Glossary

(ANSI) The capability of a functional unit to meet the requirements of a specified interface.

(EMEA – CHMP) Proof that no serious interaction between container closure material and content occurs that leads to altering efficacy and stability of the product or that presents a risk of toxicity.

The process of determining the ability of two or more systems to exchange information. In a situation where the developed software replaces an already working program, an investigation should be conducted to assess possible comparability problems between the new software and other programs or systems.

Official; purported to comply with USP, EP, or JP.

Official; purported to comply with USP, EP, or JP.

Purported to comply with USP and/or any other acknowledged body of work related to the quality, manufacture, or distribution of high purity water.

Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research.

Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.

National Competent Authority, Ministry of Health. A body with authority to act on behalf of the government of the respective country/state to perform licensing of medicines of that country.

(NIST) Translating a program expressed in a problem-oriented language or a procedure oriented language into object code.

The compiler takes the finished source code listing as input and outputs the machine code instructions that the computer must have to execute the program.

(IEEE) A computer program that translates programs expressed in a high-level language into their machine language equivalents.

Any oral or written communication from an end user of a medicinal product indicating that it had an adverse effect on a patient, did not function as specified, or appeared to be contaminated or defective in any way. The sponsor must promptly investigate all such complaints and document the investigation in a retrievable file. If the complaint is confirmed, corrective and preventive actions are required. Examples include FDA notification, product lot(s) withdrawal, product recall, and review of medical files of adverse events caused by the product. These requirements are found in US regulations in 21CFR 314, the CGP regulations.

The relationship of the nucleotide bases on two different strands of DNA or RNA. When the bases are paired properly (adenine with thymine [DNA] or uracil [RNA]; guanine with cytosine), the strands are complementary.

Two or more interdependent genes, such that (in the case of dominant complementarity) the dominant allele from either gene can only produce an effect on the phenotype of an organism if the dominant allele from the other gene is also present; or (in the case of recessive complementarity) only double homozygous recessive show the effect.

A type of integrated circuit widely used for processors and memories. It is a combination of transistors on a single chip connected to complementary digital circuits.

Nucleic acid base sequence that can form a doublestranded structure by matching base pairs with another sequence; the complementary sequence to GTAC is CATG.

The probability that less than 100 ppb of the protein-coding sequence of a gene is correctly predicted.

(NIST) The property that all necessary parts of the entity are included. Completeness of a product is often used to express the fact that all requirements have been met by the product.

Traditional computer architecture that operates with large sets of possible instructions. Most computers are in this category, including the IBM compatible microcomputers. As computing technology evolved, instruction sets expanded to include newer instructions which are complex in nature and require several to many execution cycles and, therefore, more time to complete. Computers which operate with system software based on these instruction sets have been referred to as complex instruction set computers.

(IEEE) The degree to which a system or component has a design or implementation that is difficult to understand and verify.

Pertaining to any of a set of structure based metrics that measure the attribute in definition (1).