Medical Device Process validation, Validation of excel spreadsheets used for process

M

MattChallenger

#1
Hi

I have been trying to figure out the depths i should delve into excel spreadsheet validation.

I want to know if I should be validating the excel spreadsheets that we used to conduct process validation.
This seems like a never ending exercise, however the risk to process and design validation if these spreadsheets are not validated is of course very high.

Any thoughts or advice would be amazing.

Matt
 
Elsmar Forum Sponsor
#2
Re: Medical Device- Process validation, Validation of excel spreadsheets used for pro

Hi Matt,

Welcome to the forums.

I recall that we had a previous discussion on spreadsheet validation, here:-
Software Validation – Clause 4.1.6 of ISO 13485:2016

That thread has a bunch of links to informative sites.
And the clear consensus that you do not have to validate the underlying software - it is your functions / macros / formulae that require validation.
 

Marcelo

Inactive Registered Visitor
#3
Re: Medical Device- Process validation, Validation of excel spreadsheets used for pro

Please note that the validation of the excel spreadsheets is an application of software validation inside the process validation. See, for example, IEC 80002-2, which includes examples.
 
Thread starter Similar threads Forum Replies Date
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 4
S FDA approval process for medical device US Food and Drug Administration (FDA) 2
V Tyvek packaging for Medical device process validation Qualification and Validation (including 21 CFR Part 11) 2
shimonv The regulatory process for registering a Medical Device in India Other Medical Device Regulations World-Wide 2
A Medical Device Licensing - Plans or Process Maps Other US Medical Device Regulations 3
P Approval process for modifications to a medical device with a CE Mark CE Marking (Conformité Européene) / CB Scheme 5
L Medical Device New Product Design & Development- How long does this process take you? Other Medical Device and Orthopedic Related Topics 1
D Canada Medical Device - Licencing Process of a CE Marked Device Canada Medical Device Regulations 2
Q Is there a formal process for disputing a 483 for a medical device company? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
W Process Validation Training - Custom made Medical Device Design and Development of Products and Processes 4
T CFDA Simplifies Medical Device Re-Registration Process China Medical Device Regulations 1
M Informational Medical Device Registration Process in Brazil - Anvisa (Part 3) Other Medical Device Regulations World-Wide 133
Q Medical Device Manufacturing Process Monitoring Best Practice ISO 13485:2016 - Medical Device Quality Management Systems 2
R Regulation Process for Add on Accessory to an Existing Medical Device Other US Medical Device Regulations 1
V Overview of the Medical Device Approval Process in Major Markets Worldwide Other Medical Device Related Standards 2
S Cadastre Process and Brazil Medical Device Registration Differences Other Medical Device Regulations World-Wide 7
J Is the SFDA in China in the process of updating their Medical Device Regulations ISO 13485:2016 - Medical Device Quality Management Systems 3
M Medical Device Registration Process in Brazil - Anvisa (Part 2) Other Medical Device Regulations World-Wide 71
N Internal Audit Process for small Medical Device company Internal Auditing 9
A Flowchart to explain the Medical Device Vigilance Reporting Process wanted EU Medical Device Regulations 4
R Medical Device Certification Process of Argentina and Russia Other Medical Device Regulations World-Wide 2
C Medical Device Registration Process in Iraq Other Medical Device Regulations World-Wide 2
C Medical Device Registration Process in Taiwan Other Medical Device Regulations World-Wide 6
C Medical Device Registration Process in Iran Other Medical Device Regulations World-Wide 12
C Medical Device Registration Process in Oman Other Medical Device Regulations World-Wide 8
Q SCAR Process SCAR that works for Class III Medical Device Supplier Management Supplier Quality Assurance and other Supplier Issues 4
K Re-validation of Out Sourced Medical Device Sterilization Process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Seeking Medical Device Registration Process in Korea Other Medical Device Regulations World-Wide 4
I Medical Device Registration Process in Italy - Class I and Class II Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 2
S 21 CFR 820.75 Process Validation for Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P Essential List of SOPS for a Medical Device Development & Submission Process? ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Medical Device Field Service Performance Inspection Process Validation Qualification and Validation (including 21 CFR Part 11) 1
sagai Process Model for IEC 62304 - Medical Device Software Life Cycle IEC 62304 - Medical Device Software Life Cycle Processes 4
R Class III Medical Device with CE Mark - UK Registration Process EU Medical Device Regulations 6
I Taiwan Medical Device Product Approval Process using a Subcontractor Other Medical Device Related Standards 10
V Medical Device Regulatory Approval Process Charts ISO 13485:2016 - Medical Device Quality Management Systems 0
M Process Validation/Equipment Qualification - Class 1A (Sterile) Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 12
M Who regulates Medical Device? Global Medical Device Reporting Process Other Medical Device and Orthopedic Related Topics 6
Q CAPA - Process - Class III Medical Device Manufacturing Nonconformance and Corrective Action 7
S Medical Device Registration Process in Russia Other Medical Device Related Standards 12
C The process for Canadian Marketing of Class II, III, and IV Medical Device Canada Medical Device Regulations 4
M PQ and PPQ - Process Qualification for medical device manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 1
P Australia - The process to declare conformity for a class IIa medical device? Other Medical Device Regulations World-Wide 5
M Medical Device Registration Process in Brazil - Anvisa (Part 1) Other Medical Device Regulations World-Wide 301
V SPC (Statistical Process Control) for Medical Device Company Statistical Analysis Tools, Techniques and SPC 4
Q Design Control and Process Validation Tools and Presentations (Medical Device) wanted Design and Development of Products and Processes 7
Paul Simpson Measures of Medical Device Design Process Design and Development of Products and Processes 9
E Process Audit Timetables and Check Lists - Medical Device Industry (ISO 13485) Process Audits and Layered Process Audits 7

Similar threads

Top Bottom