Glossary

The study of the application of computer and statistical techniques to the management of information. In genome projects, informatics includes the development of methods to search databases quickly, to analyze DNA sequence information, and to predict protein sequence and structure from DNA sequence data.

Also referred to as a Healthcare Professional Information sheet, this information from FDA is for doctors, pharmacists, nurses, and other health care professionals. It contains an “alert” (a summary of the new safety information), detailed information about the safety issue, factors to consider when making treatment decisions, information for health care professionals to discuss with patients about their roles in reducing the risks from the drug, and a summary of the facts or data that serve as the basis for the information in the sheet.

The practice of "hiding" the details of a function or structure, making them inaccessible to other parts of the program.

Strategy for aligning an organization’s IT infrastructure with the needs of the business, based on the changing value of the stored information. Through ILM, an organization achieves the most value from the information, at the lowest cost, at every point in its lifecycle.

An OAIS term. The content information and associated preservation description information, package information, and package description (metadata) which is needed to aid in the preservation of the content information. Information Packages can be of the Submission, Archival, and Dissemination.

A globally recognized methodology for IT service management. ITL processes include solutions for several important system management processes.

A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence. 45CFR46.116 and 45CFR46.117

The basic physical and organizational structures and facilities (e.g., buildings, roads, and power supplies) needed for the operation of a society or enterprise.

The hardware and software which must be present and functioning for an application program to run (perform) as intended, e.g., RDBM platforms, or server hardware platforms.

All of the computers with their associated hardware, software, and networks used to run the business other than the business applications and associated data.

(ATIL®) A connected series of actions with the intent of satisfying a purpose or achieving a goal in support of managing the infrastructure, e.g., the primary goal of the problem management process is to facilitate the timely collection, trending, and resolution of real and perceived problems.

A computerized part of the infrastructure controlled by personnel, or processes, e.g., printing service, email service, or file storage service.

A system designed or configured to support infrastructure processes – in contrast to supporting primary business processes.

The introduction of parenterals into a vein (intravenous).

An OAIS term. The services and functions that accept Submission Information Packages from Producers, prepares Archival Information Packages for storage and ensures that these and their supporting Descriptive Information (DI) become established within an archive.

Taking in and swallowing a substance through the mouth.

Breathing (aspirating) in a substance.

Transmitted through genes from parents to offspring.

Any substance or object that retards a chemical reaction; a major or modifier gene that interferes with a reaction or with the expression of another gene.

In water monitoring systems – Compared to Phase 1 of the ISPE C&Q GPG and based on risk assessment, this sampling phase can be satisfied by monitoring and testing all sample and use points in the distribution system and selected other points, daily for between 10 to 20 consecutive days depending upon the design of the system.(also see: Intermediary, Extended Sampling)

A preparation intended for parenteral administration and/or constituting or diluting a parenteral article prior to administration. The introduction of parenterals may be into the subcutaneous cellular tissue (subcutaneous or hypodermic), or the muscular tissue (Intramuscular).

The process of forming a material by forcing it from a heated cylinder, under pressure, through a sprue into a cavity of a confined mold.

International Nonproprietary Names (committee of WHO)

The cluster of cells inside the blastocyst. These cells give rise to the embryonic disk of the later embryo and, ultimately, the fetus.