SBS - The best value in QMS software

Would an MRP system that has been in use for over 10 years require validation?

Elsmar Forum Sponsor

William55401

Quite Involved in Discussions
#2
If it is used for purchasing controls and for managing bills of material, I say yes it would require validation. I am not aware of any date related exemptions for QS related s/w.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Would an MRP system that has been in use for over 10 years require validation?
I would think that you would have enough history to readily document its performance, etc.

Not directly related, but I remember a Motorola audit where the auditor started a write-up over a calibration issue of some kind of an instrument at some point in an old, well established process. We brought out something like 10 years of data showing that there hadn't been any problems (such as failures or customer returns or complaints). I think there was also a question regarding operators not using ground straps and none were provided. The auditor's concern was ESD related. When you have a lot of historical data there are some things that are proven.

:2cents:
 

yodon

Staff member
Super Moderator
#4
While the previos responses are good, do realize that validation is a continuous operation. Changes (more users, different use scenarios, additional capabilities, supplier updates, database engine updates, etc.) all need to be assessed for impact to validation. So yes, required; maybe suitable historical info to assert it's currently in a validated state; but that shouldn't be the end.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
While the previos responses are good, do realize that validation is a continuous operation. Changes (more users, different use scenarios, additional capabilities, supplier updates, database engine updates, etc.) all need to be assessed for impact to validation. So yes, required; maybe suitable historical info to assert it's currently in a validated state; but that shouldn't be the end.
I think that is always the case. Any change to a process requires a new validation, or an abbreviated validation of the aspect(s) changed. Do you agree?

I think of APQP - Most people think of APQP as ending as production starts, when in fact, APQP continues until a part is totally out of production.
 

mihzago

Trusted Information Resource
#7
Validation is required. What may not be required is testing. Many people are confusing validation with testing and are often overdoing it.
Validation comprises variety of activities (e.g. define requirements, assess risks, vendor assessment including review of their documentation if available), which is continuous as others stated; testing is only one part of it.

As part of your validation, you'll have to answer the tricky question of why you didn't perform it prior to the use and how do you know that the software worked OK for the last 10 years.
 
Thread starter Similar threads Forum Replies Date
R ERP/MRP system as part of the QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
T Visual Manufacturing MRP system software - Who else uses their MRP software? Quality Assurance and Compliance Software Tools and Solutions 2
S SX MRP Software MTR (Material Test Report) Module Quality Assurance and Compliance Software Tools and Solutions 4
M MRP/QMS Software Package to replace our current Paper QMS - Help Quality Assurance and Compliance Software Tools and Solutions 4
I MRP/ERP for small CM/EMS Manufacturing and Related Processes 3
Q What does MRP stand for? Manufacturing Resource(s) Planning Misc. Quality Assurance and Business Systems Related Topics 4
Q MRP Software Validation Quality Assurance and Compliance Software Tools and Solutions 4
A Running MRP and Kanban on the same blank/part - Is this possible? Lean in Manufacturing and Service Industries 3
H Calibration of Measuring instrument, MRP gauges in machining General Measurement Device and Calibration Topics 2
H Best ERP, MRP Application, considering Quality? Manufacturing and Related Processes 22
J MRP / ERP Software Systems - Small medical laser manufacturing company - ISO 13485 Quality Assurance and Compliance Software Tools and Solutions 6
John C. Abnet Terms- Different Items in a system ISO 26262 - Road vehicles – Functional safety 0
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
G Management Review (integrated system) Management Review Meetings and related Processes 17
M Unique Quality Management System for 2 sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Orthopedic Implants (Knee system) Sterilization Indicators Manufacturing and Related Processes 6
C Projects in the CAPA system Preventive Action and Continuous Improvement 6
E Insulation diagram for ECG monitoring and diagnosis system. IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
J Mastercontrol or other system ISO 13485:2016 - Medical Device Quality Management Systems 0
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
P MSA - what exactly mean "system" and master sample Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
P MSA study for visual system with artifical inteligence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
D Big companies suffer from quality management system? ISO 13485:2016 - Medical Device Quality Management Systems 1
qualprod Assign a name to a home-made ERP system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Biological indicator system classification under MDR EU Medical Device Regulations 2
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
J Audit Checklist for Integrated Management System for ISO 9001:2015, ISO 14001 & OHSAS18001 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R How would you work without a quality management system? IATF 16949 - Automotive Quality Systems Standard 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
D EQMS - When the internet or system might not be available ISO 13485:2016 - Medical Device Quality Management Systems 7
Ron Rompen MSA on automated measurement system - Multiple Step Vision System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S Quality management system (Well head installation & maintenance) Quality Management System (QMS) Manuals 5
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
P How to develop executable quality management system for rookies? IATF 16949 - Automotive Quality Systems Standard 9
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
G IMS (Integrated Management System) 9001, 14001 & 45001- Request Assistance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
R SAT (System Accuracy Test) temperature according to AMS2750E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Building up a global quality management system ISO 13485:2016 - Medical Device Quality Management Systems 2
A Building up a global quality management system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
H Pedicle screw system Conformity Assessment Other Medical Device Related Standards 2
S Rees System Validation Qualification and Validation (including 21 CFR Part 11) 1
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4

Similar threads

Top Bottom