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Business Process Standards for the Life Sciences Industry

EPCglobal HLS  
EPCglobal is a standards consortium that is focused on improving efficiencies in the value chain through the use of Radio Frequency Identification (RFID) technologies. While EPCglobal is known more for their work in the retail industries, it also has a prominent Health and Life Sciences (HLS) Industry Action Group (IAG).
The HLS IAG attempts to define industry-specific requirements for health and life sciences, it does not write any specifications. In the EPCglobal process, the HLS requirements are harmonized with other industries. Eventually other technical groups in EPCglobal produce the actual technical specifications, which can be used across multiple industries. Due to various state laws that have been passed in the United States the HLS IAG has been very active in producing important requirements for RFID specifications. SAP is very active in promoting the adoption of RFID and other Real World Technologies.

Manufacturing Standards for Life Sciences

There are a number of manufacturing specifications that are a consideration for companies in the health and life sciences industry. These manufacturing specifications are used across a number of industries specifically with respect to process control and interoperability.

ISA 88 is an international standard focused on enabling industries to manufacture batches of products, such as drugs, in a flexible, yet interoperable manner. The standard defines mechanisms by which companies can describe the manufacturing process and control the equipment used during the manufacturing process.

Manufacturing Enterprise Solutions Association (MESA) is an organization that consists of manufacturers, system integrators, consultants, and information systems vendors focused on leveraging technology to meet the needs of manufacturers. This includes extended support of continuous process industries such as the oil and gas industry and the petrochemical industry. 

The World Batch Forum (WBF) was founded in 1994 to promote the exchange of information related to the management, operation, and automation of batch process manufacturing. This includes key specifications like B2MML (Batch to Manufacturing Markup Language) which are used to communicate information required to control the production of various life sciences products.

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