anyone going paperless? (revisited)

[oncoming storm]

Hi all,

mreyes posted a question earlier in the year about going paperless and I thought it an interesting question worth asking again.

It would be nice to be completely paper free. ARUP Laboratories in SLC has many routine tests that are currently completely paperless. However, the cost is HUGE and the engineering required to make incompatible systems work together is a marvel. (They have the budget for it.) For those of us who have smaller budgets, it isn't feasable yet.

What I have used in the past, though not all at once:

Software programs such as Master Control to keep your SOPs and training documents. (My lab is working on our own software at the moment)
Electronic record of chemicals and reagents that track manufactured, in use, and expiration dates. (Still have to print labels but do they count?)
Electronic backup and storage of data. (Empower is really good at this).
Instrumetation software that can export to excel which can then be imported into a LIMS system. (Need really good computer engineers to do this)

Of course, your clients have to have the desire and capability to receive any electronic reports and there is the problem of data security.

Any other thoughts?

[danko]

The topic is interesting indeed, because there are benefits to paperless data-handling.
But one has to implement many things simultaneously in order to accomplish a successful system.
Unfortunately, the case is often as follows:
People have acquired some routines and they do not feel like changing anything. For instance, calculating results in Excel – as you mentioned.
Another one is, using unprofessional LIMS.
A third one is having a good LIMS and everything else that is needed, but not using them to the full of their capabilities.
Finally and most importantly: People that are responsible for implementation of the necessary application/s and routines just don’t understand the needs and the potentials in detail.
There are some LIMS that can communicate seamlessly with some CDS etc. do additional result calculations (if necessary) handle ER (electronic records), ES (electronic signatures) and everything else needed for implementation of a paperless workflow.
So, if one buys the right tools and uses the right people in the implementation phase, everything can be done rationally, smoothly and at a reasonable cost.
Unfortunately this is very seldom the case and that is the reason for many bad examples/attempts.

Best Regards

[fstabile]

I think this is the way of the future.

Where I am, right now, we are trying to implement a full paperless system. The main problem comes with the software and IT support. It really hurts when a problem arises, because it seems that normal IT support doesn't quite understand what lab paperwork is really.

The fact that the computer department doesn't like that a user becomes 'admin', even if it implies only for specific parts of software (like almost all CDSes)

Well, thats my two cents. Might not be the same everywhere...

[unmgvar]

i agree with fstabile that going paperless requires a new level of cooperation with IT departments.
from what i see they really do not understand the service they need to give,
they have no idea and many times do not really want to try ;on how to correclty solve communication problems between different interfaces.
theses days they need to manage:
PC running windows with XP or Visra (first major problem; a microsoft product. and you never have one type of hardware PC in your lab no matter what)
net infrastructure-routers and such
server machines, either local or not running either on unix, windows server , linux go figure,
virtual machines
main storages such as netapp or others,
data bases made of oracle or SQL
C/S printing services,
anti-viruses
firewall
citrix or terminal servers applications,
CDS
LIMS

simply add to this GLP and 21 CFR part 11 and you get a great bowl of "stew"

one good way to manage that i have seen is first to correctly describe the relationship between the lab and the IT something close to client and "service giver" relation.
create a set of well define URS by the lab that is completely in cooperation with the IT and do involve your CDS vendor in the project. if you use LIMS have them in cooperation as well.
understand the limitations and the possibilities.
aks your vendor to show you a customer that is aready implementing such an environment.
understand that your IT will always need to debug and make special settings to the system upon installation, but google has the answer for you to your solution alway;s so use it to solve bugs.

[sergioanis]

we have 2 situations with going paperless:

1) IT doesn't really colaborate. I think that they have a misunderstanding of their rol in the company. They believe that they are the reason for the company to exists, when in fact they are support people for the company to run smoothly. That translate into: we know what you want, don't ask anything else.
2) legal department put some restrictions on how the electronic notebook should be used. They have a valid point: once in electronic format , always there. Any mistake can not be corrected and can be misinterpreted in a trial.

And I should add, some chemist don't like it and they have an electronic and printed version of everything. Changes take time.

[mreyes]

Our current lab uses:
Master Control for SOP's
Documentumfor Batch Records
NuGenesis SDMS for Print and File storage from standalone and HPLCs intrsuments.
Empower to control HPLCs
LIMS for Production, QC and Stability protocols and tests.
electronic notebook for R&D.

As i go through reading all the replies to this thread, everything is true.

Expense is huge.

With each new software, we had vendors and consultants to help us implement.

It is true that the IT department and core members from cooperating departments have to be flexible and competent enough to know how to communicate their needs to each other without getting lost. It is going on 1 full year since deployment of our electronic notebook, and it still is a learning curve.

One of the hardest obstacles that we are still trying to overcome is comunication and geting cooperation from different departments.

Since our systems are realitivly new, the benefits are great. To summarize (in my department , R&D), we have seen an increase in productivity from both auditors and scientists. Luckily we have good people that were patient enough to learn the software.

[HW Mueller]

Sometimes I get the feeling that we are here on this world to "learn the software".

[Consumer Products Guy]

Our boss wants us to print out chromatograms for everything in GLP work. We had previously reviewed the raw data on the computer, then adjusted integration factors, etc., then printed chromatograms and areas of each injection for the GLP file, so less paper was used and stored. Now, rather than do that, they want initial printouts as well, increasing paper use, so any GLP auditors won't question why there weren't more chromatograms.

At least for cGMP work we don't need to print everything out, can review on the computer, let the computer system store the raw data, and print a sequence summary report.

[danko]

Costumer Product Guy,

With regards to what’s relevant to print, or should I say traceably store, there is this FDA guide http://www.fda.gov/ora/compliance_ref/Part11/ which is - I would say - self-explainable.
The essence of it is, data integrity and reliability. I personally don’t think these rules present any kind of obstacles to a successful implementation of paperless routines. But as mentioned earlier, the people responsible for implementing such a system have to be competent and serious about it. Now I don’t know how you handle all the steps etc. But if you see too many problems, maybe you should talk to the management in order to take the necessary actions and sort these problems out.
One thing I know from personal experience: If you leave the decisions, implementation etc. to amateurs you’ll regret it for the rest of your life.

Best Regards

[bonaparte]

My current section of my laboratory (government lab) is going paperless. It has been pure hell and a good part of the reason I'm leaving.

Our production has been cut in about half, which is death anywhere except for a government lab.

Somebody mentioned above that going paperless actually increased the productivity of their company. I would be interested to hear how that worked out.

I'm not saying paperless is a bad thing, it is just the people implementing it, and the software we are forced to use which is killing us.

[Csaba]

Hi,
My experience is that it is possible to go paperless if management, project team and IT have lot of common sense. In my opinion it is rare. And if just a tiny part is missing, going paperless will cost a fortune and not improve productivity.

[Paulhurleyuk]

I think you have to ask a mor ebasic question; "what aer you trying to achieve ?".

Most groups I have met that have tried to eliminate paper are either tryign to save time/money or trying to improve compliance to the rules that apply to them. In my experience eliminating paper can help in these circumstances, but not every time.

Sometimes, paper is just the best way to record, store and trasnmit information. In my own little world, we try to have less-paper, not nessarily go paper-less. Systems I've used int he past such as Chromeleon and NuGenesis SDMS are amazing at eliminating time and effort on things you don't need to do....

Just my two cents....

Paul.