Paperless Document Control System - Recommendations needed

W

WisdomseekerSC

#1
We have identified a need to improved our document control system. Currently we create documents in Word (under an ECR/ECO system) and circulate via email for review using a document control coordinator. Approval is via vote buttons on the email distribution. We have a documentation pyramid with upper level documents requiring hand signatures. Superceded version are watermarked and archived. Once approved, the time window for training to new and revised documents is 30 days then the document becomes effective. The document is then posted to the Intranet for employee access (read-only).

Problem: Recent ISO system upgrades and new certifications resulted in overwhelming the document coordinator, delays in circulating and approving documents, uncoordinated changes to documents resulting in frequent rev. changes (we're going thru the alphabet rapidly), Intranet posting is jumbled, mixed levels of details and formatting in procedures, references to obsolete forms and SOP imbedded in documents, and mutany between manufacturing sites (selective applications of procedures) :braincloud:.

We also desire to train the right people to the appropriate documents and track and document the training in a more efficient manner.

Is this an impossible dream?:sleep: Of the host of software programs on the market, can anyone recommend one that also links to training records?
 
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L

LNeJame

#2
Re: Recommendations needed for Paperless document control system

Hi,

First off, disclaimer I do work for The Harrington Group, and I'm usually fairly hesitant to post when people are looking for software unless I feel that our software will legitimately fit their needs.

Very briefly, we do have a software application that will handle document control. Also there is the capability to create and link trainings based on new revisions, pretty much as you describe in your above post.

Since I am trying to keep this brief, feel free to PM me and i can provide more detailed information and also answer any questions you may have.

Regards,
Larry
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Re: Recommendations needed for Paperless document control system

I agree you may have reached the threshold where a document control software system is practical and cost effective. Please click on the links to related threads at the bottom of this page to see what others have said on this subject.
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#4
Re: Recommendations needed for Paperless document control system

I recommend MQ1 from CEBOS. I like its ease of report generation and ability to link all over the package.
 

sagai

Quite Involved in Discussions
#5
Re: Recommendations needed for Paperless document control system

We have identified a need to improved our document control system. Currently we create documents in Word (under an ECR/ECO system) and circulate via email for review using a document control coordinator. Approval is via vote buttons on the email distribution. We have a documentation pyramid with upper level documents requiring hand signatures. Superceded version are watermarked and archived. Once approved, the time window for training to new and revised documents is 30 days then the document becomes effective. The document is then posted to the Intranet for employee access (read-only).

Problem: Recent ISO system upgrades and new certifications resulted in overwhelming the document coordinator, delays in circulating and approving documents, uncoordinated changes to documents resulting in frequent rev. changes (we're going thru the alphabet rapidly), Intranet posting is jumbled, mixed levels of details and formatting in procedures, references to obsolete forms and SOP imbedded in documents, and mutany between manufacturing sites (selective applications of procedures) :braincloud:.

We also desire to train the right people to the appropriate documents and track and document the training in a more efficient manner.

Is this an impossible dream?:sleep: Of the host of software programs on the market, can anyone recommend one that also links to training records?
I would investigate first the regulatory requirements for this application.
In most cases in this medical world, used softwares are considered as SOUP and , depends on medical device classification and the market of your product, can produce enormous additional documentation (internal validation of non production software) ONLY to be able to integrate this software into the daily life of your QMS.
But yes, there is a time, when you can not go further without it.
Potential software supplier prequalification can start with the investigation of their product compliance with the notified bodies requirements.
I saw one effectively used one by one of the big three and it was not off the shelf software, because of the previously mentioned ones.

br
Sz.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Of the host of software programs on the market, can anyone recommend one that also links to training records?
IBS has some software that does. Caution: Their software is very expensive. I can't really recommend their software (setup and maintenance are not for the faint of heart), but it does have a training 'module' that integrates into their main software.
 
I

ISO 9001 Guy

#7
Another thought might be to reduce the volume of documents in the first place. It's not uncommon for companies to over-document their system and processes in an effort to become ISO certified.

How many employees are at your company? What does your company do/make? Do you have a procedure titled, for example, "Product Identification?" "Inspection and Test Status?" If you have procedures with these titles, you have an opportunity to eliminate them. Are you familiar with the process approach?
 
G

Groo3

#8
:2cents: If you wish to set up a system for your site, the best approach in my opinion would be to use the good old Kepner Tregoe "decision analysis" methodology. You should first identify what capabilities you are seeking? you can then identify 5 to 10 vendors who claim they can meet those capabilities and work through the KT process to pick the best solution for your facility or at least narrow the list down a bit. Many vendors will set up live (or online) demonstrations of their products where you can evaluate the positive and negative aspects of each and get a feel for what to expect. You should then be able to arrive at the solution that works best for your facility.

Back when we were deciding which system to purchase, we did a less formal analysis of about 30 different software programs. After narrowing that list down to a top-5, we contacted the vendors to do a hand's-on demonstration and based our decision on that...

IBS has some software that does. Caution: Their software is very expensive. I can't really recommend their software (setup and maintenance are not for the faint of heart), but it does have a training 'module' that integrates into their main software.
Please note that the system that works best for my site may not be ideal for your facility... My site uses IBS (QSI), we've been using it since about 2000. Yeah, not for the faint of heart. We use IBS (QSI) for our Document Control, Corrective Action, Management Reviews, Internal Assessments, MSDS's, Specifications, etc. We also have a non-IBS document control system (prefered by our North American headquarters) to help manage our engineering drawings and a non-IBS corporate training records database.

As for IBS (QSI), there are several software packages available, see their website for details. The package my site is using is the System 9000 A / System 14000 integrated software (about 56 databases in all, of which we really only use about 25 regularly). We get about 1 software upgrade per year with our current service plan.

As for the original subject of tracking and documenting the training in a more efficient manner, the IBS training module has improved over the years and can be set-up to be integrated into their document control system = when procedures are approved, you can enable training notices to go out to all people on the notification list (training acknowledgement can be as simple as the employee clicking on the document link, reading the document and clicking on an acknowledge training button). Employee training records can include specific documents / procedures that employees are required to review. Additional requirements can be added in the form of Site, Departmental or Job specific training requirements.

Just as I have seen lots of improvements with the IBS (QSI) software over the years, the same can probably be said of the other electronic document control / training programs that are out there? The KT decision analysis process should be able to help you determine the options you really want and decide on a solution that works best for you...
 

Pancho

wikineer
Super Moderator
#9
Hi, WisdomseekerSC!

Have you heard of wikis?

Wikis are a new medium great for documentation. They are inexpensive and easy to learn, and make document control almost automatic.

Once you upload or import your current documentation into a wiki it becomes a living asset. It is available for all to consult, it is easy to edit and maintain, version control is built in and it improves continuously.

Here are a few links that may be useful:


Good luck!
Pancho
 
I

ISO 9001 Guy

#10
If you are reviewing all options and nobody has suggested SharePoint yet, it's worth a look. Very slick document control . . . approvals, versioning, permissions, etc.
 
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