Laboratory and LIMS Acronyms


21 CFR Part 11 US Federal Food and Drug Administration regulation 21CFR Part 11 governing electronic records and electronic signatures

Acceptance Criteria

The documented criteria that should be met to successfully complete a test phase or to meet delivery requirements.
Analyser Interface The mechanism by which an instrument is interfaced to a LIMS system. The data is collected through this interface and can then be imported into the LIMS.
Audit Trail An audit trail is a record of all changes that have been made to the information held about an entity over time, thus documenting the steps which lead to the current information record. This includes the creation and deletion of the entity, and any changes made to related attributes.
Backup Taking copies of data files or software at a known date/time, when the data is not volatile, so that it can be used as part of a contingency plan in case of the non-availability of the normal environment (whether as a result of hardware or ancillary system failure, or other disaster.)
Contingency Planning / Disaster Recovery Ensuring that provisions are made for the recovery of data files or software, or for the use of alternative computer equipment after a system failure or disaster.
Certified Copy A certified copy is a copy of original information that has been verified, as indicated by a dated signature, as an exact copy having all of the same attributes and information as the original.
Computerised System A group of hardware components and associated software designed and assembled to perform a specific function or group of functions.
Data Export Data Export is to transfer data within or among clinical study sites, contract research organisations, data management centres, sponsors etc
Direct Entry Direct entry is recording data where an electronic record is the original means of capturing the data. Examples are the keying by an individual of original observations into a system, or automatic recording by the system of the output of a balance that measures subject’s body weight.
Electronic Signature The entry in the form of magnetic impulses or computer data compilation of any symbol or series of symbols, executed, adapted or authorised by a person to be equivalent to the person’s handwritten signature.
GLP / GMP Good Laboratory Practice / Good Manufacturing Practice
Hardware The physical components of a computerised system, including the computer unit itself and its peripheral components.
IQ Installation Qualification
LIMS Laboratory Information Management System see HIS (Hospital Information System)
OECD Organization for Economic Co-operation and Development
OQ Operational Qualification
Original data Original data are those values that represent the first recording of study data.
Registration The process of booking / registering a sample
Sample A physical sample which needs to be processed
Sample Preparation Processing of a sample after it has been received by the Lab, to make It ready for analysis
Security The protection of computer hardware and software from accidental or malicious access, use, modification, destruction or disclosure. Security also pertains to personnel, data, communications and the physical and logical protection of computer installations.
Software (Application) A programme acquired for or developed, adapted or tailored to the test facility requirements for the purpose of controlling processes, data collection, data manipulation, data reporting and/or archiving
Software (Operating  System) A programme or collection of programmes, routines and sub-routines that controls the operation of a computer. An operating system may provide services such as resource allocation, scheduling, input/output control, and data management.
Source Code An original computer programme expressed in human-readable form (programming language) which must be translated into machine- readable form before it can be executed by the computer.
TCP/IP Transmission Control Protocol/Internet Protocol. A communications protocols used to connect to different computers over a network. The de facto standard for transmitting data over the Internet.
Technical Standards Standards supported by national or international standard setting bodies (ISO, IEEE, ANSI, etc.)
URS User Requirements Specification. This is a document that describes what the intended system should do and how it should perform
Validation of a Computerised System: The demonstration that a computerised system is suitable for its intended purpose