Specification Section

OQ Test Case Reference(s)

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement Metric The Metric Display code, e.g., M1, M2, M3, etc. Lateness Reason for Late Metric A concatenation of the following: o Metric Code in parenthesis o o Metric description The Lateness Reason assigned to the late metric. System Design Specification Section OQ Test Case Reference(s)

Lateness Comment The Lateness Comment entered for the late metric. Responsible Org A concatenation of all the Responsible Organization(s) assigned to the late metric. Note: PVM now supports inactive lookup values. Any inactive text values, x(**Inactive value**), will be removed from the configuration. Tag A concatenation of all the Tag(s) assigned to the late metric. Note: PVM now supports inactive lookup values. Any inactive text values, x(**Inactive value**), will be removed from the configuration. Action Plan ID The action plan assigned ot the late metric. Action Type A concatenation of all the Action Type(s) for each action in the plan. Sorted in Action # order. Action Owner A concatenation of all the Action Owner(s) for each action in the plan. Sorted in Action # order. Action Planned Date A concatenation of all the Action Planned Date(s) for each action in the plan. Format dates as DD-MMM-YY, e.g., 12-MAY-12. Sorted in Action # order. Action Implemented Date A concatenation of all

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement the Action Implemented Date(s) for each action in the plan. Format dates as DD-MMM-YY, e.g., 12MAY-12. Sorted in Action # order. The Implementation date is calculated as Action Completion Date when Status = Implemented. Action Implemented (or Planned) A concatenation of all the Action Implemented values for each action in the plan. Sorted in Action # order. If the Action Implemented entry is empty then display the Action Planned entry prefixed with Planned:. 6.2.6 OQ 39 Group1 Sort Order Group1 Agency Receiver Grouping Name Submission Timeline Summary Period Case # Version # Metric Sort Order 6.2.5 OQ 37, OQ 40 System Design Specification Section OQ Test Case Reference(s)

C11A.4.1.56

Sorting

The Case List 2 section shall be sorted by:

C11A.4.1.57

Section

The Case List 3 (optimized for PDF) section shall be displayed when the Show Performance\List(s) has one of the following parameter values selected: Case List 3 - Late Expedited Submissions with Lateness Reason and Associated CAPA

Or, no values are selected And, only display when PDF is selected for output even if Case List 3 is selected.
C11A.4.1.58

Section

The Case List 3 section shall use Font Arial for report body text.

NA

OQ 40

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph

C11A.4.1.59

Requirement Type Criteria

Requirement In addition to the overall report criteria, the Case List 3 section limit the results to the following: Late Submissions only Other late metrics related to the late submission

System Design Specification Section 6.2.5

OQ Test Case Reference(s) OQ 40

C11A.4.1.60

Fields

The Submission Case List 3 section of the report shall have the following fields: Case ID The case number. The text is bold and the color is red. Ver The report sequence number or version number Report Type If the case version is Unsolicted then display Unsol. If the case version is Solicited then display Sol. WFCP The case version workflow priority (Processing Priority Code in PVM). Display the code value. 1st Rptr Cntry The Primary Reporter Country. Display the code value. 1st Suspect Product The Primary Suspect Product Ser? The seriousness of the case version. If Serious then Y. Otherwise the value displayed is empty. Receipt Date The M4 Start Date. Formatted as DD-MMM-YY, e.g., 12-MAY-12. Subm Date The M4 End Date. Formatted as DDMMM-YY, e.g., 12-MAY-12. Subm Days (Act In Cd) The M4 actual number of calendar days. Subm Days(Std in Cd.) The M4 standard number of calendar days. Days Late(Cd): When late, the difference between

6.2.6

OQ 40

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement Subm Days (Act) and Subm Days(Std). When NOT late, no value is displayed. The value is highlighted in red. Receiver Grouping Name The Receiver Grouping Name given to the related submission definition related to the M4 metric. If it is empty then use the string ** Receiver Grouping Name Missing concatenated with the Receiver Organization in parenthesis, e.g., ** Receiver Grouping Name Missing (USA). The text is bold and the color is red. Lateness Reason for Late Metric A concatenation of the following: o Metric Code in parenthesis o o Metric description The Lateness Reason assigned to the late metric. System Design Specification Section OQ Test Case Reference(s)

Lateness Comment The Lateness Comment entered for the late metric. Responsible Org A concatenation of all the Responsible Organization(s) assigned to the late metric. Note: PVM now supports inactive lookup values. Any inactive text values, x(**Inactive value**), will be removed from the configuration. Tag A concatenation of all the Tag(s) assigned to the late metric. Note: PVM now supports inactive lookup values. Any inactive text values, x(**Inactive value**), will be removed from the configuration. Action Plan ID The action plan assigned ot the late metric. Action Type A concatenation of all the Action Type(s) for each action in the plan. Sorted in Action # order.
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PV Monitor Traceability Matrix, v01.00 UFR Paragraph Requirement Type Requirement Action Owner A concatenation of all the Action Owner(s) for each action in the plan. Sorted in Action # order. Action Planned Date A concatenation of all the Action Planned Date(s) for each action in the plan. Format dates as DD-MMM-YY, e.g., 12-MAY-12. Sorted in Action # order. Action Implemented Date A concatenation of all the Action Implemented Date(s) for each action in the plan. Format dates as DD-MMM-YY, e.g., 12MAY-12. Sorted in Action # order. The Implementation date is calculated as Action Completion Date when Status = Implemented. Action Implemented (or Planned) A concatenation of all the Action Implemented values for each action in the plan. Sorted in Action # order. If the Action Implemented entry is empty then display the Action Planned entry prefixed with Planned:. 6.2.6 OQ 40 Group1 Sort Order Group1 Agency Receiver Grouping Name Submission Timeline Summary Period Case # Version # Metric Sort Order 6.2.1 OQ 37, OQ 38, OQ 39, OQ 40 System Design Specification Section OQ Test Case Reference(s)

C11A.4.1.61

Sorting

The Submission Case List 3 section shall be sorted by:

C11A.4.2.1

General: Report Title

Each report displays its title in the header of the report.

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph

C11A.4.2.2

Requirement Type General: Logo General: Report Parameters General: Unique Report Identifier General: Data Formatting

Requirement The company logo will be displayed in the header of each page Each report shall have the parameter values, if any, used to execute the report placed in the cover page. Each report shall be assigned a unique alphanumeric identifier, and this number shall be included on the report for easy identification. Date values shall be formatted in European data format as follows: DD-MMM-YYYY (ex: 01-JAN-2007), unless otherwise specified. This format applies to all dates unless otherwise specified and includes but is not limited to: 1. Start Date (in headers and footers) 2. End Date (in headers and footers) 3. Data Generated Date (in headers) 4. Output Generated Date (in headers) Each report shall include the date and time that the most recent case version was extracted from the safety system according to the information in the data extract file. Each report shall include the date and time that the report was created. Each report shall have a report description in the footer. Each report shall have page numbers. The following format shall be used, Page ## of ##. The system shall include the following in the footer if user selects the DRAFT disclaimer for the report: DRAFT For Information Purposes Only

System Design Specification Section 6.2.1 6.1.1 6.2.1

OQ Test Case Reference(s) OQ 37, OQ 38, OQ 40 OQ 37, OQ 38, OQ 39, OQ 40 OQ 37, OQ 38, OQ 39, OQ 40 OQ 37, OQ 38, OQ 39, OQ 40

C11A.4.2.3

C11A.4.2.4

C11A.4.2.5

NA

C11A.4.2.6

General: Date Report Generated General: Date Report Created General: Report Description Footer General: Report Page Numbers General: Draft Disclaimer

NA

OQ 37, OQ 38, OQ 39, OQ 40 OQ 37, OQ 38, OQ 39, OQ 40 OQ 37, OQ 38, OQ 40 OQ 37, OQ 38, OQ 40 OQ 37, OQ 38, OQ 40

C11A.4.2.7

NA

C11A.4.2.8

6.1.3 NA 6.2.5

C11A.4.2.9

C11A.4.2.10

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PV Monitor Traceability Matrix, v01.00 UFR Paragraph

C11A.4.2.11

Requirement Type General: Official Disclaimer

Requirement The system shall remove the DRAFT disclaimer if user selects the OFFICIAL disclaimer for the report.

System Design Specification Section 6.2.5

OQ Test Case Reference(s) OQ 37, OQ 38, OQ 40

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