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Electronic Logbook Software - 21 CFR part 211 environment (CFR 211.182)

D

DiceNa

#1
We are currently using paper logbooks in our 21 CFR part 211 environment. The logs specifically deal with equipment usage, cleaning and maintenance as called out by CFR 211.182. The paper books we currently use have some serious limitations.

I have been searching the internet for weeks and I have been unable to locate anything. I have thought about using a CMMS program, but I think that is overkill.

Is anyone aware of Logbook Software for the Pharma industry to capture equipment events?

Thanks in advance.
 

Marc

Captain Nice
Staff member
Admin
#2
A quick "Bump". I know this thread is kind of old, but any help will be appreciated! My Thanks in advance!
 

WalkingSeed

Involved In Discussions
#3
I suggest doing a search for electronic laboratory notebooks and talking to the vendors that provide this software such as Accelrys. They may have solutions available that will fit your needs. Remember that when you make the jump from paper to pc the cost of validation can easily exceed the cost of hardware and software.
 
S

schandank

#4
We exactly have same requirement. I am also actively looking for a e-logbook solution to replace paper logbook for equipment we have in GxP environment. Some option we have found so far and had demo from vendor are :
> Metrology by accelrys
> eLogger By Synapp north

we are still looking for other options. If someone know about others, please reply.

@DiceNa,
Did you already found something?

kr
Chandan Kumar
 
D

DiceNa

#5
Chadan,

I have not been able to identify anything that will meet our needs. I had a suggestion to try and adapt CMS software Maximo, but I didn't think that would work for us.
 
S

schandank

#6
@DiceNa,
So far based on our comparison of commercial off the shelf solution, Metrology stand out. I suggest to have a look at Metrology.
We now have a choice to make between Metrology and an internal SAP configured solution.
 
#7
We have a fully functional Digital E Logbook covering every aspect/ area of Pharma Manufacturing with integeration with any ERP / SAP/ Oracle system for complete process control .
 
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