Glossary

Common Business Oriented Language

A high-level programming language intended for use in the solution of problems in business data processing.

Consolidated Omnibus Budget Reconciliation Act

Certificate of Conformity

Cyclic Olefin Copolymer

A bacterium of round, spheroidal, or ovoid form, including micrococcus, staphylococcus, streptococcus, and pneumococcus.

Code of Design

Critical Operating Data

Chemical Oxygen Demand

The amount of oxygen needed to completely oxidize all oxidizable organic and inorganic substances in water.

Committee on Data for Science and Technology (Comité pour les données scientifiques et technologiques)

(IEEE) An independent review of source code by a person, team, or tool to verify compliance with software design documentation and programming standards. Correctness and efficiency may also be evaluated. Contrast with code inspection, code review, code walkthrough.

A software tool which examines source code for adherence to coding and documentation conventions.

Source code is text written in a computer programming language. Changes to this code are considered code changes and in validated systems must be done in accordance to strict procedures.

(Myers/NBS) A manual (formal0 testing (error detection) technique where the programmer reads source code, statement by statement, to a group who ask questions analyzing the program logic, analyzing the code with respect to a checklist of historically common programming errors, and analyzing its compliance with coding standards. This technique can also be applied to other software and configuration items. Synonym: Fagan Inspection.

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The CFR is divided into 50 titles that represent broad areas subject to Federal regulation. Each title is divided into chapters that usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas. Large parts may be subdivided into subparts. All parts are organized in sections, and most citations to the CFR will be provided at the section level.Title 1 – General ProvisionsTitle 2 – (Reserved)Title 3 – The PresidentTitle 4 – AccountsTitle 5 – Administrative PersonnelTitle 6 – (Reserved)Title 7 – AgricultureTitle 8 – Aliens and NationalityTitle 9 – Animals and Animal ProductsTitle 10 – EnergyTitle 11 – Federal ElectionsTitle 12 – Banks and BankingTitle 13 – Business Credit and AssistanceTitle 14 – Aeronautics and SpaceTitle 15 – Commerce and Foreign TradeTitle 16 – Commercial PracticesTitle 17 – Commodity and Securities ExchangesTitle 18 – Conservation of Power and Water ResourcesTitle 19 – Custom DutiesTitle 20 – Employees’ BenefitsTitle 21 – Foods and DrugsTitle 22 – Foreign RelationsTitle 23 – HighwaysTitle 24 – Housing and Urban DevelopmentTitle 25 – IndiansTitle 26 – Internal RevenueTitle 27 – Alcohol, Tobacco Products and FirearmsTitle 28 – Judicial AdministrationTitle 29 – LaborTitle 30 – Mineral ResourcesTitle 31 – Money and Finance: TreasuryTitle 32 – National DefenseTitle 33 – Navigation and Navigable WatersTitle 34 – EducationTitle 35 – Panama CanalTitle 36 – Parks, Forests, and Public PropertyTitle 37 – Patents, Trademarks, and CopyrightsTitle 38 – Pensions, Bonuses, and Veterans’ reliefTitle 39 – Postal ServiceTitle 40 – Protection of EnvironmentTitle 41 – Public Contracts and Property ManagementTitle 41 – Public HealthTitle 43 – Public Lands: InteriorTitle 44 – Emergency Management and AssistanceTitle 45 – Public WelfareTitle 46 – ShippingTitle 47 – TelecommunicationTitle 48 – Federal Acquisition Regulations SystemTitle 49 – TransportationTitle 50 – Wildlife and Fisheries

Chapter I – Food and Drug Administration (FDA), Department of Health and Human Services (Parts 1 – 1299)Subchapter A - General (Part 1)Part 11Electronic records; electronic signatures (related requirement)Subpart A – General ProvisionsSubpart B – Electronic RecordsSubpart C – Electronic SignaturesPart 50Protection of human subjectsPart 56Institutional Review BoardsPart 58Good laboratory practice for nonclinical laboratory studiesSubchapter B - Food for Human Consumption (Part 100)Subchapter C - Drugs – General (Part 200)Part 200GeneralPart 201LabelingPart 202Prescription drug advertisingPart 203Prescription drug marketingPart 205Guidelines for State licensing of wholesale prescription drug distributorsPart 206Imprinting of solid oral dosage form drug products for human usePart 207Registration of producers of drugs and listing of drugs in commercial distributionPart 208Medication Guides for prescription drug productsPart 210Current good manufacturing practice for finished pharmaceuticals (human and animal)Section 210.1 – Status of current good manufacturing practice regulations.Section 210.2 – Applicability of current good manufacturing practice regulations.Section 210.3 – Definitions.Part 211Current good manufacturing practice for finished pharmaceuticals (human and animal)Subpart A – General ProvisionsSubpart B – Organization and PersonnelSubpart C – Buildings and FacilitiesSubpart D – EquipmentSubpart E – Control of Components and Drug Product Containers and ClosuresSubpart F – Production and Process ControlSubpart G – Packaging and Labeling ControlSubpart H – Holding and DistributionSubpart I – Laboratory ControlsSubpart J – Records and ReportsSubpart K – Returned and Salvaged Drug ProductsPart 216Pharmacy compoundingPart 225Current good manufacturing practice for medicated feeds (animal)Subpart A – General ProvisionsSubpart B – Construction and Maintenance of Facilities and EquipmentSubpart C – Product Quality ControlSubpart D – Packaging and LabelingSubpart E – Records and ReportsSubpart F – Facilities and EquipmentSubpart G – Product Quality AssuranceSubpart H – LabelingSubpart I – RecordsPart 226Current good manufacturing practice for type A medicated articles (animal)Subpart A – General ProvisionsSubpart B – Construction and Maintenance of Facilities and EquipmentSubpart C – Product Quality ControlSubpart D – Packaging and LabelingSubpart E – Records and ReportsPart 250Special requirements for specific human drugsPart 290Controlled drugsPart 291Drugs used for treatment of narcotic addictsPart 299Drugs; official names and established namesSubchapter D - Drugs for Human Use (Part 300)Part 312Investigational new drug application (IND)Subchapter E - Animal Drugs, Feeds and Related Products (Part 500)Subchapter F - Biological Products (Part 600)Part 600Biological products: General (human and animal)Subpart A – General ProvisionsSubpart B – Establishment StandardsSubpart C – Establishment InspectionSubpart D – Reporting of Adverse ExperiencesPart 601LicensingPart 606Current good manufacturing practice for blood and blood componentsPart 607Establishment registration and product listing for manufacturers of human blood and blood productsPart 610General biological products standards (human and animal)Subpart A – Release RequirementsSubpart B – General ProvisionsSubpart C – Standard Preparations and Limits of PotencySubpart D – MycoplasmaSubpart E – Hepatitis RequirementsSubpart F – Dating Period LimitationsSubpart G – Labeling StandardsPart 640Additional standards for human blood and blood productsPart 660Additional standards for diagnostic substances for laboratory testsPart 680Additional standards for miscellaneous products (human and animal)Section 680.1 – Allergenic Products.Section 680.2 – Manufacture of Allergenic Products.Section 680.3 – Tests.NOTE: Text in italics indicates the substantive current good manufacturing practices as contained in Appendix 4 of the Pharmaceutical GMP Annex, U.S. Food and Drug Administration. (also see: GMP Regulatory System – I.E.3)Subchapter G - Cosmetics (Part 700)Subchapter H - Medical Devices (Part 800)Subchapter I - Mammography Quality Standards (Part 900)Subchapter J - Radiological Health (Part 1000)Subchapter K - ReservedSubchapter L - Regulations Under Certain Other Acts Administered by the FDA (Part 12000)Chapter II – Drug Enforcement Administration (DEA), Department of Justice (Parts 1300 – 1399)Chapter III – Office of National Drug Control Policy (Parts 1400 – 1499)

(IEEE) A meeting at which software code is presented to project personnel, managers, users, customers, or other interested parties for comment or approval.

(Myers/NBS) A manual testing (error detection) technique where program (source code) logic (structure) is traced manually (mentally) by a group with a small set of test cases, while the state of program variables is manually monitored, to analyze the programmer's logic and assumptions.

Data are separated from personal identifiers through use of a code. As long as a link exists, data are considered indirectly identifiable and not anonymous or anonymized. Coded data are not covered by the HIPAA Privacy Rule, but are protected under the Common Rule.

The transforming of logic and data from design specifications (design descriptions) into a programming language.

(IEEE) In software engineering, the process of expressing a computer program in a programming language.