Controlled Documents: All internally generated documents that have been designated as pertaining to the operation of its quality management system. These include all: policies, procedures, work instructions, records, job descriptions, and organizational charts. Externally generated documents that have been designated as impacting upon the operation of its quality management system or affecting product quality. These include: relevant ISO, EN, ANSI and other standards, relevant medical devices regulations, and client–supplied product specifications, drawings, and instructions.

Good Clinical Practice (GCP): International quality standard provided by the International Conference on Harmonisation (ICH) that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. The guidelines define the standards which trials are conducted including the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. They also include protection of human rights as a subject in clinical trial as well as provide assurance of the safety and efficacy of the newly developed compounds.

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 Laboratory Practice (GLP): a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, cosmetics, food and feed additives and contaminants, novel foods and biocides. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

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.

ISO 9000:2000: The International Organization for Standardization models for quality assurance. ISO 9000:2000 is the model for design, development, production, and installation and servicing.

ISO 13485:1996 and ISO 13488:1996 Standards: The International Organization for Standardization's particular requirements for suppliers of medical devices that is more specific than ISO 9001 and ISO 9002, respectively. ISO 13485 represents a model for quality assurance in design, development, production, installation and servicing. ISO 13488 covers all of the foregoing except design. ISO 13485 and ISO 13488 should be applied in conjunction with the ISO 9001:1994 and ISO 9002:1994, respectively. These are not stand-alone standards. The European version of ISO 13485 and ISO 13488 is EN ISO 13485 and EN ISO 13488 respectively.

ISO 13485:2003: ISO 13485:2003 Medical devices – Quality management systems: Requirements for regulatory purposes replaces ISO 13485:1996 and ISO 13488:1996. This is a stand-alone standard, modelled on ISO 9001:2000, but does not require continual improvement or customer satisfaction.

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.