IT@Pharma Special www.expresspharmaonline.com 16-30 June 2010
“Deliver More, Deliver Excellence!”
Today, in the market there is a number of software companies have come up with LIMS solutions of varying success. Caliber Technologies have developed its key product for multiple solutions and in return it gets maximum returns from its key product CaliberLIMS. Sathya Sekhar Surabhi, Chief Executive Officer, Caliber Technologies explains needs of such products in the pharma industry to Usha Sharma….
Why do Indian pharmaceutical companies need to adopt software tools for information management?
It is a very good and pertinent question. If you look at the pharma industry journey, it has a great evolution over a period of time, from the days of testing a batch at the end for the release into the market, to the current trend of controlling every piece of the operation to ensure quality goods are produced consistently. So logically, the data generated in the process has a humongous growth. On the other hand, regulatory bodies worldwide are expecting the pharma companies to analyse each possible risk that would affect the quality and take corrective and preventive actions. In the process, quality control (QC) and quality assurance (QA) departments end up generating and compiling huge amounts of data at each point. This is not only a humanly daunting task, but it is highly time consuming, error prone and eats up valuable time of an analyst and senior management. So this should be a fit case for adopting software tools for managing the data and staying ahead in the market.
How is your application for the pharma industry is different for other industry specially for the regulated market?
Yes, it is different from industry to industry. By design pharma industry has a zero tolerance to errors. An error could impact quality of human life. So the process of building a software application for pharma operations is highly process driven and should meet the regulatory requirements of traceability and ownership of an action performed. Even the applications should meet the ’Predicate rules’ requirements and enable the users to comply with regulations. Implementation process is also very stringent and should meet all the guidelines /requirements published in GAMP5. So it requires special attention right from the design stage to the delivery stage and also in the way it is maintained. Caliber as a team is specialised in complete lifecyle of the applications for pharma industry ie. design, develop, deliver and maintain to the regulatory standards.
How much business do you draw from the pharma vertical?
Our maximum business comes from pharma or can say pretty much everything. More than 90 percent of our revenue comes from the Pharma vertical. We are highly specialised in designing software solutions and products for pharma practice that effectively address business pain points readily. This brings an enormous value to the table as all our solutions are quick to implement, easy to maintain and more importantly meet all the regulatory requirements readily. As of now, pharma companies are keeping us busy and we are expanding more into that. Generally, information generated in a pharma industry tends to become huge. Similarly, the information handled in an analytical laboratory and the QC lab can be daunting. This could be information on a number of master items and a lot of data about a variety of transactions, and also the outputs obtained after processing both these categories of data. The data needs to be securely preserved for long periods of time. Most of it needs to be frequently retrieved not only for internal use but also to meet stringent regulations, inspections and audits. Paper based information containers are damage prone and physical handling can become extremely tedious. Robust software tools and dependable information technology enabled services are the only alternatives, to handle the data safely and in a demonstrably secure environment. Such tools are called Laboratory Information Management Systems (LIMS).
What are the challenges need to be addressed when implementing IT-based solutions in the pharma industry?
The first challenge that needs to be addressed by the industries migrating from manual systems or primitive systems to modern software tools is to retain the utility of the data chronicled and archived in legacy formats. If the new software tool fails to read and use it, it would have to employ effective interfaces. This may not always be possible and / or cost and time effective. Working on secure computer systems will demand and ensure higher accountability, often making the employees uncomfortable. The other challenge therefore may be the resistance from some sections of staff. Employees need to be counselled, convinced, encouraged and trained to adapt to the new technologies by acquiring new skill sets. This could be both time and money consuming, with incentives having to be given to the existing employees or recruiting already skilled resources. Conservative managements tend to hesitate to take the risk or accept the costs, but once they take an informed decision, they will soon come to know and enjoy the enormous advantages of software solutions, thereby increasing the performance and accountability levels.
How does an IT application works in the Indian pharma industry?
An IT application automates the otherwise tedious, repetitive and error prone manual work to a large extent. This increases the output of individuals while taking away the human fatigue and loss of concentration and human errors. Compliance with the regulatory norms will be easy and demonstrable.
How are IT-based implementation tools in pharma industry different from other industries? What product modification needs to be done to make the IT tools successful?
A software tool built strictly on the basis of well understood requirements of the individual target users will not be much different whatever be the industry. However, unlike in other general manufacturing industries, Pharma industry deals with health and the quality of human life. Hence, the implications are much more serious and the requirements much stringent. The tool as well as the management must be accountable to regulatory regime.
What regulatory requirements need to be kept in mind while designing IT solutions for the pharma industry?
As far as the pharma industry is concerned, the mother of all regulatory authorities is the United States Federal Drug Administration (US FDA). They have promulgated very strict regulatory norms, and accountability of electronic records with electronic signatures that are regarded as standards worldwide. In addition, every government will have its own authorities to enforce implementation of these standards.
How difficult it is for IT providers to design solutions for different countries / clients?
This is one typical challenge we have in India compared to many other countries. India has established itself as leading supplier of pharma products to worldwide. While supplying to multiple countries the biggest challenge is to meeting the standards of different countries and meeting all the documentation and regulatory standards. Though the requirements and the implications in providing software solutions for pharma industries is quite daunting, there are a number of software companies have come up with LIMS solutions of varying success. LIMS designed for the kind of operations is much more complex, in terms of meeting multiple standards and thereby intricacies involved in meeting them. The success of a solution is commensurate with the ease of mastering operations, and the speed of return on investment. At Caliber, we mastered that art of delivering highest value. Today, Caliber LIMS, stands among the global top ten popular LIMS brands. Caliber LIMS has marked its success in the Pharma Industry, with its USP of quick learning curve and fast return on investment. We stand to our product slogan/ punchline “Deliver More, Deliver Excellence!” We strive to deliver more than the customer expectations and excel in whatever we deliver. With our CaliberLIMS, we sincerely believe our users would be in a position to deliver significantly more and with all controls, checks and balances in place, they will deliver excellent quality work.
How does IT implementation in the pharma company drive sales, and improve the bottom line?
With the commissioning of LIMS, the time, tedium and the vulnerability of routine manual record keeping, retrieving and processing are significantly reduced. The stress on the laboratory personnel is remarkably reduced. The time taken for documenting the analysis will be reduced and the number of samples analysed increased. An analytical lab equipped with an effective LIMS (like for example CaliberLIMS) will increase the turnout tremendously by taking away the tedium and human errors, and by increasing accountability. This contributes greatly to QA of the products, and its demonstrability inspires confidence in the customers, leading to larger order books, in geometric progression. CaliberLIMS assures do right the first time, so lot reduced reworks, lesser reviews, and quicker reports. In fact our LIMS users spend very less time preparing for audits as they are ready for audit any time. A good sleep- a great value addition we give to all our users.
How do these IT tools impact production schedule inventory control and overall productivity of the pharma company?
A good LIMS will have specially designed resource management functionalities, built into it, affording on-line inventory control of many resources. A good LIMS will also integrate into the firm’s existing ERP or SAP systems, to streamline the information flow. These facilities ensure improve inventory control and enhance productivity.
Other than CaliberLIMS, what other solutions do you offer to the pharma industry?
CaliberLIMS, our flagship product has made huge progress in terms of the functionality it covers different applications. It can interface with over a period of time. Currently the solution we deliver has grown manifold. In addition to CaliberLIMS we have an extremely good solution for training that is way above the products available in the global market.
We have recently completed our beta testing and launching an extremely innovative product for pharma batch records management electronically. This is scalable product simple management to fully automated execution. Our beta test site users are highly delighted and the unanimous opinion is that it is saving them huge efforts, time and money. We should be launching this soon into the market.