21 CFR part 11 compliant Electronic Document Management Systems

A

abchris

#1
I work for a small biotech company (approx 40 employees) and we currently use an entirely paper based system for all of our documentation. We would like to migrate to an electronic document management system that is 21 CFR part 11 compliant AND not spend a fortune (target of less than 50k). This would ideally also include an easy way to link training records to SOPs too.

Does anyone have any first hand experience in assessing and implementing such a system? What are the important things to look for and questions to ask?
 
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Q

QA_chick

#2
Re: Electronic Document Management Systems

I am not familiar with the standard(s) you cited, but our company is certified to ISO 9001:2000 with HACCP based food safety management system.

We are using a web based version of CompliantPro (vendor: IBS-US) which is designed to manage a variety of documentation electronically (i.e. SOPs, CA/PA, internal assessments, calibration and maintenance, etc. etc.) including the training record linkage to SOPs that you specifically mentioned.

I was not involved in the product sourcing process, so I cannot comment on what other documentation management products are commercially available.

There is a significant learning curve in the configuration (front end work) but once configured, the program is very easy to use and effective. However, if implementing change at your company is already 'challenging' (as it is here), a business tool such as CompliantPro won't help with that...:nope:
 
T

tsmith7858

#3
Re: Electronic Document Management Systems

Do a search of the cove (or google) for document software or QMS Software and you will find a lot of threads on the topic.

I searched last year for a company I was working for and found that most packages run 10K to 30K depending on licensing and how many seats you need. (There are also annual service fees for most)

A few that I look at included Q-Pulse, MetricStream, Harrington, Interax, CEBOS, Qudos and ISO SytemPlus.

I was not looking for 21 CFR part 11 but I know many had it.
 
T

timference

#4
Re: Electronic Document Management Systems

There is a company called desert sky software. Look them up. They have a very good doument system that is web based. you can host or they will for you. If you have a goood network and a reliable back up system, hosting yourself is a lot cheaper

Out of the box is pretty good. We had to have some customization added but still spent less the 20K for 10 concurrent users. It also has a workflow for document changes, routing, approvals, distribution, etc. it even has a way to send via email and send to parties without giving them acces to the web system. It is a very good system and is compliant with any standards you need to address
 

Helmut Jilling

Auditor / Consultant
#5
Re: Electronic Document Management Systems

I work for a small biotech company (approx 40 employees) and we currently use an entirely paper based system for all of our documentation. We would like to migrate to an electronic document management system that is 21 CFR part 11 compliant AND not spend a fortune (target of less than 50k). This would ideally also include an easy way to link training records to SOPs too.

Does anyone have any first hand experience in assessing and implementing such a system? What are the important things to look for and questions to ask?
I would recommend an inexpensive step first. Put all your controlled documents in a folder and write protect the folder, so it is read-only for all the users except your document manager. Or, scan them into PDF files. Try this before you invest $$$ in a rigid database.many companies find this is sufficient.
 
S

somerqc

#6
Re: Electronic Document Management Systems

The only thing I would add to Helmut's comments is that it may be worth the investment of software if there is a high need of approvals required and there are large geographic regions separating the various approval authorities.

Otherwise, like Helmut, I KISS when it comes to document control. Oh ya, one other tip - make sure everyone knows to 'click' the read-only button :frust:
 
R

RickRay

#8
Re: Electronic Document Management Systems

We use Agile in our facility, it works fine as a PLM. It could easily be used for what you are looking for. :2cents:
 

BradM

Staff member
Admin
#9
Re: Electronic Document Management Systems

I have seen GMPharma used. It's not my favorite, and I am unsure of the cost. But I do know it is ER/E-sig compliant.

Now... that we've covered that I have used all the fancy, expensive programs, allow me to make a suggestion: Heavily consider Helmut's advice.

Being in calibration, we had about 50 technical procedures. We intentionally left it out of the "document management system" for several reasons. Primarily, you really, really get locked down in them.

Here's what we did. We had a system coordinator, and all the procedures were in Word. She would put them on the network drive, but they were read only. So, I need to make a revision. She would send a draft. If we really needed to (and there were a few times), we could implement a new revision in 20 minutes or less.

I would do a change form, have two people sign it. She would sign it once it was updated, and we're done. You could make it more simple, by having a logbook for signatures, and archiving that once a year. You would not even need change forms.

I guess I am trying to persuade you to stay simple. When you get one of those systems, you have to validate it, set up control levels and systems, be subject to obsolete versions, need for backup, archiving, etc. etc. For your size organization, it could weigh it down quite heavily.

:tg:Take that money and invest in a good calibration program!! Ha! That's my pet project, if you did not know!!:lol:
 
Q

quality.shesha

#10
Re: Electronic Document Management Systems

In our company we are paper based for all documentation purpose. Apart from this EDMS (Electronic Document Management System) is there a way out?
In our org many of them hate using papers, which is for good, and they want to have these approvals thru emails.
So, does ISO, AS & CMMi allows us to do so (Approval thru emails)?
Our's is a Engineering Services company.
 
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