Validation Strategy for Changes to ISBT 128 Terminology
This validation strategy is intended for facilities that:
· Have already implemented ISBT 128 labeling and are seeking to validate only the changes to the terminology, OR
· Have implemented ISBT 128 terminology (not full labeling) and are seeking to validate only the changes to the terminology.
1. Depending on the original validation that a facility performed, explain in the introduction to the validation why this simple approach to validating only the changes to terminology is being used. The robustness of the original validation, the history with the system,and any issues encountered previously should be considered.
2. Follow internal procedures for validation and change control. Please note that internal policies and procedures may require additional testing beyond that contained in this document.
3. Determine a “Must Use Date” for new terminology in your facility. (Database and terminology were changed by ICCBBA effective Aug 15, 2013.)
4. Maintain/archive existing terminology that was used in the past, but do not use after the Must Use Date for the new descriptions in your facility.
5. Use new descriptions/terminology after the Must Use Date.
6. General approach to validation:
a. Update software as appropriate (or use a vendor-supplied software version that utilizes the new descriptions in the ICCBBA Product Code database version 4.26.0 or after).
b. Review the Crosswalk Attachment from the document IMPLEMENTATION GUIDE, Revised Cellular Therapy Terminology, Version 1.0.0 August 2013, Tracking Number ICCBBA IG-036, published by ICCBBA, PO Box 11309, San Bernardino, CA 92423-1309 USA.
c. Determine how many Product Description Codes from the “Old Code” column in the table are being used by your facility and list or highlight these codes.
d. For each code used by your facility, validate that correct labels are generated. This will be done by creating a label for each Product Description Code used and validating that the information is printed correctly.
e. For those using automated systems to scan labels: Validate that the system can read and interpret bar codes on the labels correctly. This will be done by printing a label for each Product Description Code used and validating that when scanned, the bar codes were read and interpreted correctly.
Validation Plan
Part 1: Printing Labels
This part should be performed by facilities that use ISBT 128 terminology, regardless of whether they use ISBT 128 bar codes.
Create a Test Execution and Review Worksheet: Create a table that includes space for:
· The Product Description Codes (or product names if using terminology only), both active and retired, for all products that you make
· Application of the printed label
· Pass or Fail interpretation
· Initials
· Date
Include fields at the bottom of each page for reviewer initials and review date.
Example Test Execution and Review Worksheet for printing of labels:
Product Codes Used (or products produced if terminology only) / Printed Label / Pass or Fail / Tester’s Initials / Test Date1. Print a label for each Product Description Code (or for each product if using only terminology).
2. Attach the label to the worksheet.
3. Use IMPLEMENTATION GUIDE, Revised Cellular Therapy Terminology, Version 1.0.0, August 2013, Tracking Number ICCBBA IG-036, Published by ICCBBA, PO Box 11309, San Bernardino, CA 92423-1309 USA.
a. For facilities using full ISBT 128 labeling: Use IG-036 Crosswalk Attachment and verify the Class name and description on the label matches the new Class name and description in the Crosswalk and that the Attributes are printed in the desired order. This may vary by country but in general will be in the order shown on the Crosswalk.
b. For facilities using ISBT 128 terminology only: Use Table 1 in IMPLEMENTATION GUIDE, Revised Cellular Therapy Terminology, and verify the product name on the label matches the name in the “New Class Name” column.
4. Record interpretation (pass or fail), initial, and date each label on the worksheet.
5. Have a second person review the printed label and compare it to the Crosswalk. Reviewer should date and initial each page after reviewing it, providing all tests on that page pass.
6. If any label Class name or description fails, notify your software vendor.
7. Post Implementation Testing: For a period determined by the facility, audit all labels produced and verify correct information is printed by comparing to information in IMPLEMENTATION GUIDE, Revised Cellular Therapy Terminology, Version 1.0.0 August 2013, Tracking Number ICCBBA IG-036, Published by: ICCBBA PO Box 11309, San Bernardino, CA 92423-1309 USA.
Part 2: Reading and Interpreting Labels
This section should be performed if the facility’s computer system reads and interprets ISBT 128 bar codes.
1. Utilizing the labels created in Part 1, scan bar codes on labels.
a. Print computer screen displaying label information.
b. Review printouts and verify bar codes were scanned and interpreted as expected (matched printed label information).
2. If no retired codes were included in Part 1, use old version software (from database version 4.25.0 or earlier) to create 5 different labels for product codes that were retired with database version 4.26.0 (e.g., S1470). If some of the Product Description Codes your facility previously used have been retired, these would be good codes to select.
a. Scan these labels and print computer screen displaying label information. Review screen print.
b. Compare against Crosswalk table from IG-036. Verify that all information matches the label EXCEPT that product description should match information in IG-036 Crosswalk table “New Description” column rather than what is printed on the label. (Label should match “Old Description” column from Crosswalk table).
3. Tester will date and initial each page after reviewing.
4. Reviewer will date and initial each page after reviewing, provided all tests on that page pass.
5. If any label fails to be scanned and interpreted correctly, identify if the problem is within the label software (i.e., the bar code was printed correctly) or within the system interpreting the label. Notify the appropriate software vendor.
Approve Plan by subject matter expert. Printed name, title, signature, date.
Approve Plan by Quality Assurance. Printed name, title, signature, date.
Validation Report
1. Refer to validation plan by document number and title.
2. Identify the tester(s) by name(s) and title(s).
3. Identify the reviewer(s) by name(s) and title(s)
4. Identify any failed tests, corrective actions, and repeated tests.
5. Make a statement similar to this: All codes in use at this facility have the correct new descriptions as shown by the test results on the attached Test Execution and Review Worksheet.
Approve Report by subject matter expert. Printed name, title, signature, date.
Approve Report by Quality Assurance. Printed name, title, signature, date.
For questions about this plan or the new terminology, please contact .
Acknowledgement
ICCBBA wishes to thank David Nettleton for his contributions to this document.
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA compliant applications. His most popular book is Risk Based Software Validation - Ten Easy Steps (Davis Horwood International and PDA - www.pda.org, 2006), which provides fill-in-the-blank templates for completing a COTS software validation project. He has completed more than 238 mission critical laboratory, clinical, and manufacturing software implementation projects.
Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory audits: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.
Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.
David Nettleton is also the co-author of:
Managing the Documentation Maze – Answers to Questions You Didn’t Even Know to Ask (Wiley – www.wiley.com) 2010;
Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com, 2004);
Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org, 2003).
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