Laboratory Information Management Systems (LIMS) offers key features that support a modern laboratory's operation
environments. LIMS can save vast
amounts of time and dramatically improve productivity within the workplace. LIMS vendors
are growing at fast due to expanding LIMS market. Before the Pharma
manufacturer purchases the LIMS product, it is recommended to conduct an audit of
the vendor. Post purchase it a good practice to conduct re-evaluation after 1-2
years to ensure their Quality Management System continues to be followed since
they will be sending patches and updates of their product.
Making the wrong choice
of the vendor can increase the total cost of deployment 2-3 times of the
original estimates and can result in a failed project altogether. Most of the
unsuccessful LIMS implementations are having root causes in and around
inefficient budget planning, improper project management and improper Vendor selection for
implementation. Consequences of improper vendor selection are as follows:
1. Inaccessibility of basic source code required for
customization: Typically none of the
LIMS products can be used as-is out of the box, they need some customizations
and configurations. The vendors share
the Application Programming interface (API) which makes the configuration of
the LIMS package difficult. It increases dependency on vendors for subsequent
configurations / customizations.
2. Integration with current IT landscape (ERP, CRM, SCM etc.):
LIMS COTS products available in the market do not properly integrate/interfaces
with other landscapes which create need for extensive customizations.
3. Exponential increase in cost of Validation: Due to
increase in customizations the validation requirements increase which
exponentially increases cost, efforts and resource requirements for validation.
4. Insufficient coverage of regulatory requirements: For
regulated Pharmaceutical manufacturer, adherence to regulatory compliance to 21
CFR part 11, GxP, EUGMP annexure 11 etc. is mandatory which is overlooked by
some of the LIMS Vendors. Later it is achieved with significant cost and effort.
5. Inadequate quality documentation of SDLC and CSV: Vendors
normally do not share the Functional Specifications/Software Design
Specifications/User requirements specifications which mandates the Pharmaceutical
Manufacturer to create their own specifications for validating the
customizations in LIMS package implementation. This becomes a major bottleneck
for functional testing as the package is not properly tested and validated
6. LIMS Vendor may not be available for upgrade or future
support of LIMS in case of any customization or development requirement if
financial credibility or future plans of vendor are not understood properly
during Vendor selection.
7. LIMS is implemented with less functionality which is not
satisfying all User Requirements scope objectives of Pharmaceutical
8. LIMS is adopted with superfluous functionalities just
because those are available in LIMS package.
9. Schedule slippages due to improper project planning and
resources from vendor side.
These issues can be avoided if the customer evaluates and
assess all these points before purchasing the product from the vendor. The
Pharma manufacture is responsible for any lapses in the regulatory requirements
and is accountable to regulatory authorities. Thus vendor selection is as
important as the technology selection and sufficient due diligence is warranted.
Important factors to be considered during vendor
selection are: Financial credentials,
Future product plans of vendor, Technology,
Platform, Product demonstrations, Implementation cost and time, Validation
strategy complying all applicable regulations, SDLC & CSV documentation,
LIMS support quality, and the consultant credibility.
When selecting a LIMS Product, it is important to select preferred and
reputed vendor whose LIMS package is 'best fit' for your requirements. Some of
the key points checked during vendor qualification are as below:
Business Process Evaluation: BPE is used primarily to define the
role of LIMS within the organization. User Requirements must be clearly
specified, concise and well understood.
Financial Evaluation process: This process should include viability studies having below criteria:
o What is the state of financial health of the company
supplying the products?
o Will they be around in 2 years when you need to upgrade?
o What are the future plans for the company? Are they
planning on shifting business strategies, rendering your purchase obsolete?
is important to consider such concerns when selecting a product to ensure that
the companies' resources are spent wisely.
Vendor Survey demonstration process: A selected vendor should be invited to demonstrate a
product taking into account the specific requirements. This process aims to
identify the most proficient supplier and also helps as information-gathering
tool. It gives the customer ideas of what can be done and educates them in what
cannot be done so that Pharmaceutical manufacturer can amalgamate and prepare
single proposal. As customization is an expensive way of achieving a 'correct
fit'. By this way, LIMS matches your criteria as far as possible with little
need for customization.
Vendor Validation Process: As part of the vendor audit, the customer should thoroughly assess the
validation methodology of the vendor. It should also check their change
management and release management process. This will give an assurance to the
customer of the processes and regulations they follow to develop their products
and whether they meet their criteria. Any observations or recommendations
during this assessment should be closed through CAPA by the vendor before start
of contract. This will also help the manufacturer in determining their
validation strategy during implementation.
developed a comprehensive checklist and guidelines based our experience to help
our clients select the right vendor for their LIMS requirements. The guidelines
comprises of control points which are derived from FDA and EMEA regulations and
helps in successful LIMS implementation eliminating all consequences mentioned in
earlier sections of this blog. At a high level our evaluation checklist and
guidelines can be categorized into following sections:
Software Development Life
Change Management and
Incident and Problem
Data Retention and
and Relevant Resource availability
End User Training
Customer Base and Current
There are many LIMS COTS products available in market
which have almost similar functionalities and have very little difference.
Around 80% functionalities are same and vendor selection will depend on the 20%
functionalities which differ from other vendors. The manufacturer should take the
required time to make sure that a reputed vendor with good credibility and at
the same time cost effective is selected to provide a solution that best "fits"
his requirements. Infosys with its experienced pool of consultants can help you
in this journey by helping you to select the right product and be your
implementation and validation partner thus minimizing the miseries during LIMS integration.