Validation requirement after moving labeling data base to different drive

S

shala

#1
#1
Hello

We want to move our Label Database System after moving the operating files from one network drive to the other network drive, what should be validated for this case?
I would be very appreciate on your help in this matter.
 
Download Free White Paper
Elsmar Forum Sponsor
S

shala

#3
#3
Labeling being used for IVD devices. we are using this system for long time and now we want to move this system to other network drive. our labeling software is Microsoft access database program.
we want to validate functionality of labeling system after moving to new drive.
 
Jen Kirley

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#4
#4
I would validate using a short test with data that is likely to be needed. If there are multiple sectors or otherwise chunks of data that could become lost, I would outline them and validate all of them if possible.
 
S

shala

#5
#5
Thanks for reply. Do you think printing labels and comparing the similarity with original one and scanning barcode for checking accuracy for all labels type is enough?
do I need to repeat validation of computer or barcode scanner too?
 
Marc

Marc

Fully vaccinated are you?
Leader
Admin
#6
#6
I would think so. Just moving the database to a new drive shouldn't affect the database. The part that will be important is that the program that uses the database for inputs and outputs is reconfigured to point to the new database location.

As Jennifer said, do a short run of labels. Then use your barcode scanner to read them. You'll be validating the database, the barcode scanner and the computer all at the same time. I would also include input, though - Make a new label, print it and then scan it.
 
M

MIREGMGR

#7
#7
Technically, creating a particular label and checking it is verification. To validate a system for which there is no overriding rule or guidance that allows you to do less, you must test in such a way that you've established that the system works correctly with all of the potential variables exercised across their full ranges, and with any interactions among variables investigated.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Requirement for manufacturing process validation in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 8
S Requirement for Sterilization Validation completion before issuance of ISO cert ISO 13485:2016 - Medical Device Quality Management Systems 0
N ETO Sterilisation Validation - EO Residual Minimum Sample Requirement ISO 13485:2016 - Medical Device Quality Management Systems 2
S Sterilization Validation Accreditation - A mandated standard requirement? ISO 13485:2016 - Medical Device Quality Management Systems 5
C Software Validation Procedure per FDA requirement Qualification and Validation (including 21 CFR Part 11) 3
I CNC Machine Validation Requirement ISO 13485:2016 - Medical Device Quality Management Systems 20
I AS9100B Cl 7.5.1.3 - How to comply with validation of production tools requirement? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
H EU Validation Requirement vs. FDA Validation Requirement - EN 62304 IEC 62304 - Medical Device Software Life Cycle Processes 16
C Meeting Validation of Process Requirement - Stainless steel pipe & tube manufacturer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Manix GM Requirement for Trim Clip Validation - Anyone know a specification number Customer and Company Specific Requirements 4
A Validation of Processes - How to meet requirement of TS 16949 para. 7.5.2.1? IATF 16949 - Automotive Quality Systems Standard 12
R System Requirement - FDA - Software Validation on various OSs ISO 13485:2016 - Medical Device Quality Management Systems 13
J 7.5.2.1 Validation of processes - supplemental requirement IATF 16949 - Automotive Quality Systems Standard 11
B Transport Validation For Non-sterile Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
D Software Validation Question ISO 13485:2016 - Medical Device Quality Management Systems 10
G Pad Printing Validation OR Verification ISO 13485:2016 - Medical Device Quality Management Systems 4
A ETHYLENE OXIDE STERILIZATION VALIDATION Manufacturing and Related Processes 4
C. Tejeda Computer system validation approach for Minitab Statistical software Software Quality Assurance 7
D 8.5.1.2 Validation and control of special processes requirements for Heat Treat External Processor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Performance Qualification and Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
L ISO 11607-1 Packaging system validation Design and Development of Products and Processes 6
John C. Abnet ...validation of computer software ISO 13485:2016 - Medical Device Quality Management Systems 14
D Machine rebuilds versus process re-validation IATF 16949 - Automotive Quality Systems Standard 1
R Cloud-based SaMD Validation IEC 62304 - Medical Device Software Life Cycle Processes 8
G Process Validation Before/After Sterilization? Design and Development of Products and Processes 3
D Laboratory Refrigerator Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
T SQL Server 2019 - Master Data Services - Validation needed? ISO 13485:2016 - Medical Device Quality Management Systems 4
G Shipping Validation of Non-Sterile Parts? Other Medical Device and Orthopedic Related Topics 9
J Hardware Validation Qualification and Validation (including 21 CFR Part 11) 1
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
blackholequasar Validation of new ERP system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G How to Record Informal Testing (Not Verification/Validation) Other Medical Device and Orthopedic Related Topics 15
B Clean room shut down and re-validation or re-qualification? Other Medical Device Related Standards 6
B Vision system process validation Manufacturing and Related Processes 1
R Validation of Software used in Verification Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
D Glassware cleaning validation Qualification and Validation (including 21 CFR Part 11) 3
M Do i need to have equipment validation if 100% testing is completed? Qualification and Validation (including 21 CFR Part 11) 6
R SaMD Verification & Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
B SPECIAL PROCESS VALIDATION & REVALIDATION Qualification and Validation (including 21 CFR Part 11) 4
R Validation of processes Oil and Gas Industry Standards and Regulations 2
L Guidance for validation - mixing homogeneity Qualification and Validation (including 21 CFR Part 11) 0
E DESIGN VALIDATION, USABILITY AND CLINICAL EVALUATION request Medical Device and FDA Regulations and Standards News 0
S In Field Validation Requirements Other Medical Device Related Standards 1
L Validation of mixers Capability, Accuracy and Stability - Processes, Machines, etc. 2
L Validation of mixers Qualification and Validation (including 21 CFR Part 11) 0
B How to satisfy clause 5.7.1.5 process validation for valve production API 6D Oil and Gas Industry Standards and Regulations 13
A Applying agile model for Computer system Validation Medical Device and FDA Regulations and Standards News 3
H Production Validation- CE Mark ISO 13485:2016 - Medical Device Quality Management Systems 3
Watchcat Software validation vs design V&V? Other US Medical Device Regulations 27
M Initial Importer/Distributor and Software Validation IEC 62304 - Medical Device Software Life Cycle Processes 1

Similar threads

Top Bottom