Paper Based Manufacturing with an Unvalidated ERP

G

Gumby24

#1
Hi,

A friend works for an organization and he asked for my opinion in an area that I'm not fully up on. They currently manufacture non-medical products but they're at the point now of seriously considering the idea to start manufacturing a medical device.

I asked a few questions and their ERP system runs the entire business from sales order, procurement, materials management, kitting to product control and release. Validating that system would seriously constrain their main business and he wanted to know if there was a way to use their ERP system and supplemented with a paper system?

The device will use a paper based DHR and the final product will be declared into an ERP once it is complete.

The question I have relates to running the rest of the business from an unvalidated computer system. Is this possible and acceptable in the eyes of the regulators? They were told by an 'expert' they can use the ERP system to manage all of the above activities but view it as an editor where they use the system, print out the paper then simply sign and date the paper to make it a valid record.

This approach seems odd to me and I'm interested for comments if they would pass regulatory inspections with an unvalidated computer system which is used in this manner?

I'd appreciate independent input if this is proper or not? I have my own assessement but thought I'd ask in the event that I may have missed something.

Thanks in advance for any input.
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
The question I have relates to running the rest of the business from an unvalidated computer system. Is this possible and acceptable in the eyes of the regulators?
Yes.

They were told by an 'expert' they can use the ERP system to manage all of the above activities but view it as an editor where they use the system, print out the paper then simply sign and date the paper to make it a valid record.
Correct.

Very generally, manufacturing computer software that determines critical quality must be validated. So must be data analysis software that affects critical design or research determinations. Business operations software need not be.
 
Thread starter Similar threads Forum Replies Date
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
B Do you use paper or web-based templates for CAPA processes? ISO 13485:2016 - Medical Device Quality Management Systems 3
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
S Paper-based QMS ISO 13485:2016 - Medical Device Quality Management Systems 9
P Moving from a Paper based Quality System to an Electronic Quality System Manufacturing and Related Processes 14
S Migrating from paper based to electronic system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
H Paper based DHF (Design History File) updates for Software Updates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Part 11 Hybrid System - Partial paper based record but with e-signature Qualification and Validation (including 21 CFR Part 11) 4
qualprod From paper to Electronic (records) in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R ISO 45001 Lead Auditor Exam paper Training - Internal, External, Online and Distance Learning 1
M Informational US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review Medical Device and FDA Regulations and Standards News 0
M Informational US FDA paper – Biological Responses to Metal Implants Medical Device and FDA Regulations and Standards News 0
M Informational US – MITA UPDATES SERVICING AND REMANUFACTURING WHITE PAPER Medical Device and FDA Regulations and Standards News 0
M Informational FDA discussion paper – Consideration of Benefit-Risk Approaches for Weight-Loss Devices Medical Device and FDA Regulations and Standards News 0
M Informational Paper on open access – EU postmarket surveillance plans for medical devices Medical Device and FDA Regulations and Standards News 1
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Sidney Vianna Interesting Discussion ISO 9001 audits from the perspective of registrants' customers - an interesting paper Registrars and Notified Bodies 0
U Electronic templates for making paper control charts Reliability Analysis - Predictions, Testing and Standards 2
M Informational COCIR Position Paper Harmonisation of Standards for Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational COCIR paper – Advancing Cybersecurity Of Health And Digital Technologies Medical Device and FDA Regulations and Standards News 0
M Informational DITTA White Paper on Cybersecurity: Best Practices in the Medical Technology Manufacturing Environment Medical Device and FDA Regulations and Standards News 0
qualprod What tier number fits in a company producing paper labels stuck on automotive parts? IATF 16949 - Automotive Quality Systems Standard 7
C Karl Fischer Titrators and 21 CTR Part 11 and Paper Records Qualification and Validation (including 21 CFR Part 11) 6
M Medical Device News NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application” Medical Device and FDA Regulations and Standards News 0
M Position paper Team NB Statement - Patient safety EU Medical Device Regulations 0
G Calibration Certificate, fancy paper or not? General Measurement Device and Calibration Topics 9
T ISO 9001:2015 by Craig Cochran - ebook or paper? Coffee Break and Water Cooler Discussions 9
M Design of Experiments - Paper Helicopter Example Using Minitab Software 1
A Splitting Paper Routing Job Worksheets AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M How to Measure Paper considering Variation and Humidity General Measurement Device and Calibration Topics 10
L BSI White Paper on Human Factors/Usability Engineering IEC 62366 - Medical Device Usability Engineering 12
A Preventive Action or Corrective Action - Paper cuts Nonconformance and Corrective Action 14
A Receiving paper from the customer and never knowing when it will arrive Quality Manager and Management Related Issues 1
D How to approach Paper and Electronic Record Control for ISO 9001:2008 Records and Data - Quality, Legal and Other Evidence 7
S 21 CFR 11 - Require paper and hand signatures not electronic Other US Medical Device Regulations 2
Q Kraft Paper / Core Paper MSDS - Plastic Specs IATF 16949 - Automotive Quality Systems Standard 4
P EU MDD revisions white paper on the proposals for the Medical Device Regulations EU Medical Device Regulations 1
G Laser Precision Linear Measurement - Inherrent Accuracy of 10 -6 - Nice PDF Paper General Measurement Device and Calibration Topics 1
J Can Normal Probability Paper and GPC be created with Excel Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
T Paper Quality Manual Change Control Methods Quality Management System (QMS) Manuals 5
B Any suggestion on creating the best paper plane that can hit a target perfectly? Coffee Break and Water Cooler Discussions 2
N Converting Paper Records to Electronic Format Records Document Control Systems, Procedures, Forms and Templates 6
Q Sampling Plan for Paper and Tape Industry Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
M Paper Records w/ SPC - When can the paper go away? Statistical Analysis Tools, Techniques and SPC 13
Z My first Gage R&R - Paper/Poly/Foil Material Bond Test, need help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
I Electronic vs. Paper Copy Document Approval Process Document Control Systems, Procedures, Forms and Templates 9
K Records Control - How do you Manage tons of Paper Records? Records and Data - Quality, Legal and Other Evidence 10
J In which journal/magazine can I post my paper? IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
V What is the difference between Paper, Article, Review and Blog? Book, Video, Blog and Web Site Reviews and Recommendations 5
AnaMariaVR2 Paper Productivity vs. Digital Productivity Systems Quality Tools, Improvement and Analysis 4

Similar threads

Top Bottom