Back in 2003 and 2007, several FDA reports revealed that about half of 13 factories in the island country of Puerto Rico manufactured contaminated pills. Recent reports show that one of the pharmaceutical companies continued exporting pills that it knew contained small metal particles which were also present inside the bottles the pills were packed in. This was due to the metal content in the drug manufacturing machineries. Hence, it is imperative that the pharmaceutical sector be properly regulated. This is highly essential and justified as medicines can either save someone’s life or make matters worse if proper standards are not maintained in drug manufacturing and information about the medical ingredients and their effects are not known.
Most pharmaceutical companies today are cautious about having their business processes in perfect health. Quality control of raw materials, specifications, formulae, manufactruring processes as well as the finished product is paramount, with exact standards often applying to the receipt and storage of raw materials in addition to the storage and dispatch of finished products. For major players like Pfizer, Schering Plough, Novartis, Merck, and Johnson & Johnson this means that their practices and systems need to be updated to enable the industry to be more agile and responsive and yet maintain a control over complex and costly development and production processes.
Caresoft, a provider of Custom Software Development, Temporary IT Staff Augmentation, and Outsourced QA is well aware that the complexities and challenges of documenting procedures, monitoring processes, authorizations, and managing heterogeneous tracking records are not trivial exercises. Deepak Khare, CEO, Caresoft was early to have a strong understanding of the major transition that is evolving in the pharmaceutical sector and no wonder most of the major players today are knocking at his doors for the same. “In fact the very first customer of ours was from the pharmaceutical vertical. This has given an extra mileage to us in having a better understanding of this vertical,” says Khare.
Caresoft’s customer, M. P. Pharmaceuticals, had complicated systems, long processes, numerous raw materials, and above all, a large amount of human involvement in the process of making medicines. There are frequent audits, and there is very strict demand for quality control data at all stages of the manufacturing process. The company needed a state-of-the-art Laboratory Information Management System (LIMS) to run their labs. However, LIMS does not come cheap. The cost of a typical implementation of LIMS exceeds a minimum of Rs 50 Lakhs. But Caresoft’s Care QCMS has helped its customers in addressing this issue, improving product and services quality, work processes, efficiencies, and morale, while reducing cost, standardizing business by giving it a consistent approach to operations, meeting government purchasing policies, giving confidence to customers that their quality needs will be met, improving customer satisfaction, minimizing fraud, reducing rework and wastage, and meeting quality standards set by different countries. Care QCMS is a Web based system that works on the SaaS model and does not require any client side installation of software or server side installation. Built on XML, XSL, and AJAX architecture, the facility lets the client start Care QCMS within 60 minutes of the subscription approval. For M. P. Pharmaceuticals this was a great relief. The team has been extremely happy with the implementation of Care QCMS. “We would recommend it to any company looking to implement a quality control system for batch manufacturing. The Caresoft Team worked very closely with us to customize and implement it in our unique situation. Not only is their support staff very responsive and knowledgeable but they have also met and exceeded all of our expectations,“ says Mukesh Nema, Director, M. P. Pharmaceuticals. Khare confirms that the product has worked well among midsized companies that are in the range of $5 to 50 million.
But rather than concentrating on one vertical, Khare felt the need to expand the company’s portfolio across various verticals and gain mindshare of the customers in finance, energy, insurance, manufacturing, public sector, telecom, and many more. Winning the mindshare of an Indian government organization itself is one of the biggest testimonials about Caresoft’s confidence among its customers. It was Caresoft’s RTI Soft that was able to grab attention of the public sector.