Implementing a Part 11 approved fully electronic QMS system

jradford

Involved In Discussions
#21
Re: Implementing a fully electronical QMS-system. Input needed/wanted

We are using a program called Master Control for document control, and use a database system for customer complaints and CAPA
 
Elsmar Forum Sponsor

GStough

Staff member
Super Moderator
#22
Re: Implementing a fully electronical QMS-system. Input needed/wanted

We are using a program called Master Control for document control, and use a database system for customer complaints and CAPA
Hi jradford and welcome to the Cove! :bigwave:

Just curious: are you affiliated with this company (master control) in any way? If so, would you please be so kind as to state your affiliation?

If not, perhaps you can give examples of why this is/is not a good option for electronic QMS maintenance. For example, what features do you find helpful, are there any negative sides to this program?


We just want to make sure things are clear and as helpful as possible. :yes::agree1:
 

jradford

Involved In Discussions
#23
Re: Implementing a fully electronical QMS-system. Input needed/wanted

No, I am not associated with Master Control. I work for a Medical Equipment company here in upstate NY called Lucid Inc. (We manufacture a confocal microscope used for the imaging of the skin at a cellular level in real time. The advantage to confocal is it can also penetrate the skin down to 200um-300um. Think of it as a digital biopsy. No cutting involved)

Anyway, we need a document system which would follow the FDA requirements for signature approvals. During an FDA audit in 2002, the auditor did not like the email authorization we had been using. We looked around and found Master Control (at the time, it was the least costly system we could find at around $30K). It is much more than a document vault, but that is all we are using it for right now. It controls who can view and check out documents, revision control, access to draft or archived revisions, retention, review, so on...

It also has additional modules for CAPA, training, Forms, Reports, etc.
 
Last edited:
Q

quality1

#24
Re: Implementing a fully electronical QMS-system. Input needed/wanted

We used MS Access DB for CAPA and Training, All our procedures/WI/Manuals/audit reports are converted to html which are then linked/posted on our intranet. DB above are also link to our intranet. This is inexpensive and can be easily done with what you have in MS Office instead of buying another program that does the same. :D
 
Last edited by a moderator:
R

red08

#25
Re: Implementing a fully electronical QMS-system. Input needed/wanted

We currently host our own intranet, where I've converted all documents to html and have them posted, although we use it only for viewing and storage. No DB associated :( . We are actually on two missions simultaneously, 1) implement the Plexus Online system and 2) Modify the quality system and obtain AS9100 certification. I'm 90% through modifying the Procedures and WI's. So, considering I have the Plexus system, I was looking forward to not going through the converting and hyperlinking activities, and was seeking advice. I don't think upper managment will accept another software implementation.
Thanks for everyones responses.
 
I

isotexas

#26
Re: Implementing a fully electronical QMS-system. Input needed/wanted

I am currently working for a Medical Device Manufacturer and they have selected DocuWare. They are going through the "Validation Process" now so I can't say how it is going to turn out, but they considered many others and this one was their choice.
 
A

arios

#27
Re: Implementing a fully electronical QMS-system. Input needed/wanted

I used Trackwise for Complaint records and was very happy with it.

The corporate did a great job also to validate the system and took into consideration the feedback of the potential users to determeine which fields were necessary and which ones not. The package in my opinion was flexible to allow this customization.
 
B

bubonic

#28
Re: Implementing a fully electronical QMS-system. Input needed/wanted

I'm in a medical laboratory (UK) and all our labs across the city (Glasgow) are using Q-Pulse QMS (Gael Ltd). Modules include: Document control, Audit, CA/PA, Assets, Suppliers, Training, Analysis etc. I've been a user for about 5 years and in my opinion it is fit for purpose and improves continually with the company being very good at listening to customers. It has web functionality although I haven't required to use this feature.
 
P

Polly Pure Bread

#29
Re: Implementing a fully electronical QMS-system. Input needed/wanted

Implementing a fully electronically QMS-system will have an impact on many parts of the organization. Processes, people, technology and management will undergo change. Whatever technology you may use, this needs to become a way of life within the organization. This may require changes to processes to support paperless QMS system, and people will need to be trained and understand the importance of paperless QMS system.

Once you have chosen what technology you are going to use, you will be dealing with new challenges such as resistance to change, gaining commitment, involving, communicating, etc.
 
C

Chris Ford

#30
Re: Implementing a fully electronical QMS-system. Input needed/wanted

Hi,

Hope this is the right forum :)

I am curious if any of you have tried to implement a fully electronical QMS system (doc., capa, audit etc.) that is part 11 approved. What systems have you tried to implement, and what experiences have you gained from this. Can you endorse any of the systems, and why? What has been good, what has been bad, and how did you go about it?

Let me hear from all of you :bigwave:
I implemented Agile PDM at two companies and have seen it used at several others. It's very pricy but very efficient. I have not seen an implementation for a couple of years, and I don't know what it's like now that Oracle owns it - my guess is things like implementation support and post-implementation support probably improved. I implemented the original Agile document management system, then added modules to it at one company. Then implemented PDM at another company. Both cases were Class III manufacturers. Both validation protocols included validation of signatures and electronic records. Also, both were inspected by FDA, and in both cases the investigator complimented our implementation and validation. Big gold star...

And now for my disclaimer - I'm not affiliated with Agile or Oracle... blah blah blah.

Of course, not to say there aren't dozens of other packages out there. I've seen many from home-grown to store bought to customized configurations. I just like Agile. :yes:
 
Thread starter Similar threads Forum Replies Date
J Implementing Machine Replacement Part Reverse engineering technology Manufacturing and Related Processes 3
T One Man Medical Devices Company implementing 21 CFR Part 820 in order to sell to US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Currently implementing Part 145 repair work - CMM (Component Maintenance Manual) Federal Aviation Administration (FAA) Standards and Requirements 5
gard2372 Implementing Lean Flow in Customized Aviation Part 145 Repair Station Federal Aviation Administration (FAA) Standards and Requirements 3
H Implementing ISO22301 on a Limited Scope Business Continuity & Resiliency Planning (BCRP) 1
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
L Implementing the PRRC role in a company EU Medical Device Regulations 7
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
B Lessons Learned Implementing ISO 50001 (Chemical Engineering Progress) Other ISO and International Standards and European Regulations 0
C How medical device manufacturers are implementing standards like GDPR and HIPAA Other ISO and International Standards and European Regulations 5
M Informational EU – Commission Implementing Decision (EU) as regards the designation of expert panels in the field of medical devices Medical Device and FDA Regulations and Standards News 0
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
tnorton Lessons learned from implementing Customer Complaints Customer Complaints 1
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
S Implementing a 45001 Health & Safety standard - Internal audit plan wanted Internal Auditing 1
M Informational Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Medical Device and FDA Regulations and Standards News 0
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
I First Time Implementing Document Control for ISO-9001 - how far back do you go? Document Control Systems, Procedures, Forms and Templates 15
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
J Implementing EN 62304:2006 on existing and proven medical devices IEC 62304 - Medical Device Software Life Cycle Processes 6
M Medical Device News MDR and IVDR implementing measures rolling plan EU Medical Device Regulations 0
B Implementing an Escalation Process and Andon system Supplier Quality Assurance and other Supplier Issues 1
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
T Is there any requirement to be compliant with IEC 62304 while implementing ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
A Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and... ISO 14001:2015 Specific Discussions 1
G Heavy Civil Construction Company Implementing ISO 9001:2015 for Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Implementing ISO13485:2016 in the Middle of a New Device Project ISO 13485:2016 - Medical Device Quality Management Systems 1
D Implementing 5S for Multiple Shop Floor Layout Workstations Lean in Manufacturing and Service Industries 2
N FDA Guidelines for implementing Continuous Improvement Process US Food and Drug Administration (FDA) 5
Q Easy Way of "Implementing" Risk in ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N Implementing ISO 17025 in a Calibration Laboratory ISO 17025 related Discussions 8
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Implementing an AS9100 Aerospace Quality System AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
L Implementing ISO 9001 in small Trading Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Implementing a set of bore gages at a machine Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A Implementing Risk Management in a Medical Device "Distributor Only" company ISO 13485:2016 - Medical Device Quality Management Systems 2
T Implementing a Suspect Counterfeit Identification Program Quality Manager and Management Related Issues 3
O Implementing Lean Intranet Sharepoint Lean in Manufacturing and Service Industries 6
F Implementing ISO 9001:2008 in a new Food Processing company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 22301 - Implementing a Business Continuity Management System Business Continuity & Resiliency Planning (BCRP) 15
M Does anyone here have experience implementing PCI DSS (Data Security Standard) IEC 27001 - Information Security Management Systems (ISMS) 10
L Implementing a new quality management system for a new engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Implementing ISO 9001 in an Assembly Plant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Understanding and implementing ISO 17025 ISO 17025 related Discussions 9
Q Implementing ISO 9001 and ISO 22000 systems at the same time Document Control Systems, Procedures, Forms and Templates 2
E Implementing a Production Accountability Program Manufacturing and Related Processes 3
J Implementing a TrackWise eQMS System Quality Assurance and Compliance Software Tools and Solutions 3
S Help for Implementing a Quality Management System Quality Management System (QMS) Manuals 3

Similar threads

Top Bottom