Attachment_8_-_Electronic_State_Access_to_Field_Accomplishments_and_Compliance_Tracking_System_(eSAF).pdf

Attachment 10

FDA Office of Regulatory Affairs State Access to Field Accomplishments and Compliance Tracking System

Task No. TO28 — Contract No. 223-97-5513

Electronic State Access to Field Accomplishments and Compliance Tracking System (eSAF) eSAF Requirements Document

FINAL

August 1, 2002

Prepared By

Food and Drug Administration

August 1, 2002 i

Table of Contents

1. INTRODUCTION

2. ASSUMPTIONS

3. PROCESS FLOWS

4. REQUIREMENTS

4.1.1 1.0 Request State Inspections

4.1.2 2.0 Record Inspection Results

4.1.3 3.0 Review Inspection Results (FDA)

Table of Figures

Figure 3-1. eSAF High-Level Process Flow Figure 3-2. 1.0 Request State Inspections Figure 3-3. 2.0 Record Inspection Results Figure 3-4. 3.0 Review Inspection Results Figure 3-5 2.3.2 Submit Inspection Results to FDA (Batch)

August 1, 2002 1

1. INTRODUCTION

Under its regulatory authority, the Food and Drug Administration (FDA) performs inspections of food facilities around the country in order to ensure compliance with government mandates for food safety. Due to the volume of inspections and the limited resources within the FDA field operations, many of the food firm inspections are contracted out to the States to be performed.

The FDA has an automated Field Accomplishment and Tracking System (FACTS) in which all food firm inspection data is captured and tracked. Currently only FDA employees have access to FACTS; States do not. Consequently, manual processes such as faxes and phone calls are employed to communicate inspection information between the FDA and the States. In an effort to automate some of these processes and to streamline communications between the States and the FDA, the Electronic States Access to FACTS (eSAF) concept was conceived.

eSAF will allow the FDA to automate the issuance of work requests to the State food firm contractors and will allow the State contractors to enter and update inspection results electronically. In addition, the States will have access to the firm data that FDA has maintained in FACTS for the past several years. This data will enable the States to identify firms considered to be "high-risk" and to obtain information about past inspections and violations for firms within their jurisdictional area.

The purpose of this document is to present the requirements associated with eSAF. This document will be used to confirm a common understanding between Booz Allen and the FDA Client Team with regard to the project requirements and as the basis for continued system development. It is understood that this is a working draft document and is not at this time to be construed to be either complete or final. As requirements contained in this document are validated and additional requirements and details are identified, the information will be incorporated into a subsequent version.

August 1, 2002 2

2. ASSUMPTIONS

Requirement / Process Assumption Notes

Overall

FACTS will not be modified as part of the eSAF pilot.

Reporting capabilities will be implemented in a post-pilot time frame.

Data code reference tables (e.g., establishment types) will be maintained in FACTS and values will be validated by eSAF by querying the FACTS code reference tables.

Assignments

The FDA process for creating the work plan and identifying firms to be inspected by the State will be performed outside of eSAF.

The FDA process for scheduling and prioritizing the inspections to be performed by the State are planned outside of eSAF.

FDA District Offices will generate inspection assignments to the States and not to an individual State investigator or inspector.

Individual State inspections requested by the District to the State will be managed, scheduled, prioritized, and assigned by the State outside of eSAF.

State assignments will be generated and issued to the State through eSAF and not through FACTS.

Accomplishment Hours Hours will only be recorded in eSAF for State users. FDA investigator hours will be tracked in FACTS.

FDA investigator will have the capability to track hours in FACTS as part of a future release of the FACTS application.

System Privileges

Any State user can view and modify any inspection of his/her State, based on his/her system privileges, defined as follows:

• Supervisor – Request changes/accept assignments; approve

State inspection data to be submitted to the FDA.

• Data Entry/Editor – Create/update any inspection for the

State.

• Viewer – View data only privilege.

• System Administrator – Manage user accounts and privileges in eSAF.

• District Contract Monitor – Creates/Updates Assignment, Review/Submit State inspection to FACTS.

Every individual eSAF user will have his/her own separate access account. The State can have an unlimited number of eSAF users and the State will determine who will be assigned an account.

August 1, 2002 3

3. PROCESS FLOWS

The business process flows for the eSAF system are depicted in Figures 3.1 - 3.5 on the following pages.

August 1, 2002 4

Figure 3-1. eSAF High-Level Process Flow

1.1 Create/

Update

Assignment

1.3 Review

Assignment &

Related Information

2.1 Prepare for

Inspection

1.2 Issue

Assignment

2.2 Enter/

Update

Inspection Results

2.3 Review/

Submit

Inspection Results

3.1 Review

Inspection

FDA District

State

A ss ig nm en t u pd at e re qu es t

U pd at ed a ss ig nm en t

Reject

1.0 Request State Inspections

2.0 Record Inspection Results

3.0 Review Inspection Results

eSAF

3.2 Finalize

Inspection

Create Workplan

FACTS

Conduct Inspection

State Contract Monitor/Co-Project Officer

Accept

N ew

U pd at e

N ew a ss ig nm en t

Legend:

Shaded, Dashed Symbol

Not part of eSAF

August 1, 2002 5

Figure 3-2. 1.0 Request State Inspections

1.1 Create/Update

Assignment

1.1.1 Create/Update

Assignment

1.3 Review

Assignment &

Related Information

Assignment OK? Yes

No

A

1.2 Issue

Assignment

1.1.2 Create

Inspection Operation

1.1.3 Import List of

Firms and Product List

1.1.4 Review/Edit

Assignment

1.2.1 Issue

Assignment

1.2.2 Retrieve Related

Data from FACTS

1.2.3 Notify State

1.3.1 View Assignment

and Related Information

1.3.2 Accept

Assignment

1.3.3 Request Update

to Assignment

D

Create Workplan FACTS

Legend:

Hatched Symbol

Not in scope for eSAF pilot

Shaded, Dashed Symbol

Not part of eSAF

August 1, 2002 6

Figure 3-3. 2.0 Record Inspection Results

Accept?

2.1 Prepare for

Inspection

2.1.1 Generate

Inspection Sheet

2.3.2 Submit

Inspection Results to

FDA

(Batch)

2.2.1 Enter/Update

Inspection Results

(On-line)

2.3.1 Review Draft

Inspection Results

(On-line)

2.3.3 Submit

Inspection Results to

FDA

(On-line)

2.2 Enter/Update

Inspection Results

2.3 Review/

Submit Inspection

Results

Conduct Inspection

No Yes

A

B

C

Legend:

Shaded, Dashed Symbol

Not part of eSAF

Review Draft Inspection Results

(Batch)

Enter/Update Inspection Results

(Batch) Accept?

No

Yes

August 1, 2002 7

Figure 3-4. 3.0 Review Inspection Results

No

3.1 Review

Inspection

B

3.1.2 Review

Submitted Inspection

Results (On-line)

3.1.1 Review

Submitted Inspection Results (Automated)

3.1.3 Request

Revisions to

Inspection Results

C3.1.4 Notify State

3.2.1 Identify Data to

Update in FACTS

Accept?

Request Compliance

Action?

3.2.5 Update FACTS

Pass Automated Review ?

No

3.2.2 Initiate

Compliance Action

Yes

No

Follow -up?

3.2 Finalize

Inspection

Yes

D

FACTS

Legend:

Shaded, Dashed Symbol

Not part of eSAF

3.2.6 Initiate Follow -Up

3.2.3 Close Inspection

All Inspections Complete?

3.2.4 Close

AssignmentYes

No

End

No

No Yes

Flag Manual

Review ?

August 1, 2002 8

Figure 3-5 2.3.2 Submit Inspection Results to FDA (Batch)

FDA (eSAF)

State

Validate File Structure

Retrieve Inspections Not

Approved by FDA Generate XML File Encrypt File Connect to FDA

FTP Site Send File

Parse XML Syntax

Validate Header

Information

For Each Inspection

Previously Accepted?

Update Required?

Perform Data

Validation

3.1 Review

Inspection

3.2 Finalize

Inspection

Store Data as Submitted

Another Inspection?

Archive File Notify State and FDA

Valid

Valid Valid

Yes

No

No

No Yes

End

Yes

Start

Error

Error

Error

August 1, 2002 9

4. REQUIREMENTS

4.1.1 1.0 Request State Inspections

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

1.1 Create/Update

1. The system shall allow the State Contract Monitors (SCM) /Co- Project Officers to request work only for States within their district.

1.1.1 – Create/Update

2. The system shall allow the SCM to request multiple inspection operations under one assignment.

1.1.1 – Create/Update Assignment

1.1.2 – Create Inspection Operation

3. The system shall allow inspection assignments to be requested as follow up operations to prior inspections or consumer complaints.

1.1.1 – Create/Update

3.2.6 Initiate Follow-Up

4. The system shall allow the SCM to enter/update the following data on an assignment.

• Contract Number

• State

• State Agency

• Subject

• Requester

• Request Date

• Assignment Target Date

• Assignment Priority

• Background Information

• Assignment Status

• Assignment Status Date

• District Point of Contact (POC) Name

• District POC Phone

• District POC Extension

• District POC Email

• Remarks

August 1, 2002 10

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

5. The system shall track the assignments by a unique sequential identifier, i.e., Assignment ID, generated by the system.

6. The system shall provide the capability to duplicate the following information on the assignment when a new assignment is created:

• Contract Number

• State

• State Agency

• Subject

• Requester

• Request Date

• Assignment Target Date

• Assignment Priority

• Assignment Status

• Assignment Status Date

• District Point of Contact (POC) Name

• District POC Phone

• District POC Extension

• District POC Email

1.1.1 – Create/Update Assignment

Yes

7. The system shall allow the FDA Headquarters - Division of Federal State Relations (DFSR) to create an assignment directly for the State/State Agency.

1.1.1 – Create/Update Assignment

Yes

8. The system shall not restrict the SCM to request inspections by Workload Obligation or Operational status.

9. The system shall allow the SCM to request inspections for firms within his/her own district.

10. The system shall alert the SCM if an inspection is requested for a firm that is Out of Business or is not in the Official Establishment Inventory.

11. The system shall allow the SCM to indicate whether the planned inspection is a State audit or an FDA/State joint inspection.

12. The system shall not allow the State audit or FDA/State joint inspection indicator to be updated if the inspection did not result in a joint or audit inspection.

August 1, 2002 11

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

13. The system shall allow the SCM to add the FDA investigator to the inspection, which will then allow the investigator to add his/her time to the State inspection in FACTS. Alternately, the SCM can flag the inspection as a joint inspection, which will allow the investigator within the district to add his/her time.

1.1.2 - Create Inspection Operation

Pending concurrence from the ORA-Division of Planning, Evaluation and Management (DPEM) and ORA-Division of Federal State Relations (DFSR).

Capability will be provided in a future FACTS release. State will flag the inspection as Joint or Audit inspection, which will allow the FDA Investigator to add hours to the inspection in FACTS once the results are transferred to

FACTS.

14. The system shall allow the SCM to specify the following information for each inspection on the assignment:

• OP ID (System generated)

• Operation (Inspection) Status

• Operation (Inspection) Status Date

• Firm to be inspected, i.e., FEI

• Requester Priority

• Target Completion Date

• Inspection Basis (Reason for Inspection)

• Product(s)

• PAC(s)

• Remarks

15. The system shall display the following firm information when the firm FEI is entered/updated on the assignment:

• Firm Name

• Firm Address

• Firm County

• Last Inspection Date

• Last Violative Inspection Date

16. The system shall allow the SCM to enter/update only food-related products when creating an assignment.

17. The system shall allow the SCM to enter/update only State Program PACs that are food related.

August 1, 2002 12

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

18. The system shall allow the SCM to request inspection assignment to the State other than food inspections, i.e., tissue residues, Bovine Spongiform Encephalopathy (BSE), medicated feeds, and medical devices.

1.1.2 – Create Inspection Operation

Yes

19. The system shall allow the SCM to update only those assignments that were generated from within his or her District.

1.1.4 – Review/Edit

20.

The system shall provide the capability for the SCM to add or delete firms from the list sent to the State. A firm shall not be deleted from the list if the State has already begun data entry of the inspection results, i.e., work in progress.

21. The system shall allow the same firm in the assignment to be assigned more than once for re-inspection within the same contract year cycle.

22. The system shall allow the SCM to add inspection operations only to open assignments.

23. The system shall allow the SCM to add/update PACs, products, and firms when the assignments are revised.

24. The system shall prevent State users from adding new inspections to the assignment requested by the SCM.

1.1.4 – Review/Edit Assignment

1.3.3 – Request Update to Assignment

25. The system shall prevent State users from modifying the list of firms on the assignment.

1.1.4 – Review/Edit Assignment

1.3.3 – Request

August 1, 2002 13

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

26. The system shall allow the user to search assignments based on the following search criteria:

• FEI

• Firm Name

• Assignment ID

• Contract Number

• Request Date (Range of Dates)

• Requester Priority

• PACs

• Product

• Status

• Target Date

• City

• County

1.1.1 – Create/Update Assignment

1.1.4 – Review/Edit Assignment

1.3.1 – View Assignment and Related Information

27. The system shall allow the user to search for assignments previously issued by the SCM or returned by the State.

1.1.1 – Create/Update Assignment

1.1.4 – Review/Edit Assignment

1.3.1 – View

28. The system shall allow the user to view a list of assignments and their status.

1.1.4 – Review/Edit Assignment

1.3.1 – View

August 1, 2002 14

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

29. The system shall display the following fields on the assignment list:

• State

• FEI

• Firm Name

• Firm Physical Address

• City

• County

• PAC

• Inspection Date

• Status

• Status Date

1.1.4 – Review/Edit Assignment

1.3.1 – View

30. The system shall allow the user to sort the assignment list by City, County, and Name.

1.1.4 – Review/Edit Assignment

1.3.1 – View

1.2 Issue Assignment

31. The system shall allow the SCM to issue the assignment to the

State after completing his/her edits/revisions and when the assignment is ready to be sent to the State.

1.2.1 – Issue

32. The system shall allow FDA Headquarters-DFSR personnel to issue an assignment to the State.

1.2.1 – Issue Assignment

33.

The system shall allow the SCM to issue more than one assignment to a State agency during a contract year cycle.

1.2.1 – Issue

34. The system shall retrieve firm and related data from FACTS into eSAF such as prior inspections, registrations, consumer complaints, previously completed compliance actions, and products covered corresponding to the firms in the assignment.

1.2.2 – Retrieve Related Data From

FACTS

35. The system shall notify the State Point of Contact via e-mail that the assignment has been issued and can be accessed in eSAF.

1.2.3 – Notify State

August 1, 2002 15

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

1.3 Review

36. The system shall allow State users to view data related to food firms within their State, i.e., firm data, registrations, prior inspections, products covered, consumer complaints, and previously closed compliance actions.

1.3.1 – View

37. The system shall allow State users to view firm data including:

• FEI

• Firm Name

• Firm Physical Address (Street address, City, State, Zip Code)

• Home District

• Area Code, Phone, Extension

• Fax number

• Email Address

• Inspection Responsibility Code

• Legal Status

• Operational Status

• Operational Status Date

• Electronic Signature Certification

• Re-inspection Priority

• Reschedule Inspection Date

• Last Inspection Date

• Last Violative Date

• Firm Postal Address

1.3.1 – View

38. The system shall allow State users to view only food-related firm Establishment Types and Industry Codes.

1.3.1 – View

39. The system shall allow State users to view Firm Points of Contacts. 1.3.1 – View

40. The system shall allow State users to view Firm Cross References. 1.3.1 – View

August 1, 2002 16

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

41. The system shall allow State users to view Low Acid Can Food (LACF) registration data.

1.3.1 – View

42. The system shall provide the State users a view of the consumer complaints including adverse events with “Follow up next Establishment Inspection (EI)” as the final disposition and where the firm has been identified as the Responsible Firm.

1.3.1 – View

43. The system shall allow the State users to view 'Closed' compliance actions pertaining to the firm.

1.3.1 – View

44. The system shall allow State users to view prior inspections performed by the State and prior FDA inspections that have been ‘Completed’.

1.3.1 – View

45.

The system shall display the following fields for view only for prior inspections:

• Inspection Processes

• Reschedule Inspection Date

• Re-inspection Priority

• Inspection Conclusions

• District Decisions

• Inspection Summary

• Endorsement Text

• IB Suggested Actions

• Referral/Distribution list

• 483 Issue?

• 483 Responses

• Related Sample Numbers collected during the inspection

1.3.1 – View

46. The system shall allow State users to view the list of products covered during past inspections.

1.3.1 – View

47. The system shall provide the State users with a view of the FDA Lab Classification and Sample Summary Results for samples collected from past inspections.

1.3.1 – View

48. The system shall restrict data access to the State when data involves personal information, commercial interest, and/or trade secrets.

1.3.1 – View

August 1, 2002 17

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

49. The system shall allow the State user to request changes to the assignment if the firm listed in the assignment is out of business or if the inspection has already been completed.

1.3.3 - Request

August 1, 2002 18

4.1.2 2.0 Record Inspection Results

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

2.1 Prepare for

Inspection

50. The system shall allow State users to log into the system and retrieve firm related data for an assigned inspection.

2.1.1 – Generate Inspection Sheet

51. The system shall allow State users to generate an inspection sheet for the firm to be inspected.

52. The system shall allow the State user to generate inspection sheets one at a time or multiple inspection sheets by selecting multiple firms or all firms from the list.

53. The system shall provide the capability to capture inspection sheets as electronic documents that can be emailed as attachments.

54. The system shall include on the inspection sheet the available information as in the current hardcopy Coversheet, i.e., firm data, products covered, prior inspection data, and firm registration data.

55. The system shall indicate on the inspection sheet that there was a consumer complaint with a final disposition of “Follow up Next EI” that should be covered in the current inspection.

56. The system shall display the endorsement text from the last inspection when generating inspection sheets.

57. The system shall include on the inspection sheet, blank data field columns (i.e., PAC, product-process, products covered), as identified in the hardcopy Coversheet. The investigator while conducting the inspection at the firm site will fill out this information.

2.2 Enter/Update

Inspection Results

58. The system shall allow the designated State user to enter/update inspection results.

2.2.1 – Enter/Update

(On-Line)

59. The system shall allow the State user to only enter/update inspection results for inspections within their State.

2.2.1 – Enter/Update

August 1, 2002 19

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

60. The system shall allow the State user to enter inspection results, inspected processes and conclusions.

2.2.1 – Enter/Update

61.

The system shall allow State users to enter the following fields on the inspection data entry screen:

• FEI

• Firm Name

• Firm Address

• Lead Investigator Name

• Start Date

• Completion Date

• Inspection Processes by PAC, Establishment Type and Product

• Inspection Conclusions

• Products Covered

• 483 Observations Issued?

• Endorsement Text

• Inspection Summary

• Refusals

• Sample Numbers

2.2.1 – Enter/Update Inspection Results (On-Line)

The sample number that is entered is an internal tracking number for the State. A procedure needs to be defined to link State sample numbers to FACTS sample numbers.

62. The system shall allow the State user to enter the State sample number.

2.2.1 – Enter/Update

63. The system shall prevent the State user from entering duplicate inspection results for the same firm based on the FEI and the inspection start date.

2.2.1 – Enter/Update

64. The system shall allow the State user to identify products covered in the inspection.

2.2.1 – Enter/Update

65. The system shall allow the State user to add new products covered during the current inspection.

2.2.1 – Enter/Update

66. The system shall allow the State user to identify products that have been discontinued by the firm.

2.2.1 – Enter/Update

August 1, 2002 20

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

67.

The system shall provide the capability to save the following minimum inspection data:

• FEI

• Inspection Start Date

• At least one Inspection Process (i.e., PAC, establishment type and industry code of the product)

• Lead Investigator performing the inspection

2.2.1 – Enter/Update

68. The system shall not allow the State user to enter the following District information when reporting State inspections:

• Inspection Basis

• District Decisions

• Rescheduled Date

• Reschedule Priority

• IB Suggested Actions

2.2.1 – Enter/Update

69. The system shall allow the user to access the inspection results from the list of assignments.

2.2.1 – Enter/Update

70. The system shall allow the State user to enter inspection results for firms only on the requested assignment.

2.2.1 – Enter/Update

71. The system shall allow State users to enter ad hoc inspection results not under the State contract.

2.2.1 – Enter/Update Inspection Results (On-Line)

72.

The system shall allow the State user to indicate whether the inspection was conducted under:

• State Contract

• Partnership

• Non-contract, i.e., unassigned, State-initiated inspection

2.2.1 – Enter/Update Inspection Results (On-Line)

Yes

73. The system shall allow a State user to update inspection results entered by another State user within the same State.

2.2.1 – Enter/Update

74. The system shall allow the State user to edit inspection results previously entered, but not submitted for FDA approval.

2.2.1 – Enter/Update

August 1, 2002 21

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

75. The system shall allow the State user to correct inspection results based on the State reviewer's comments.

2.2.1 – Enter/Update

76. The system shall allow the State user to correct inspection results based on the SCM's remarks on concurrence.

2.2.1 – Enter/Update

77.

The system shall prevent the State user from modifying an inspection record after the State submits the record to the FDA for review, unless the FDA rejects the record and requests modifications to be made by the State.

2.2.1 – Enter/Update

78. The system shall provide State users the capability to update only those firms that are listed in the assignment requested by the District.

2.2.1 – Enter/Update

79. The system shall allow the State user to update firm data such as legal name and address based on the inspection conducted by the State.

2.2.1 – Enter/Update

80. The system shall use a data management/clean up tool to identify duplicates or incorrect updates to the firm data.

2.2.1 – Enter/Update Inspection Results (On-Line)

Yes

81. The system shall allow the State user to update information related to Firm Points of Contacts.

2.2.1 – Enter/Update

82. The system shall allow the State user to update information related to the Firm Postal Addresses.

2.2.1 – Enter/Update

83. The system shall allow the State user to update firm products covered data only as part of the inspection record.

2.2.1 – Enter/Update

84. The system shall allow State users to identify new firms for the FDA firms database that may be of interest to the FDA.

2.2.1 – Enter/Update Inspection Results (On-Line)

Yes

85. The system shall use a data management tool to validate the new firm data before being added into the FDA firms database.

2.2.1 Enter/Update

Inspection Results (On-Line)

Yes

86. The system shall allow the firm Establishment Types and Industry Codes to be added based on products covered entered in the inspection results upon SCM's concurrence.

2.2.1 – Enter/Update

August 1, 2002 22

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

87. The system shall provide the capability to identify that a firm is out of business.

2.2.1 – Enter/Update

88. The system shall allow the State user to record accomplishment hours for an inspection where the firm is found to be out of business and associate the hours to a domestic investigation rather than to the inspection.

2.2.1 – Enter/Update

89. The system shall provide the capability to enter/update accomplishment hours against PACs, Establishment Type, and Product Process observed during the inspection.

2.2.1 – Enter/Update

90. The system shall provide the capability to track accomplishment hours by FDA Position Class and firm home district.

2.2.1 – Enter/Update

91. The system shall track the accomplishment hours based on the total accomplishment hours spent on the inspected PAC, Establishment Type, and Product Process.

2.2.1 – Enter/Update

92. The system shall track State inspections accomplishment hours by a FDA Position Class defined for the 'State' (STA).

2.2.1 – Enter/Update

93. The system shall perform edits for non-zero accomplishment hours for all PAC and assignees when inspection results are submitted to the State reviewer.

2.2.1 – Enter/Update

94. The system shall require products covered to be entered prior to submitting the inspection results to the State reviewer and based on the establishment type and process-product.

2.2.1 – Enter/Update

August 1, 2002 23

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

95. The system shall track a chronology of the different inspection statuses including:

• Preliminary Results

• Returned to the Investigator

• Forwarded to FDA for concurrence

• Returned to State for correction

• Returned to FDA for concurrence

• Completed/Accepted by FDA

2.2.1 – Enter/Update Inspection Results

2.3.2 – Submit Inspection Results to FDA (Batch)

2.3.3 – Submit Inspection Results to FDA (On-Line)

3.1.1 – Review Submitted Inspection Results (Automated)

3.1.2 – Review Submitted Inspection Results (On-Line)

3.1.3 – Request Revisions to Inspection Results

96. The system shall interface with Turbo – EIR to allow State users to enter and view endorsement text and 483 information.

3.1.2 – Review Submitted Inspection Results (On-Line)

Yes This requirement has been added based on input from Thomas Santucci. This needs to be validated during the post-pilot time frame.

2.3 Review/Submit

(State)

97. The system shall provide the capability to search and view inspection results for the State's review prior to submitting inspection results to the District.

2.3.1 – Review Draft

98. The system shall provide the capability for a State to have an inspection reviewed and updated by a user other than the person who entered the inspection results.

2.3.1 – Review Draft

99. The system shall provide the capability to allow a State to have an inspection submitted to the FDA by a user other than the person who entered the inspection results.

2.3.1 – Review Draft

August 1, 2002 24

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

100. The system shall allow the State reviewer to complete the inspection by endorsing and entering the inspection conclusions and State decisions by PAC and Product.

2.3.1 – Review Draft Inspection Results (On-Line)

This requirement has been modified based on input from DFSR and SCM. The implementation of this requirement for batch data transfer during pilot is to be determined.

101. The system shall allow the State reviewer to enter State decisions by PAC and Product indicating whether the inspection was found in violation (Official Action Indicated (OAI)) and the firm has not performed corrective actions.

2.3.1 – Review Draft

(On-Line)

This requirement has been modified based on input from DFSR and SCM. The implementation of this requirement for batch data transfer during pilot is to be determined.

102. The system shall allow the State reviewer to enter State decisions by PAC and Product when the inspections results are not found to be violative (No Action Indicated (NAI) or Voluntary Action Indicated

(VAI)).

2.3.1 – Review Draft Inspection Results (On-Line)

This requirement has been modified based on input from DFSR and SCM. The implementation of this requirement for batch data transfer during pilot is to be determined.

103. The system shall allow the State reviewer to forward inspection results to the SCM for their concurrence.

2.3.2 – Submit Inspection Results to FDA (Batch)

2.3.3 – Submit Inspection Results to FDA (On-Line)

104.

The system shall flag the State violative inspections results for the SCM to review.

2.3.2 – Submit Inspection Results to FDA (Batch)

2.3.3 – Submit

FDA (On-Line)

105. The system shall notify the State and FDA via e-mail that an inspection submitted via batch has been returned to the State for correction(s).

2.3.2 – Submit

FDA (Batch)

August 1, 2002 25

4.1.3 3.0 Review Inspection Results (FDA)

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

3.1 Review

Inspections

106. The system shall require the SCM to review a percentage of inspections forwarded by the State. This percentage will include inspections flagged for automatic review.

3.1.1 – Review Submitted Inspection Results (Automated)

This requirement has changed based on input from DFSR and

SCM.

107. The system shall allow the SCM to set the percentage of inspections forwarded by the State for review.

3.1.1 – Review Submitted Inspection Results (Automated)

Yes This requirement has been added based on input from DFSR and

SCM.

108. The system shall reject inspection results that do not meet the batch data file specifications, data field formats, and minimum data/edit requirements.

3.1.1 – Review Submitted Inspection Results (Automated)

109. The system shall require accomplishment hours to be entered for all PAC codes and assignees when inspection results are submitted through the batch file.

3.1.1 – Review

Results (Automated)

110. The system shall perform same FACTS firm edit validations when accepting firm updates reported by the State.

3.1.1 – Review Submitted Inspection Results (Automated)

3.1.2 – Review

Results (On-Line)

111. The system shall reject the firm changes and return the report to the State for corrections when the data does not meet the minimum data requirements.

3.1.1 – Review Submitted Inspection Results (Automated)

3.1.2 – Review

112. The system shall require the SCM to review State inspection results where the firm name or address has been changed, or the firm has been set to Out of Business (OOB).

3.1.1 – Review Submitted Inspection Results (Automated)

3.1.2 – Review

113. The system shall notify the SCM of inspection results submitted through the batch file or online process that requires FDA's concurrence.

3.1.2 – Review Submitted Inspection Results (Online)

Business rules need to be defined with FDA.

August 1, 2002 26

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

114. The system shall send a “reminder” notification, after 5 business days, to the SCM of inspection results submitted through the batch file or online process that requires FDA's concurrence that have not been reviewed.

3.1.2 – Review Submitted Inspection Results (Online)

This requirement was added based on input from DFSR and

SCM.

115. The system shall require the SCM to review violative inspection results submitted by the State.

3.1.2 – Review

Results (Online)

116. The system shall require the SCM to review violative inspections for which the State has initiated regulatory action against the firm (i.e., Official Action Indicated (OAI)).

3.1.2 – Review

117. The system shall require the SCM to review State inspection results where the firm establishment types and industry codes have been added based on the products covered during the inspection.

3.1.2 – Review Submitted Inspection Results (Online)

This requirement has been withdrawn based on input from DFSR and SCM.

118. The system shall alert the SCM when the State submits ad hoc, unassigned, non-contract inspection results, and/or new firm information.

3.1.2 – Review Submitted Inspection Results (Online)

Yes

119. The system shall allow the SCM to view the approved inspection record and concur with the results or return it for corrections and additions.

3.1.2 – Review Submitted Inspection Results (On-Line)

3.1.3 – Request

120. The system shall retain the SCM's remarks until the inspection status is changed to ‘Completed’, i.e., Accepted by FDA.

3.1.2 – Review

121. The system shall notify the State of inspection results that have not been corrected or submitted to FDA after the 15 days of the inspection completion date, in accordance with the State contract.

3.1.2 – Review

122. The system shall default the inspection basis as 'Surveillance' and allow it to be changed to 'Compliance' by the SCM at the time of entering the operation.

3.1.2 – Review

123. The system shall provide the capability for the SCM to identify the changes made to the firm information with the capability to accept or reject the changes, or selectively apply the changes.

3.1.2 – Review

August 1, 2002 27

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

124. The system shall allow the SCM to enter remarks indicating the corrections to be made in the inspection and the reasons for not concurring with the results.

3.1.3 – Request

125. The system shall automatically flag and return to the State the inspections submitted by the batch process that have failed edits and validations performed by the system.

3.1.3 – Request Revisions to Inspection Results

Business rules need to be defined by FDA.

126. The system shall notify the State via e-mail that the inspection has been returned to the State for correction.

3.1.4 Notify State

3.2 Finalize

Inspection

127. The system shall allow the SCM to recommend compliance actions and generate compliance work for the District.

3.2.2 – Initiate Compliance Action

This capability is available in the FACTS application.

128. The system shall allow the SCM to release the results of an inspection that have been reviewed and approve by him/her.

3.2.5 – Update FACTS Data

129. The system shall transfer to the FACTS database all inspection results that have been approved and concurred by the SCM.

130. The system shall transfer to the FACTS database all firm updates and inspection results that does not require the SCM's review after all system edit validations are passed.

131. The system shall update the firm establishment types and industry codes based on the products covered entered in the inspection results after SCM concurrence.

3.2.5 – Update FACTS

132. The system shall perform the same FACTS edits for creating firm history records and for generating notifications to OEI coordinators when changes are accepted by the SCM.

133. The system shall allow the SCM to cancel unaccomplished inspections by canceling one at a time, selecting multiple inspections to cancel, or prompt them to cancel all when trying to 'Close' the entire assignment.

3.2.3 – Close Inspection

3.2.4 – Close

134. The system shall allow the SCM to close out assignments after all operations are completed, canceled, or unaccomplished.

135. The system shall allow the SCM to close out only those assignments that were generated from within their district.

136. At the end of the contract year, the system shall allow the SCM to close the assignment, alerting him/her of the unaccomplished pending inspections.

August 1, 2002 28

Req. # Requirement Description eSAF Process Number

Post-Pilot Requirement

Comments/Notes

137. The system shall allow the SCM to automatically cancel all unaccomplished remaining inspections if the SCM chooses to close the assignment.

Batch Transmission and Reporting Requirements

138. The system shall be designed to import data from the State databases into eSAF, if data elements can be identified and mapped.

2.3.2 – Submit

FDA (Batch)

139. The management-reporting tool shall be IQ Solutions. This tool will be made available to the States based on request.

N/A Yes Requirement no longer applies.

Need to identify a reporting tool, which will be implemented in a post-pilot time frame.

Security Requirements

140. The system shall be designed so that the State users will be able to access data only for their State.

N/A