The growth of competition on the market, as well as strict legal regulations make pharmaceutical companies face the challenge of deploying cutting-edge IT solutions. This is the only way to comply with the requirements of regulators, streamline manufacturing processes, and speed up product launches.
IT Support for the Pharmaceutical Industry
The key issue for the pharmaceutical industry relates to the regulations concerning top security standards (GMP), from new product research, through drug registration and manufacturing, to actual distribution, promotion and recording of undesirable effects of substances available on the market. Good Manufacturing Practice (GMP) standards govern the pharmaceutical industry. It includes actions that must be taken, and conditions that must be fulfilled during the manufacturing process, so that drugs and medical products to be distributed are of top quality.
GMP also imposes requirements on IT systems. If an IT system does not undergo validation, then, according to the regulations, it is not a credible source of information. It is not known, whether the system is able to, e.g., efficiently manage the manufacturing system. Though the company may continue using the system, at the same time it must deploy a standard quality assurance system. In practice, this means the company must keep hard-copy documentation of sales or procurement procedures, instructions and records.
Logistics on Short Notice
The fact that companies need to deploy and use IT systems is proven by the example of logistics solutions. Logistics, defined as a complex process of delivering the product onto the market, is inextricably linked to the manufacturing process, distribution channels, business environment and competition. Considering the process of designing logistics and the supply chain, especially in this industry it is important to link several aspects together, such as choosing the right logistics equipment and IT tools, in a professional manner.
The pharmaceuticals distribution process is a cycle of complex actions that require highest security standards and constant information sharing. Keeping full control over the system, and having insight into even the smallest components determines the quality and efficiency of operations. Today the market forces distributors to provide short delivery times even for single packages of pharmaceuticals. Institutions supervising sales of pharmaceuticals force companies to meet defined, strict transportation requirements. Each participant of this market has their own expectations regarding communications concerning the available portfolio of products, submitting orders, handling payments and reimbursements from the National Health Fund. All these factors force distributors to develop complex logistics systems helping them to comply with these requirements. "IT solutions are simply a must for everyday operations of companies from the pharmaceutical sector. For example, let us take an average pharmacy, which in principle does not have any pharmaceuticals in stock, where the distributor deliver the drugs 2-3 times a day. Every pharmaceutical wholesaler or company must operate an efficient system supporting transport management processes, ensuring, among others, real-time access to order statuses and centralized control over order completion processes," says Janusz Budek, Software Representative, Prosper S.A., a large pharmaceuticals distributor in Poland. Transport of drugs is one of the core components of this complicated process. A disorganized or poorly designed mechanism might be a serious problem for the company and patients.
Due to strict legal and organizational requirements, the companies are required to minimize the manufacturing risk. This makes them certain that products launched into the market are not harmful, nor defective. Thus, all the processes must be documented. Companies should be able to prove that they control the production and logistics risks.
How does efficient logistics work?
ControlTransport from Consafe Logistics is an example of a solution optimizing all logistics processes within a company. It is a mobile system supporting transport management processes, ensuring real-time access to order statuses and centralized control over order completion processes. "The main purpose of the system is to streamline forwarding and transportation order delivery," says Marcin Michalski, Project Manager, Consafe Logistics. "The system exerts control by tracking a specific shipment (order) on the level of a selected container, as well as the entire shipment, ensuring much easier operation and shorter pharmaceutical delivery times".
Cutting-edge logistics solutions allow for constant monitoring of temperature inside vehicles that carry medicines and containers with medicines. Each deviation from the preset threshold is communicated via a special alert. The solution is integrated with temperature reading modules. A message is displayed immediately upon reading incorrect parameters.
Choosing a System Provider
When identifying IT system providers, pharmaceutical companies should consider a few criteria. A key element is the ability to customize the system to the requirements of the pharmaceutical market, its specific nature, regulations and the competitive environment. An efficient IT system can be easily aligned with the processes within the company. Moreover, every experienced IT manager must be aware that the value of the system should be measured with specific indexes: system delivery and maintenance costs, deployment duration and ROI.
And an important piece of advice – it is worth choosing companies employing consultants with experience in local markets, who understand the needs and expectations of the management board and IT manager within the context of the company’s business operations.