SBS - The best value in QMS software

How to document Software used as Monitoring and Measuring Devices (7.6)

rvanelli

Involved In Discussions
#1
I hope I'm in the correct forum but my question is how to document software when used as a monitoring and measuring device as it pertains to section 7.6 in the ISO standards. I know it should be verified and reverified at selected intervals but what is the best way to document this verification and reverification?

Thanks, Rick
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
1) Validation Plan
2) V&V protocols
3) execute the protocols
4) write the report(s)

As part of the validation plan, you'll define controls to periodically review the need for re-validation (based on code changes, environmental changes, etc.) and at that time, you would just iterate through the loop again.

Being in a validated state requires that the controls are in place to manage the changes (i.e., a well-defined software development life cycle [SDLC]) so it's by no means a "test once and done" situation.
 
Thread starter Similar threads Forum Replies Date
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C QMS Document Management Software Recommendations Quality Assurance and Compliance Software Tools and Solutions 14
J Document Control Software Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I Document Signature Software? (Certificate Authorities) Document Control Systems, Procedures, Forms and Templates 15
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
D Software for advancing with Document Control Quality Assurance and Compliance Software Tools and Solutions 4
L How document an additional software of my main device software?? IEC 62304 - Medical Device Software Life Cycle Processes 3
R Document Management Software : Validation and other requirements Medical Information Technology, Medical Software and Health Informatics 8
L Medical Device Software Document released version (article 5.8.4) IEC 62304 - Medical Device Software Life Cycle Processes 7
J How to document discontinuation or end of life for a software version ? IEC 62304 - Medical Device Software Life Cycle Processes 3
L OpenDocMan Document Control Software Question Document Control Systems, Procedures, Forms and Templates 2
R A simple electronic (software) document control question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Help with ECR/DCR Document Change Control Software Validation Qualification and Validation (including 21 CFR Part 11) 6
M How to Choose the Best Document Control Software Quality Assurance and Compliance Software Tools and Solutions 14
N Using ISO document number, version number in Software based solution. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Process Mapping Electronic Document Control Software Recommendations Quality Tools, Improvement and Analysis 5
B Work Instruction Application (Software for Document Control) Quality Assurance and Compliance Software Tools and Solutions 2
P Software Changes - Is an FDA guidance type of document available from SFDA (China)? China Medical Device Regulations 2
V Electronic Document Control Software suggestions wanted Document Control Systems, Procedures, Forms and Templates 14
L Data Management and Web based Document Control Software Document Control Systems, Procedures, Forms and Templates 18
S PMA Submission Software Hazard Analysis Document vs. Product Hazard Analysis doc ISO 14971 - Medical Device Risk Management 5
A Choosing Document Control Software Document Control Systems, Procedures, Forms and Templates 13
D How to Control Software Program based Forms - Document Control Document Control Systems, Procedures, Forms and Templates 1
A ISO 13485, Document Control and Software Validation ISO 13485:2016 - Medical Device Quality Management Systems 9
C Document Control Software Pricing Document Control Systems, Procedures, Forms and Templates 1
S Special 510k for Data Management Software Document Requirements IEC 62304 - Medical Device Software Life Cycle Processes 1
T Document Control of ERP Report Format from Software Document Control Systems, Procedures, Forms and Templates 13
M Document Control Software Program with Revision Tracking Recommendations Document Control Systems, Procedures, Forms and Templates 7
Casana Control ES vs. Compliant Pro Document Control Software - Recommendations please Document Control Systems, Procedures, Forms and Templates 1
B Part 11 Compliant Document Control Software recommendations Quality Assurance and Compliance Software Tools and Solutions 30
S DMS (Document Management Software) vs. Paper Copies - Cataloging all of our docs. Document Control Systems, Procedures, Forms and Templates 8
B Document Control Software Recommendations Quality Assurance and Compliance Software Tools and Solutions 7
N MasterControl Document Control Software Screen Shots wanted Quality Assurance and Compliance Software Tools and Solutions 1
F Looking for Electronic Document Control Software Quality Assurance and Compliance Software Tools and Solutions 14
M Microsoft Sharepoint as Document Control Software - FDA Validation Requirements Document Control Systems, Procedures, Forms and Templates 15
J Document Control Software - Sharepoint Document Control Systems, Procedures, Forms and Templates 14
S Validation of VCS software for document control? Small medical start-up Document Control Systems, Procedures, Forms and Templates 10
J Control of Obsolete Documents - Changing document control software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Software for ISO Document Control - Recommendations Wanted Quality Assurance and Compliance Software Tools and Solutions 7
R Document Control and Agile Product Lifecycle Management software Document Control Systems, Procedures, Forms and Templates 4
P Document Control Software recommendations for Part 11 medical device Document Control Systems, Procedures, Forms and Templates 2
A CDRH Guidance Document - Software bugs submitted in 510(k): Quantity or Quality? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
H Is software code a document or record or neither of the two? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
E Work Instruction vs. Reference Only document - Computer software use instructions Document Control Systems, Procedures, Forms and Templates 33
C Information or Recommendations for Document Control Software? Document Control Systems, Procedures, Forms and Templates 5
W Part-11 Compliant Document Control & Integrated Training Software Document Control Systems, Procedures, Forms and Templates 15
T Document Management Software for Personal Use Coffee Break and Water Cooler Discussions 4
K Software suggestions for Document Management, Audits, and CAPAs? Quality Assurance and Compliance Software Tools and Solutions 10

Similar threads

Top Bottom