{"text_format":"1","workbook":"xlsx","n_sheets":9,"sheets":["Changes","Instructions","Audit References","Responder Information","Response Message","Responder 3911s","TI Response Additional Info","Response for Req Line 01","Lookup Tables"],"not_rendered":{"charts":0,"images":0,"macros":1,"external_links":0,"defined_names":2,"comments":2,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900"}

{"sheet":"Changes","index":0,"n_rows":5,"n_cols":4,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
["PDG Trace - TI Response"]
["Change Log"]
[]
["Template Version","Date","Changes","Notes"]
["v2.0.0"," ","Initial draft of Trace Response."]

{"sheet":"Instructions","index":1,"n_rows":84,"n_cols":2,"rows_kept":84,"cut":false,"hidden":false,"merged":[]}
["PDG Trace - TI Response"]
["Instructions"]
["How to use this template."]
["TI Response Template Version Number","02.00.00"]
[]
[null,"PDG makes no representations or warranties regarding the accuracy, completeness, or suitability of the information contained in this template. This template is provided “as is” without any guarantees or warranties of any kind, either express or implied. Users are advised to independently evaluate and verify the information before relying on it for any purpose. PDG shall not be held liable for any errors, omissions, or any outcomes resulting from the use of this template.\n\nAll intellectual property rights in and to this template document are owned by PDG. Users are granted a limited, non-exclusive, non-transferable license to use this template for business purposes only. Any unauthorized use or reproduction of this template, in whole or in part, is strictly prohibited."]
[]
[null,"Overview"]
[null,"This workbook supports the pharmaceutical supply chain’s DSCSA conformance by managing responses to traceability requests. Each worksheet plays a distinct role in documenting the response, responder details, and traceability information. Use this guide to navigate the workbook effectively."]
[]
[null,"This guide ensures that you use the DSCSA Trace Response Workbook correctly and efficiently. For further assistance, refer to the Instructions sheet or contact your DSCSA compliance officer."]
[]
[null,"Workbook Contents and Usage"]
[null,"1. Changes"]
[null,"Logs the changes and version history of the workbook."]
[null,"No user input required."]
[null,"Purpose: Track modifications for transparency and auditing."]
[null,"2. Instructions"]
[null,"Detailed instructions for completing the workbook."]
[null,"Recommendation: Review this section before making entries to ensure compliance with DSCSA traceability standards."]
[null,"No user input required."]
[null,"3. Audit References"]
[null,"Stores audit trail details related to the response."]
[null,"How to fill:"]
[null,"1. Enter the relevant audit reference numbers."]
[null,"2. Provide any other audit information required for tracking purposes."]
[null,"Purpose: Maintain a clear audit history."]
[null,"4. Responder Information"]
[null,"Collects details about the entity responding to the trace request."]
[null,"How to fill:"]
[null,"1. Enter the responder's name, contact details, and organization."]
[null,"2. Include any role-specific information."]
[null,"Purpose: Identify the responder for traceability and communication."]
[null,"5. Response Message"]
[null,"Documents the message sent as a response to the trace request."]
[null,"How to fill:"]
[null,"1. Provide a summary of the response message."]
[null,"2. Include any reference numbers or codes related to the response."]
[null,"Purpose: Ensure clear communication and message tracking."]
[null,"6. Responder 3911s"]
[null,"Captures DSCSA-related FDA Form 3911 information, if applicable."]
[null,"How to fill:"]
[null,"1. Provide the relevant 3911 form details, such as submission ID."]
[null,"2. Record any additional notes about the submission."]
[null,"Purpose: Ensure compliance with FDA reporting requirements."]
[null,"7. TI Response Additional Info"]
[null,"Allows for the inclusion of any supplementary information regarding the response."]
[null,"How to fill:"]
[null,"Add any extra context or notes that may help explain or supplement the response."]
[null,"Purpose: Provide additional clarity and context."]
[null,"8 Response for Req Line 01"]
[null,"The primary sheet for documenting responses to each individual trace request line."]
[null,"How to fill:"]
[null,"1. Enter the product identifier (e.g., NDC or GTIN) and transaction information."]
[null,"2. Provide lot numbers, transaction dates, and other relevant details."]
[null,"3. Update the status of the response (Pending, Completed, etc.)."]
[null,"Purpose: Track each trace request line with relevant response details."]
[null,"9. Lookup Tables"]
[null,"Contains predefined values to simplify data entry (e.g., product codes, status options)."]
[null,"Recommendation: Use these values to ensure consistency and avoid errors."]
[null,"No user input required unless adding new lookup entries."]
[]
[null,"Steps to Use the Workbook"]
[null,"1. Start with Instructions:"]
[null,"Read the Instructions sheet to familiarize yourself with the process."]
[null,"2. Fill Responder Information:"]
[null,"Enter your contact and organization details in the Responder Information sheet."]
[null,"3. Complete the Response Message:"]
[null,"Document the response message in the Response Message sheet."]
[null,"4. Include FDA 3911 Data (If Needed):"]
[null,"Fill out the Responder 3911s section if there is a need to report using FDA Form 3911."]
[null,"5. Respond to Individual Request Lines:"]
[null,"Use the Response for Req Line 01 sheet to provide detailed responses for each trace request."]
[null,"6. Add Supplementary Info:"]
[null,"Use TI Response Additional Info for any additional information or notes."]
[null,"7. Leverage Lookup Tables:"]
[null,"Utilize predefined values from the Lookup Tables to ensure accuracy and avoid data entry errors."]
[null,"8. Maintain an Audit Trail:"]
[null,"Record relevant audit information in the Audit References sheet."]
[]
[null,"Tips for Effective Use"]
[null,"Use Lookup Tables: Always refer to the Lookup Tables to maintain consistency."]
[null,"Track Changes: Regularly update the status in the Response for Req Line 01 sheet to reflect current progress."]
[null,"Provide Clear Documentation: Ensure your response message and additional info are thorough to minimize follow-ups."]

{"sheet":"Audit References","index":2,"n_rows":12,"n_cols":3,"rows_kept":12,"cut":false,"hidden":false,"merged":[]}
["PDG Trace - TI Response"]
["TI Response Audit References"]
[]
["Trace Response Template Version:","01.00.00"]
[]
["TI Response ID*:",null,"Use a Universally Unique ID "]
[]
["TI Request ID:"]
[]
["TI Request Investigation ID:"]
[]
["TI Response Timestamp*:","2024-10-15T14:27:16"]

{"sheet":"Responder Information","index":3,"n_rows":21,"n_cols":1,"rows_kept":21,"cut":false,"hidden":false,"merged":[]}
["PDG Trace - TI Response"]
["Responding Party"]
[]
[]
["Contact Information:"]
[]
["Person or Department Name*:"]
[]
["Organization Name*:"]
[]
["Phone*:"]
[]
["Email*:"]
[]
["Responder GLN:"]
[]
["Callback Address*:"]
[]
["Email Callback Address:"]
[]
["API Callback Address:"]

{"sheet":"Response Message","index":4,"n_rows":2,"n_cols":1,"rows_kept":2,"cut":false,"hidden":false,"merged":[]}
["PDG Trace - TI Response"]
["Response Message"]

{"sheet":"Responder 3911s","index":5,"n_rows":4,"n_cols":1,"rows_kept":4,"cut":false,"hidden":false,"merged":[]}
["PDG Trace - TI Response"]
["Known 3911s associated with the requested products"]
[]
[3911]

{"sheet":"TI Response Additional Info","index":6,"n_rows":9,"n_cols":2,"rows_kept":9,"cut":false,"hidden":false,"merged":[]}
["PDG Trace - TI Response"]
["Additional Information","(provide links or attach additional documents)"]
[]
[]
["Links"]
[]
[]
[]
["Attached Document Name"]

{"sheet":"Response for Req Line 01","index":7,"n_rows":49,"n_cols":44,"rows_kept":49,"cut":false,"hidden":false,"merged":[[16,33,16,42],[36,3,36,9],[48,0,48,5],[36,0,36,2],[36,10,36,11],[35,0,35,14],[12,2,12,5],[15,0,15,5],[16,0,16,6],[16,7,16,9],[16,31,16,32],[16,10,16,14],[16,15,16,21],[16,22,16,23],[16,24,16,30],[49,0,49,1],[50,0,50,1],[51,0,51,1],[52,0,52,1],[53,0,53,1]]}
["PDG Trace - TI Response","Repeat this sheet for each Line Number on the Request"]
["TI Response"]
[]
["Request Line Number*:",null,1]
[]
["Product ID*:","GTIN:"]
[null,"NDC:"]
[]
[" ","Serial or Lot Number:"]
[]
["Response Type Requested*:"]
[]
["Request Line Number Message:"]
[]
[]
["Transaction Information (fill in if Requester requested Transaction Information)"]
["Product Information",null,null,null,null,null,null,"Product Production Information",null,null,"Transaction Data",null,null,null,null,"Ownership From Information",null,null,null,null,null,null,"Connectivity Information",null,"Ownership To Information",null,null,null,null,null,null,"Connectivity Information",null,"Drop Ship Information (drop ship indicator and Ship To information)"]
["GTIN","NDC","Drug Name","Strength","Dosage Form","Container Size","Number of Containers","Lot Number","Serial Number","Expiration Date","Associated PO","Transaction Statement","Direct Purchase Statement","Date of Shipment","Date of Transaction","GLN ","Company Name","Street Address","City","State ","Postal Code","Country Code","TI Request email Address","TI Request URI Address","GLN ","Company Name","Street Address","City","State ","Postal Code","Country Code","TI Request email Address","TI Request URI Address","Dropship Indicator","GLN ","Company Name","Street Address","City","State ","Postal Code","Country Code","TI Request email Address","TI Request URI Address","Notes"]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
["Ownership Information (fill in if Requester requested All Known or Last Known Owners)"]
["Product & Transaction Information",null,null,"Known Owner Information",null,null,null,null,null,null,"Connectivity Information"]
["GTIN","NDC","Serial Number","Owner GLN ","Owner Company Name","Street Address","City","State ","Postal Code","Country Code","TI Request email Address","TI Request URI Address","Notes"]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
["Line Item Additional Information (If you attached documents with this response, add those document names here)"]

{"sheet":"Lookup Tables","index":8,"n_rows":8,"n_cols":2,"rows_kept":8,"cut":false,"hidden":false,"merged":[]}
["PDG Trace - TI Response"]
["Lookup Tables"]
[]
[null,"Response Type List"]
[]
[null,"Transaction Information"]
[null,"All Known Owners"]
[null,"Last Known Owner"]