LIMS consultation sure to grow

LIMS consultation sure to grow

Vikrant Rane, Director, Global Business Development, North East Pharma speaks to Usha Sharma on the growth prospects of LIMS consultancy services

Please explain nature of consultation business worldwide?

Presently, the focus area of business is on providing concept, configuration and validation services for Laboratory Information Management System (LIMS) projects. Assisting LIMS projects, while designing its requirements and giving Computer System Validation (CSV) support to ongoing projects. Consultants are also responsible for monitoring the progress as appropriate within domain of responsibility such as, compliance and audit requirements and other quality standards and risk assessment for events of the application.

Could you comment, on how the pharmaceutical and biotech consulting segment arose and how it is growing?

The pharma and biotech consulting segment is already existing for past two decades or more in the developed nations; US, Europe and in India as well. Consultation services within pharma industry in terms of engineering, compliance with regulatory authority has its presence in India and around the world. The pharma drugs will continue to be in demand, regardless of economic conditions which will demand continuous involvement of information technology (IT) sector. The presence of IT in pharma industry has fuelled growth of consultation at a tremendous rate.

As the experts in the Gartner Dataquest report states, in 2000, external services spending represented 53 percent of total external spending for the US pharma industry. Whereas, hardware industries spending accounted for 18 percent followed by network equipment spending at 15 percent and software spending at 14 percent of external spending for the industry. The presence of IT in every industry has been rising for past two.

Hence, the sector of LIMS consultation is sure to grow in coming years to cater this highly regularised industry. The global pharma players would like to standardise the systems with regards to regulatory and quality requirements. Across the sites impact of centralised strategic decision making is evident. To complete this mammoth task, external help is needed and that’s how consultancy will grow to keep up with the innovation.

What does a consultant bring to the table that an employee does not?

As far as LIMS consultation is concerned it is the need of the future. This area of consultation is sure to grow. The expertise level or I would say the levels of understanding regarding clients needs are far better than an employee to employer relation. A consulting firm focuses on client’s objectives more effectively within given or minimum timeframe. An independent review of full quality system or conducting of partial audits to avoid possible conflict of interest can be achieved by consulting firms.

Consultancy services help ensure clients of regulatory compliance and operational efficiency due to their vast experience with the application product.

Is this practise is well accepted by MNCs?

Consultancy in multinational companies (MNC) is well accepted practice. As far as pharma industries are concerned they have annual contracts with the vendors for their high end or new technology; production and laboratory equipments. Till the time employees of the organisation become experts on the equipments, consultation is provided either in the form of fixed time frame or on as need arise.

How is it helpful to the big and small players?

Whether big or small players, eventually LIMS requirements are going to be the need of the future. As the instrumentation industry has seen its growth over a period of 15 to 16 years in pharma industry due to technology advances. I would say the same rule applies to LIMS as it is an integral part of the quality system. LIMS increases the productivity by reduction in man hours, which in turn gives more opportunity for creativity within the organisation in terms of development. This is applicable to big and small players who are ready for constant change.

Does regulatory involvement needed in business forum? Is it proactive?

Pharma industry is the most regularised industry compared to other industries. The business forum associated with this industry is well aware of the regulatory requirements. Business forum is more proactive in case of compliance or regulatory issues involved due to new technologies.

On 20th August 1997, US Food and Drugs Administration (FDA) made 21 CFR part 11 effective. The easy accessibility to data of pharma organisation with e-submissions has reduced time and auditing became easier. The associated industry has reacted to this very proactively. To give an example, Labware LIMS has outperformed other vendors in terms of audit trails, time stamps and seamless up-gradation to new versions with minimum validation requirement to the application. They have set of expertise within the agency; as well as their client’s feedback to make the necessary updates as and when applicable.

What are the strengths and weaknesses of the consultancy business?

Strength means consultants provides specific expertise and bring broad base of experience not normally available internally. As against weaknesses are they may be considered too costly but one has to think of the potential savings of experts doing the job more quickly and correctly with fewer errors. Of course assumes that the consultants are knowledgeable and technically capable.

Does consulting firms get affected due to instability of world economic market?

Yes, they do to some extent but not always. As the elderly population is expected to rise—the single largest group of prescription drug users grows. This in turn keeps the pharma or biotech industry in best of its health. Consulting firms must have domain expertise in the business pressures, regulatory issues and technological needs that affect the receptivity of the industry.

If you provide better priced and competitive solutions of services you are in for long relations. No quick fixes; which may spoil the relation with the customer due to intermittent failures. More focus towards creativity or out of the box thinking will always provide better business for long term.