P
PMIN92618
My company is looking to move from a paper based QS to electronic.
Does anyone have any resources/templates/guidance documents they can share?
Does anyone have any resources/templates/guidance documents they can share?
Moving from a Paper based Quality System to an Electronic Quality System
Re: Paper to Electronic QS
Not certain what kind of templates you'd be looking for, as anything would be dependent on the particular requirements of your system.
My advice is this:
1. Try to adopt (or plan for) an integrated system, so that documentation between processes is consistent. There are many software solutions available. Do a web search for "ERP Software" or "MRP Software", and see which systems might best suit your needs.
2. Give yourself plenty of time to transition. Consider a transitional hybrid (paper+electronic) system first, and focus moving the "easy" stuff (processes with the least documentation) to electronic medium first, so you can iron-out any issues early on.
2. If you deal with the US FDA, ensure that requirements of CFR Part 15 are met.
Good luck!
MM
Not certain what kind of templates you'd be looking for, as anything would be dependent on the particular requirements of your system.
My advice is this:
1. Try to adopt (or plan for) an integrated system, so that documentation between processes is consistent. There are many software solutions available. Do a web search for "ERP Software" or "MRP Software", and see which systems might best suit your needs.
2. Give yourself plenty of time to transition. Consider a transitional hybrid (paper+electronic) system first, and focus moving the "easy" stuff (processes with the least documentation) to electronic medium first, so you can iron-out any issues early on.
2. If you deal with the US FDA, ensure that requirements of CFR Part 15 are met.
Good luck!
MM
Re: Paper to Electronic QS
FWIW, the only systems I've seen electronic that didn't have top management and most managers ripping their hair out are step-by-step adoption in a home-made system.
If you are not already on ERP or MRP...that is one BIG step...both in time, frustration and cost.
Our transition has been pretty smooth...we build the software in-house ourselves and adopt one system at a time. Been 10 years, smooth...2 years would have been very painful.
FWIW, the only systems I've seen electronic that didn't have top management and most managers ripping their hair out are step-by-step adoption in a home-made system.
If you are not already on ERP or MRP...that is one BIG step...both in time, frustration and cost.
Our transition has been pretty smooth...we build the software in-house ourselves and adopt one system at a time. Been 10 years, smooth...2 years would have been very painful.
Kronos147
Trusted Information Resource
I'm a dinosaur, I know. 
I use MS Excel for our form 0001 - Master Doc List.
There is an active and an obsolete tab.
In the active tab, each row lists a form/procedure/work instruction and I have columns for Form, Rev., Rev. Date, Doc Title, Reason for Creation/Revision, Date of Review, Reviewer, and Notes.
In the Doc Title column, I link the correct document to my form 0001.
I have someone test the link as part of the document acceptance process (in case I thought I did it and just checked the box).
The Master Doc List obsolete tab is not linked.
Current revisions are on a shared network drive with appropriate network permissions (read only, full access...). Obsolete revisions are moved to a drive that is only accessible by doc control and upper management.
I also keep (*gasp*) three ring binders for the Quality Manual, the Procedures, Work Instructions, and Forms. Each doc has a hard copy in the book with the hard copy of the approval\training form. The fields on the approval\training form are the same as on the Master Document List, to make copy and paste easier.
To access documents, employees go to the Master Doc List and click or they go to the forms folder and go to form 0024 - ASL, because it is easy to get to. It is also cool to see people go to a folder and type "0-0-2-4 enter" and see their form pop up. It has impressed an auditor before.
I use MS Excel for our form 0001 - Master Doc List.
There is an active and an obsolete tab.
In the active tab, each row lists a form/procedure/work instruction and I have columns for Form, Rev., Rev. Date, Doc Title, Reason for Creation/Revision, Date of Review, Reviewer, and Notes.
In the Doc Title column, I link the correct document to my form 0001.
I have someone test the link as part of the document acceptance process (in case I thought I did it and just checked the box).
The Master Doc List obsolete tab is not linked.
Current revisions are on a shared network drive with appropriate network permissions (read only, full access...). Obsolete revisions are moved to a drive that is only accessible by doc control and upper management.
I also keep (*gasp*) three ring binders for the Quality Manual, the Procedures, Work Instructions, and Forms. Each doc has a hard copy in the book with the hard copy of the approval\training form. The fields on the approval\training form are the same as on the Master Document List, to make copy and paste easier.
To access documents, employees go to the Master Doc List and click or they go to the forms folder and go to form 0024 - ASL, because it is easy to get to. It is also cool to see people go to a folder and type "0-0-2-4 enter" and see their form pop up. It has impressed an auditor before.
Spreadsheets such as MS Excel definitely have a lot of potential.
I've considered using spreadsheet applications for many things, I just struggle with how they can be adequately controlled (as per 21 CFR 11) if accessed by multiple personnel.
I'm probably missing out on some of the spiffy new features that allow for access to be controlled, changes traced, and integrity preserved...
I've considered using spreadsheet applications for many things, I just struggle with how they can be adequately controlled (as per 21 CFR 11) if accessed by multiple personnel.
I'm probably missing out on some of the spiffy new features that allow for access to be controlled, changes traced, and integrity preserved...
P
PMIN92618
Re: Paper to Electronic QS
We are looking at using a system called Doc Control- anyone heard of it?
We are looking at using a system called Doc Control- anyone heard of it?
If your QMS is paper-based, don't your templates already exist? Or am I missing something?
Should your organization opt to go the document software approach, keep in mind that modifications from the canned templates to what your organization wants costs money...not just with this version, but on supported upgrades/transitions/migrations, as well.
DEVigil
Involved In Discussions
Do you mean resources for how to decide on (and then plan the transition to) an electronic document management system? Project management-type stuff?
We are a small company currently using a paper-based system, too. I put together a high-level list of requirements so we could research products, but ultimately the cost for a system that would meet them all was deemed too high at present.
The key really is to define your requirements up front, especially any industry-specific ones (Part 11, I'm looking at you...). Have that in place before you go shopping for the product/service.
RoxanneB & DEVigil make good points regarding cost.
If you run a relatively small shop, or have particular requirements, maybe a commercial software package is not the ideal solution.
As RoxanneB points out, if you already have paper-based forms, then these are your templates. Creating an electronic system may be a simple matter of converting these to PDF forms, and then finding some FDA 21 CFR Part 11 compliant system for storing, accessing, and signing the PDFs.
MS Word and OpenOffice both have standard features for creating PDF forms...so if you've already got the paper-based source files for your forms, you'd just have to add in the form fields to your existing form source files...
P.S. not familiar with Doc Control ...there are just so many options out there...
If you run a relatively small shop, or have particular requirements, maybe a commercial software package is not the ideal solution.
As RoxanneB points out, if you already have paper-based forms, then these are your templates. Creating an electronic system may be a simple matter of converting these to PDF forms, and then finding some FDA 21 CFR Part 11 compliant system for storing, accessing, and signing the PDFs.
MS Word and OpenOffice both have standard features for creating PDF forms...so if you've already got the paper-based source files for your forms, you'd just have to add in the form fields to your existing form source files...
P.S. not familiar with Doc Control ...there are just so many options out there...
P
PMIN92618
Hi DEVigil,
Yes that is exactly what I man- how to plan the transition. Since we are small, any change will be big and effect different areas.
Also, as someone mentions, the software upgrades from time to time will also be costly ( since we will need to perform validations each time).
Yes that is exactly what I man- how to plan the transition. Since we are small, any change will be big and effect different areas.
Also, as someone mentions, the software upgrades from time to time will also be costly ( since we will need to perform validations each time).
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