RE: QMS

Being close to what is required by some companies on the Quality Management
side, I would like to comment on some criteria that might justify replacing
QMS/LMS by something else.

Most of the time, BPCS users mention the functional and user-friendliness
limitations of QMS but also refer to regulatory requirements that are
lacking in this module (at least in the version I know).

For FDA regulated companies, QMS is assimilated to a LIMS (Laboratory
Information Management System) ; since it holds records required by the FDA,
the system has to comply with the regulation (GMP's, 21 CFR PART 11...).

To name a few of these requirements :

System security shall be managed in a way that only the system responsible
person can manage system access and grant authority to users ; if this is
not the case, the system is considered as "open" and the system must provide
additional security measures (data encryption...)
The maintenance of the master records (specification, methods...) included
in QMS has to comply with GMP requirement i.e. version control, change
control, approval...
It is required to track any changes performed on master & batch records
through an independant and automatic audit trail system.
Paper & Electronic copy of the records shall be made available to the FDA
for inspection.
Depending on predicate rules defined by the GMP's, the system shall record
the reason for change upon a specific event (as an example, changing a test
result requires a reason for change).

On the electronic signature :

Each action that requires a signature in a paper-based world shall be
replaced by an electronic signature compliant with 21 CFR PART 11.
Full Name of signer (not user ID) shall appear on all screens and paper
outputs of the system.
Signature record shall be date/time stamped with the local date/time of when
the signature was done (for systems that span across multiple time zones),
The signature shall include the meaning of the signature i.e. approved by...
Access to the system is considered as an electronic signature
Each signature attempt (successfull, non successfull) shall be logged.
For signature based on user ID/password combination, additional measures are
required (rules for managing passwords...)


These are some of the requirements that all FDA-regulated companies must
follow.

In addition to functional limitations that QMS/LMS may have compared to
other systems, these requirements are non-negociable with the regulatory
agency ; hence they justify looking for another compliant product interfaced
with BPCS.

Jean-Louis JOUVE


-----Message d'origine-----
De : bpcs-l-admin@midrange.com [mailto:bpcs-l-admin@midrange.com]De la
part de DAsmussen@aol.com
Envoye : mardi 27 novembre 2001 06:24
A : bpcs-l@midrange.com
Objet : Re: QMS


Marc,

In a message dated 11/26/01 8:05:47 AM US Eastern Standard Time,
jyoung@haynesintl.com writes:

<<snip>>
> >         Has anyone ever used another software to replace the QMS module.
<<snip>>

In my experience, there are only four types of companies looking to ditch
QMS.  In order of frequency, they are:

1.  The company that did not sufficiently train on QMS.
2.  The company that hired a consultancy that did not sufficiently train on
QMS.
3.  The company that doesn't maintain sufficient staff to modify QMS to meet
their needs.
4.  The company that cannot use QMS.

I know of no (viable) replacement for QMS.  I know of several companies that
have written their own version, but those are not commercially available.
What are you trying to do that QMS does not?

Regards!

Dean Asmussen
Enterprise Systems Consulting, Inc.
Fuquay-Varina, NC  USA
E-mail:  DAsmussen@aol.com

"There are no shortcuts to anywhere worth going." -- Beverly Sills
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