IT@Pharma Special

IT@Pharma Special

Need to adopt collaborative enterprise systems to be globally competitive

India’s pharmaceutical industry ranks as a frontrunner among the country’s science-based industries with wide ranging capabilities in the complex fields of drug manufacture and technology. The industry has been growing at an impressive CAGR in excess of eight-nine percent, and will touch $10 billion by 2010. Presently, the industry is around $8 billion strong with export revenues accounting for 35-40 percent. While the industry is making efforts to emerge strong in the drug research segment, its challenge originates from the need to consolidate its position as a globally competitive producer of quality drugs, aligning with global norms in terms of technology, quality control, and best practices, among others. In the current environment, the bottom line is being threatened by increasingly stringent regulations, government price controls, and cost pressures. There is also a need to outsource without compromising on quality or local compliance efforts. Thus, the goal is to move towards electronic documentation, ensuring real-time traceability and statutory compliance. It now has become inevitable for pharmaceutical companies to leverage enabling technologies, which include automation systems and enterprise solutions, and integrate them so as to form a collaborative enterprise. This enables corporate, financial, process control, production planning, lab operations and supply-chain decisions to be all synchronized.

Today, barriers to information still exist between different operations management and enterprise management systems, resulting in little integration between the real-time plant world of control applications with the transactional world of Purchasing, Sales, Accounting, Quality Control Systems, Vendor Rating, Raw Material Data Management, Laboratory Systems, Resource Management, Logistics, to Marketing and Distribution. End users need to consider the impact that these barriers to information have on productivity, business opportunities, lifecycle costs, and the realization of a strategy for operational excellence in today’s plants and factories. These fundamental processes determine collaboration needs. Companies must address these areas when considering an infrastructure to support Collaborative Manufacturing Management, and in turn, this must support connectivity within the enterprise among various functional departments. Older or bespoke IT systems also hinder the adoption of available new technologies that provide real collaborative advantages, such as ERP applications and advanced production management applications. Therefore, manufacturers need to take a proactive stance regarding their aging IT systems, or they will quickly become very tedious and overwhelming. As pharma companies in India are becoming increasingly global in their operations and market outlook, they also are forced to deal with global competition.

A collaborative relationship between these domains is desirable so that the manufacturers’ need of a single monolithic system for their organisational ecosystem is met. Simultaneously, regulatory and business requirements are also converging to a common set, encompassing all types of control, from continuous process, batch, logic, and motion control. Regulatory industries such as Life Sciences and Pharmaceuticals can definitely benefit from the collaborative approach. Collaboration driven by enterprise solutions allows for a more proactive and businesslike approach for manufacturers to achieve regulatory compliance. This helps to drive current and future regulatory requirements to be compatible with business operational excellence methodologies. In the pharma industries, the relationship between operations management and enterprise is now at the forefront. Tectura believes that a collaborative enterprise involving compliance to regulations and enforcement of policies is converging to a single common set for all regulated products and industries.

The quantifiable benefits incurred include:

Enhanced visibility

Integrating disparate information systems throughout the company, company will be able to gain 100 percent visibility into the manufacturing side of the business. Helping the company make better informed, real-time decisions, and enabling increased plant throughput, contained costs and improved delivery performance. Gaining visibility into the manufacturing pipeline with a fully integrated system, pharma manufacturing companies can achieve tighter controls over the sales-order process, enabling better decision-making.

Optimise manufacturing resources to expedite profitable, new product introductions With escalating development costs for new product development, life sciences and pharma companies constantly strive to bring products to market quickly, yet control costs by monitoring operations at a detailed level, keeping a close watch on yields and labor, tracking raw material usage, and planning production shifts to maximise capacity. . ERP for Pharma provides visibility across all areas of the organisation from finance to manufacturing, speeds the flow of goods, eliminate waste due to costly shelf-life expirations and returns, optimise production operations, and gain increased efficiency to meet new product introduction demands, while keeping costs at a minimum.

Efficient lab operations and increased compliance

Regulatory agencies and government departments place specific requirements on pharmaceutical manufacturers when implementing manufacturing systems. A collaborative enterprise will support GMP requirements including electronic quarantines, quarantine release by user and material type, printed material control/obsolete components, batch control/segregation, batch tracking, and drug and hazardous reconciliation. Also easier access to data for both internal and external business customers, complete records preservation for internal as well as regulatory compliance purposes, improved performance of laboratory information management process. Total availability of monitoring and data collection during all manufacturing phases helps with 21 CFR Part 11 compliance.

Improve production planning and inventory management

Life sciences and pharma manufacturers handle active ingredients that are often very expensive in small quantities so they are often reused and/or recycled several times. A collaborative enterprise helps minimise over-runs and short-runs, and uses shelf life tracking to consider expiration dates during production and into the distribution process. One can also centrally manage co-products and by-products in your formulas or recipes and always know the correct inventory status for any given item.

Increased inventory control

With inventory control processes in place, the company will be able to accurately manage the complete product lifecycle – from raw materials to finished goods. As a centralised information repository, companies will have the ability to execute detailed product costing, just-in-time planning and fulfillment and the analysis of yield.

Gain better business insight

Accurate information about business operations is an essential requirement for business success, especially in challenging environments. A collaborative enterprise helps manage business confidently with quick access to critical operational and financial data. It also delivers meaningful insight to individuals and teams across your organisation. With access to real-time data and a wide range of analytical and reporting tools—including graphical displays, online analytical processing (OLAP) cubes, and Web-based delivery options—people can make informed, confident decisions that help drive business success.

Tectura a worldwide provider of business consulting services for Microsoft Dynamics ® NAV and AX enterprise solution has developed its industry solution, Tectura® Life Sciences based on Microsoft Dynamics® NAV, which provides industrial and trading companies from the pharmaceuticals, fine chemicals, cosmetics, biotechnology, medical technology, and dietary supplement industries with a collaborate enterprise solution designed to meet the requirements of the industry, including regulatory requirements.