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October 17, 2014

Importance of LIMS Vendor Qualification

Laboratory Information Management Systems (LIMS) offers key features that support a modern laboratory's operation in regulated 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 before implementation.

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 manufacturer.

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:

1.    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.

2.    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?

     It is important to consider such concerns when selecting a product to ensure that the companies' resources are spent wisely.

3.    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.

4.    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.

Infosys has 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:

·         Information Risk Management

·         Software Development Life Cycle Process

·         Computer System Validation Methodology

·         Change Management and Release Management

·         Incident and Problem Management

·         Data Retention and Destruction

·         Quality Assurance

·         Financial capabilities and Relevant Resource availability

·         End User Training strategy

·         Customer Base and Current Engagements

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.

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