Streamlined software
Wouldn’t it be nice to be able to skip over the time, complexity and cost of validating your LIMS?
A software vendor has brought a commercial off-the-shelf software package to market that is prevalidated
and is able to provide significantly lower total cost of ownership.
For highly regulated
environments such as
the pharmaceutical
industry, purchasing a
piece of software is only
the first step in a long
process toward use in a
production environment.
Validation involves several
stages, starting with an
outline of user requirements
and a function and design
specification, through to a
review of the installation,
an operational test of
the system and finally a
performance evaluation.
The validation plan will also
include other items such as
acceptance criteria, change
control, risk management
and a plan for handling
deviations. The company
also needs to take into
account existing project and
system SOPs, the team’s
computer system training
and end-user training. Only
when all these factors have
been dealt with can the
validation execution begin.
Shortlist for success
The final responsibility for
validation compliance lies
with a drug or medical device
manufacturer, rather than
the software vendor. The
latter can provide the scripts
and documentation to
assist the customer in their
validation effort. However,
this still requires extensive
planning and execution
by the customer to reach a
fully validated state. In the
case of SQL*LIMS® P4™,
the vendor can provide the
main set of deliverables
the customer would need
to eliminate most of the
validation work and go live
with a pre-validated system.
It includes:
- Project management.
Overall management of the
entire effort as a project.
Utilise appropriate planning
and budgeting techniques,
encase the project with the
appropriate project SOPs,
understand and manage the
risks as well as utilise proper
change control procedures.
- Computer systems
validation (CSV) training.
Ensure and document that
all team members involved
in the development and
validation effort have
attended a CSV course.
Ensure this documentation is
part of the validation package
provided to you.
- Requirements. Utilise
industry best practices
to create and complete a
requirements document that
is clear, concise and testable.
- Design and
configuration. Utilise
industry best practices to
design and configure the
system that meets most of
your needs.
- End-user SOPs,
workflows and lifecycle
documentation. Create
standardised SOPs and
workflows utilising
industry best practices.
Also, ensure appropriate
lifecycle documents exist.
For instance, finished goods
manufacturing, stability and
laboratory sample life cycles
are provided for PQ testing.
- Development. Any
development such as
building generic or standard
reports identified in the
design stage should be
created in a fully compliant
and validated environment.
All developers should have
proper CSV training. All
coding should be conducted
under approved code
development procedures
including documented
requirements, designs, code
review and unit testing
normally required.
- Fully documented IQ.
Provide the appropriate
installation qualification
documentation in unexecuted
and executed forms.
- Fully documented OQ. Provide the appropriate
operational qualification
documentation in unexecuted
and executed forms.
- Fully documented PQ.
Provide the appropriate
performance qualification
documentation in unexecuted
and executed forms.
- Documented traceability
matrix. Provide a
bi-directional matrix from
requirements through PQ
testing.
- Validation registry.
Uniquely document all
deliverables as part of the
validation package.
- Validation report.
Create a final validation
report that not only outlines
the validated product and
observed deviations and
resolutions but also the
known product limitations to
help a customer understand
the extent of validation.
LabVantage has offered such
a pre-validated solution
(SQL*LIMS P4) for nearly
two years. It has been
successfully implemented by
a number of customers who
have been able to recognise
the full potential of this
innovative concept. The image illustrates real-world
time and cost savings. On
a LIMS implementation
with an estimated cost
of US$600,000, the
savings would be around
US$480,000 and a start to
go-live timeframe reduced
from eight to 18 months
down to fewer than three
months. SQL*LIMS® P4™
Plug and Play Pharma
Package contains over
3,000 pages of required
documentation that the
customer does not have to
create to be fully validated. |
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Company profile
SQL*LIMS Software has its roots
in an innovative company that
started developing electronic data
systems for laboratory automation
in 1979. Later becoming part of
LabVantage, the first version of
this software was introduced in
1982, and the term LIMS (Laboratory
Information Management
System) was coined.
For more
information, visit:
www.sqllims.com.
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