By Sumit Gupta, Vice President IT, Hester Bioscience Limited
Hester Biosciences Limited (BSE: 524669) is a WHO-GMP, ISO 9001:2008, ISO 14001:2004, OHSAS 18001:2007 & GLP certified company, that manufactures animal vaccines and health products. Founded in 1997, the company has a market cap of Rs. 153.12 Crore.
In the recent years, there has been a significant rise in te use of computer related systems in the pharmaceutical industry. Many industries have got most of their operations computerized. Not just the big pharma companies, but even about 70 percent of the small and medium enterprises utilize automation in one form or the other. Information Technology (IT) software systems are being increasingly accepted as an essential part of a modern and progressive pharma industry.
There are many different automated software that use drug information, data, and knowledge for their storage, retrieval, and optimal use for problem-solving and promoting safe pharmaceutical care. They facilitate the smooth functioning of pharmaceutical units with improved efficiency, accuracy and decision making pertaining to all pharma processes.
IT in pharmaceutical industry is much different than other industries. The Regulatory Affairs department is an important part of the organizational structure of these companies. These regulations are complex and actively involved in every stage of development of new medicines and in the post-marketing activities with authorized medicinal products.
To implement efficient IT strategy in the company, it is very essential to have an apposite communication between real process owners and IT infrastructure professionals. Process owners play a vital role in ensuring all pharmaceutical products' compliance with regulations that are governing the industry.
It is very difficult to integrate all processes in the system, unless the system is robust enough to capture all the details otherwise it may cause cost to the organization and schedule overrun.
Sometimes it is found that there is a gap between real process owners and IT work.
The reason could be either the possibility of failure of processes to gather or understand the requirement, design, build and manage the system or lack of clarity in defining them to IT professionals by process owners.
So, the biggest challenge is to incorporate various regulatory needs and processes in the system. The organization has overcome this problem by involving real process owners as well as IT infrastructure people during the implementation and execution phase of the system.
In harmony with globalization, the pharmaceutical industry has undergone extensive changes. In order to meet high competition and addressing market reach efficiently and speedily with all regulating compliances, the industry is adopting advanced and latest IT and automation solutions such as Enterprise Resource Planning ( ERP ), Laboratory information Management System (LIMS), Sales Force Automation (SFA), Customer Relationship Management (CRM) and most important Electronic Batch Records (eBR).
ERP integrates all data and processes of an organization. LIMS automates laboratory processes to increase productivity.SFA manages data, controls online movement of goods and manpower, including distribution network for pharmaceutical marketing. CRM helps to manage entire customer life cycle. Above all the most important eBR solution is used extensively that helps to maintain online batch records as industries are focusing on eDocument to reduce their paper work and increase security of data and prevent unauthorized access of documents.
Need of Technological Improvement
Today almost all pharmaceutical organizations have their processes automated. One can find rapid changes in technology or find new up-gradation in short period of time. It is very difficult for IT departments to implement different solutions to maintain and keep it updated frequently and also for organizations as it increases overall cost. Communication and connectivity is also a major problem faced by the industry as most of their multiple manufacturing units might have geographically located in remote area and/or have large distribution network. In that situation, single automated solution which covers all operations can be beneficial to the organization.
Innovation in the Organization
As the global market has become more competitive, the organization needs to drive innovation in their products and services. CIOs play a critical role in developing an IT structure to support innovations. This includes instituting new technology and evaluating how and where they might fit into current organizational needs or add values to business. For this, the company has defined system where employees from all the functional levels are encouraged to come up with innovative ideas which are evaluated, tested and best of them are rewarded.
Towering drug development cost, patent expiration and reduction in the number of best-seller drugs driving pharmaceutical companies to look seriously at IT enabled productivity. The pharma IT strategy can strengthen to improve a business support. Traditional approach of 'Working for Business' is altering into a "Working with Business" model. Pharmaceutical IT processes must support this transformation and also manage mandatory regulatory requirements.
nt for the evolution of all our improvements. Professionals are committed towards patient centric health care delivery, which is the guiding goal of our founder as well as our trustees. Keeping that in mind, we will be working towards improving efficiencies (e.g. reduction in reporting time, waiting period) and patient satisfaction. From the clinical aspect we will be looking at installation of high end technology in some of our key thrust areas.