Barcode: is a machine-readable representation of information in a visual format on a surface. Barcodes store data in the widths and spacings of printed parallel lines or patterns of dots, concentric circles. Barcodes can be read by optical scanners called barcode readers or scanned from an image by special software. Barcodes are widely used to implement Auto ID Data Capture (AIDC) systems that improve the speed and accuracy of computer data entry. Document Management tools often allow for barcoded sheets to facilitate the separation and indexing of documents that have been imaged in batch scanning applications.

Enterprise Resource Planning (ERP):Integration of all data and processes of an organization into a unified system. A typical ERP system will use multiple components of computer software and hardware to achieve the integration of manufacturing, supply-chain, financial, project, customer relationship management, human resource and data warehouse management. A key ingredient of most ERP systems is the use of a unified database, labeling and tracking software to unify data for the various system modules.

Good Distribution Practice: (GDP) Guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs, intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

Good Manufacturing Practice (GMP): Regulatory framework governing the control and management of manufacturing and quality control testing of foods and pharmaceutical products. An important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Additionally, GMP requires that all manufacturing and testing equipment have been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).

Good Automated Manufacturing Practice (GAMP): is a set of guidelines laid down by International Society of Pharmaceutical Engineering (ISPE) covering the use of automated manufacturing and electronic tracking systems within the pharmaceutical industry.

Logistics: is the art and science of managing and controlling the flow of goods, energy, information and other resources like products, services, and people, from the source of production to the marketplace. It involves the integration of information, transportation, inventory, warehousing, material handling, and packaging. The operating responsibility of logistics is the geographical repositioning of raw materials, work in process, and finished inventories where required at the lowest cost possible.

Material Requirements Planning (MRP): is a software based production planning and inventory control system used to manage manufacturing processes. An MRP system is intended to simultaneously meet 3 objectives: (a) Ensure materials and products are available for production and delivery to customers; (b) Maintain the lowest possible level of inventory and; (c) Plan manufacturing activities, delivery schedules and purchasing activities.

The International Organization for Standardization (ISO): an international standard-setting body for industrial and commercial standards composed of representatives from various national standards bodies.

Radio-frequency identification (RFID): is an automatic identification method, relying on storing and remotely retrieving data using devices called RFID tags or transponders. An RFID tag is an object that can be attached to or incorporated into a product, animal, or person for the purpose of identification using radio waves. All RFID tags contain at least two parts. One is an integrated circuit for storing and processing information, modulating and demodulating a radio frequency (RF) signal and perhaps other specialized functions. The second is an antenna for receiving and transmitting the signal. The RFID tag can automatically be read from several meters away and does not have to be in the line of sight of the reader. The current thrust in RFID use is in supply chain management for large enterprises. RFID increases the speed and accuracy with which inventory can be tracked and managed thereby saving money for the business.

Supply chain management (SCM): Process of planning, implementing, and controlling the operations of the supply chain with the purpose to satisfy customer requirements as efficiently as possible. Supply chain management spans all movement and storage of raw materials, work-in-process inventory, and finished goods from point-of-origin to point-of-consumption. Supply chain management must address the following problems: (a) Distribution Network Configuration: Number and location of suppliers, production facilities, distribution centers, warehouses and customers; (b) Distribution Strategy: Centralized versus decentralized, direct shipment, Cross docking, pull or push strategies, third party logistics; (c) Information: Integrate systems and processes through the supply chain to share valuable information, including demand signals, forecasts, inventory and transportation etc and; (d) Inventory Management: Quantity and location of inventory including raw materials, work-in-process and finished goods.

21 CFR Part 11: Section of the Code of Federal Regulations that deals with the FDA guidelines on electronic records and electronic signatures in the United States. Part 11 as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries (not including food manufacturers) to implement controls, including audits, validation systems, and documentation for software and systems involved in processing many forms of data as part of business operations and product development.