Why there is no one IT system that fits all the data and process requirements for the pharmaceutical industry?
Figure 1 below shows the core IT systems as aligned to the ISA95 hierarchy model (http://en.wikipedia.org/wiki/ANSI/ISA-95). ISA95 is a standard for integrating software system across the different levels and functional requirements that typical manufacturing organizations require. It was developed to be a best practice method of ensuring that systems are designed to fulfill their purpose successfully and to reduce complexity in system design and interfacing. Practically what this means is to understand that standard software is available and predesigned as “the right tool for the right job”, by using a collection of the best tool these will provide all the functions that are required for your company without having to create software from scratch, this avoids the cost and risk of having to build custom software.
The levels in the above figure 1 are the layers in the company, level 4 is the corporate layer. The corporate layer handles processes across the whole company such as accounting, finance, sales demand and forecasting and distribution. Level 3 is the manufacturing layer that is fulfilled by one or several production sites, for level 3 the important processes are related to the factories themselves such as inventory control, production management and recording, laboratory, quality control and assurance. The lowest levels 0-2 are process control for managing unit operations an example would be the equipment and systems that control the cycles of a mixing tank. The function and data requirement from level 4 to level 0 are clearly very different, for process control it is important for the system to operate in real time as the machine being managed requires instant adjustment and control. The functions the system provides are to be able to build and maintain control recipes and to interface to machinery. At level 3 the production systems are required to manage the complex processes for manufacturing including control of people, material and equipment including all of the required quality assurance documentation and testing.
As above it is considered today to be a modern and best practice approach to provide all the key data and function requirement in standardized systems. With regard to pharmaceutical manufacturing there are 4 key solutions that support the processes from level 4 to level 3 and provide capability to connect to level 0-2 as required. We will explain briefly the 4 key solutions known as transactional systems as they handle discrete business processes.
Enterprise Resource Planning (ERP) is business management software—usually a suite of integrated applications or modules that focuses on Finance, Purchasing, Sales, Planning and logistics/supply chain management. ERP systems are highly mature and well understood as have been developed since the 1980’s and the business processes they support are generally common across many industries. For the pharmaceutical industry there are specific ERP packages available that meet the requirements for both the business and regulations. An important area to be considered for pharma ERP is the need to perform computer validation for any GMP functions and data. ERP systems aim to greatly reduce inefficiencies in the back office processing and reporting need for financial cost controlling.
Laboratory Information Management Systems (LIMS) are designed and developed to support the entire laboratory operation. The typical functions provided are: Sample Management, Environmental Monitoring, Stability Management, Metrology and Method/Procedure Execution. There are overlaps in certain ERP systems with functions provided in LIMS however lab data requirements and instrument connection are typically standard functions in LIMS that are not provided in ERP. LIMS enables lab operations to run faster and more consistently, as sample management and testing can be a bottleneck for the factory then by improving the lab throughput results in shorter cycle time.
Manufacturing Execution Systems (MES) manage and control all data required for the batch record. Typically the functions provided support the complete production starting from receiving materials in the warehouse, through every production steps to the review and approval of the batch and until shipment of the goods from the factory. An MES keeps track of all manufacturing information in close to real time and is able to interface to the ERP for production and inventory data required for purchasing and controlling and to the process control systems for batch execution data and reporting. The typical modules of MES are: Weighing and Dispensing, Material Tracking, Quality Management, Electronic Batch Recording and Equipment. The goal of a MES is right first time production, lean batch recording and review by exception to greatly improve productivity, reduce work in progress and to reduce cycle-time.
Electronic Quality Management Systems (EQMS) manage the mandatory records and business processes for quality assurance and compliance to GMP and quality regulations such as ISO. The main functions that are provided are: Document Management, Training Management, Quality Event Management (including Change Control, Deviation, CAPA, Out of Specification/Trend, Recall, and Complaint), Supplier and Risk Management. Effective quality management is the key foundation of modern international GMP and currently many manufacturers in ASEAN are struggling to understand the regulations and to build and maintain quality systems efficiently that meet the standards. EQMS eliminates the need for the storage and distribution of huge amounts of paper required for quality records and processes. The online and central access to documents and procedures with automatic generation of quality data results in large efficiencies and headcount/cost savings simply by eliminating paper
As above the 4 key transactional systems all differ in the data and the functions that they provide. A more simple way to think about these solutions are that they are designed and built for the purpose and the people that will use them. For example the main users of the MES are production and the quality departments, whereas the users of the LIMS are the laboratory staff. EQMS is focused to the Quality Assurance department and to enable document access to the whole factory and ERP is mostly used by the corporate planning and finance department. All these systems are designed to be standalone meaning that users do not have to learn a large complex system but a simpler tool that fit their needs. By careful integration then data can be entered in one place and available in other systems automatically, however the need for interfacing should be balanced against the cost benefit. For example between the MES and the ERP then a large amount of changing data is required in both systems so the benefit to interface is high, whereas the links between the MES and process equipment are often costly to implement and the value in interfacing the data can be low.
Today there are many standard IT solutions available off-the-shelf for even specialized industries like pharmaceutical manufacturing. The standard functions provided by these systems result in very quick and large benefits to the organization and through an integrated approach then every user can have the right tool for their job. The large multinational pharmaceutical companies do not anymore develop large custom software applications but instead use a collection of appropriate packaged systems across their organization. Today these solutions are available at achievable cost for even small local manufacturers to get the same benefits of compliance and efficiency.