SBS - The best value in QMS software

Software Validation for FFS Packaging Machine

#1
Hi Everyone!

Its a startup medical device company and we have established our own manufacturing. We are going to have a FFS packaging machine in our production floor. The issue is how do we able to know to what extend we require to do a software validation for the packaging machine. Is the software validation certificate from the manufacturer sufficient for us? do we really need to come out with protocol and do the software validation as per ISO 13485:2016. if there is anyone who able to share with us any example or template it is greatly appreciated.


Thanks in advance!
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
A bit short on information to give much guidance here. Such validations should be commensurate with the risk. What are the risks (in terms of risk to patients / users, environment or regulatory compliance) if the software fails? Then, what are the requirements for the software for your intended use? And don't just consider functional; consider aspects like security and, if applicable, Part 11.

I would expect that this is not your only software application that should be validated. You should probably consider establishing a Master Validation Plan to establish the basis for your risk-based approach.
 
Thread starter Similar threads Forum Replies Date
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 8
D Software validation in Medical Equipment Other Medical Device and Orthopedic Related Topics 20
C Looking for simple Software Validation IQ templates. Qualification and Validation (including 21 CFR Part 11) 4
C Software validation - Off The Shelf Software - Web hosted ISO 13485:2016 - Medical Device Quality Management Systems 6
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
F 21 CFR Part 11 - Implicit requirements - Validation plan for a Software as a Service Other US Medical Device Regulations 1
R ISO 13485 Software validation procedure and Quality Objectives Monitoring wanted Document Control Systems, Procedures, Forms and Templates 1
S Validation of COTS Equipment plus Software Qualification and Validation (including 21 CFR Part 11) 12
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
Pmarszal Software Validation Training Course - Recommendations Training - Internal, External, Online and Distance Learning 3
T Software Validation Certificate (ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 19
R FDA Requirements - Printing Equipment Software Validation Qualification and Validation (including 21 CFR Part 11) 1
G Windows 10 OS build Software Validation US Food and Drug Administration (FDA) 1
S Where to keep Enterprise Resource Planning software (ERP) Validation Records ISO 13485:2016 - Medical Device Quality Management Systems 1
C Software validation (4.1.6 ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 20
M Software Validation Guidance Suggestions Various Other Specifications, Standards, and related Requirements 6
S QMS software validation - Documentation ISO 13485:2016 - Medical Device Quality Management Systems 5
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
R CNC Software Validation requirements as per ISO 13485:2016 Other ISO and International Standards and European Regulations 8
R Software validation - off the shelf X-Ray Software Quality Assurance 3
S What is the clause in ISO 13485 for SAP Software Validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Software validation of Data Exporter ISO 13485:2016 - Medical Device Quality Management Systems 3
A Process Validation of QMS Software ISO 13485: 2016 Cl. 4.1.6 ISO 13485:2016 - Medical Device Quality Management Systems 26
P Software Validation for Equipment - Question ISO 13485:2016 - Medical Device Quality Management Systems 5
D Medical Device Software Tool Validation - Compilers! IEC 62304 - Medical Device Software Life Cycle Processes 7
N When is Medical Device Software Validation required? ISO 13485:2016 - Medical Device Quality Management Systems 6
O Process Mapping prior to Validation and Software to use to Map Process Maps, Process Mapping and Turtle Diagrams 12
S Software Validation – Clause 4.1.6 of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 12
B Could I combine IQ, OQ and PQ for Minitab Software Validation ? Software Quality Assurance 3
R Document Management Software : Validation and other requirements Medical Information Technology, Medical Software and Health Informatics 8
E Software Validation - Clinical Trials US Food and Drug Administration (FDA) 3
K What are the minimum requirements for Process Validation (Software)? ISO 13485:2016 - Medical Device Quality Management Systems 5
R ISO - Clause 7.5.1.3 - CMM Software Program Validation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
I Validation Software Experience? (Valgenesis, etc.) Quality Assurance and Compliance Software Tools and Solutions 1
M Injection Molding Machine Software Validation Calibration and Metrology Software and Hardware 2
E FDA Requirements for Implantable Medical Device Software Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
C Change Control Forms Post Software Validation Medical Information Technology, Medical Software and Health Informatics 2
C Thoughts on validation of Legacy Systems for Medical Device Software EU Medical Device Regulations 2
C Cement Mixing Software Validation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Y OTS (Off The Shelf) Software Validation for 510k Traditional 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V Validation of macro - scripts - programs used in statistical software (Minitab-SAS... Qualification and Validation (including 21 CFR Part 11) 5
R ISO 13485 Software Validation Requirements - Help needed ISO 13485:2016 - Medical Device Quality Management Systems 4
M MSA - Validation of Metrology Software such as PCDMIS Calibration and Metrology Software and Hardware 2

Similar threads

Top Bottom