Validating for 21 CFR Part 11 and Calibration Management Software

							Title:
Validating for 21 CFR Part 11 and C
alibration Management Software

Word Count:
997

Summary:
Validating Calibration Management S
oftware for 21 CFR Part 11 is a pai
n, but with the right mind set the
process can be speedy and beneficia
l. Given some trade tips and good a
dvice there is an easier way to pla
n, construct and execute a validate
d compliant management software for
 the pharmaceutical and medical wor
ld of metrology.


Keywords:
calibration software,calibration ma
nagment software,lab management sof
tware, equipment management softwar
e, calibration, software,21 cfr par
t 11


Article Body:
The whole process of purchasing a s
oftware package, figuring out the a
uditing logs, purchasing a validati
on protocol purchasing training on
the protocol, hiring help and filli
ng out the 500 – 1,000 page documen
t for 21 CFR Part 11 compliance is
as tedious as it is mind-numbing. O
n the fun things to do list working
 on validating software for 21 CFR
Part 11 falls somewhere between get
ting a root canal and walking on br
oken glass. All that said, as with
any other torturous activity, valid
ating software can be made easier a
nd relief can be found given some tips.

<b>Choose the Right Calibration Man
agement Software</b>
If the software being validated has
 already been purchased then ignore
 these next paragraphs and move on,
 otherwise read on.
The task of finding the best fit so
ftware for any given company is a w
hole dissertation in itself. see th
e article entitled <a href=http://w
ww.amazines.com/Computers/article_d
etail.cfm?articleid=69350&Title=Cho
osing%20Calibration%20Management%20
Software>Software, Software, Everyw
here Software</a>, published in Cal
lab Magazine, by Brad Price, Presid
ent, One Red X Software, Inc. for a
 detailed process for finding the b
est software. The importance of fin
ding acceptable, robust and stable
calibration management software can
not be stressed enough. Too often c
ompanies rush into a software choic
e that will most likely be replaced
 in a couple years because of new t
echnology or bad design.
Briefly, here are the main points f
rom “Software, Software, Everywhere
 Software” for choosing calibration
 management software:
Evaluate the environment that the s
oftware will be run on and make sur
e that you have the hardware availa
ble for the software.
Before seeking a software package s
it down and develop a simple work p
rocess flow chart of your facility,
 starting from the time you contact
 the customer through the time you
return the equipment to the custome
r.
The next step is to determine what
operating system and style platform
 you want to run on.
Lastly, ask the right questions. Fi
nd out everything you can about the
 software company, references and w
hat features the software offers. I
s the software flexible for the lon
g run and will technical support be
 available when needed? Ask the que
stions and record them to decide wh
ich software vendor is going to sat
isfy the needs of the company best.

<b>Understand the Software</b>
Before beginning the validation, it
 is prudent to actually know the so
ftware, so you will be able to spea
k intelligently with the vendor and
 coworkers optimizing the validatio
n procedure. The 21 CFR Part 11 com
pliant software</a> should have an
auditing log and electronic signatu
re function that would be important
 to find and understand well. Some
basic understanding of the software
 will help immensely especially sin
ce the software has to be validated
 by the customer themselves. When t
he validation protocol is being exe
cuted, this basic understanding com
es in handy as the user moves throu
gh the software validating function
ality. The point is: time will be s
aved no matter how you look at, if
you simply experiment with the soft
ware or have some basic knowledge o
f how the software works before goi
ng through the validating long haul.

<b>Setting up the Environment</b>
Before starting the validation proc
ess verify that the business practi
ces for the software are in place a
nd all the customizations have been
 completed for the software. Softwa
re packages usually have a lot of s
ettings, customizations, workflow p
rocesses and reports that are set-u
p specific to a companies requireme
nts. Make sure everything is custom
ized correctly and ready for use be
fore validating the software, this
decreases the chance of returning t
o patch up things that change later
. Talk with the vendor, validation
experts and anybody else that may h
ave experience preparing for a vali
dation for that software.

<b>Schedule the Completion</b>
Create a deadline for the validatio
n to be completed. Ask the software
 company how long approximately it
takes to complete the validation do
cument and schedule accordingly. Fi
nd out if the document can be compl
eted by more than one person and if
 so the work of executing scripts m
ay be split up between two or three
 persons. Have a validation expert
review the document often to verify
 that the proper steps are being ta
ken to make sure the document is be
ing completed right the first time.

<b>Begin using the Document</b>
Start at the beginning of the docum
ent. This may seem obvious, but it
is important to complete whatever p
rerequisites that the document spec
ifies first before continuing in th
e document. The prerequisites often
  require that the system requiremen
ts are met and the environment is s
et-up correctly.
The document should be straight for
ward and easy to use. So if somethi
ng seems not quite right, something
  probably needs to be adjusted and
calling the software vendor or vali
dation expert is suggested.
Here are some general rules as one
goes through the validation process
:
Consider the option of testing the
software on a copy of the software’
s database, thus eliminating the ch
ance of damaging real data or addin
g a slew of play data from the test
ing.
If something seems hard or confusin
g, stop and call the vendor or have
 a validation expert review the doc
ument.
For customized systems, the scripts
 in the document may not read exact
ly the same as it is in the softwar
e itself. Amendments may need to be
 made to the document to match thes
e software customizations. So, if s
omething can’t be found or is drast
ically different in the document ve
rify you have the right document ve
rsion for the software and that the
 software hasn’t been customized di
fferently from the COTS (commercial
 off the shelf) system.
If the software has a backup option
, backup often! Who knows what kind
 of mess will be caused as the soft
ware is tested for all sorts of ang
les, that way you always have a sto
pping point to return to.

<b>In Conclusion</b>
The validation process is not fun b
ut maintaining consistency in compl
eting it and staying in contact wit
h the software vendor and validatio
n experts will ensure a speedy vali
dation. Good Luck!