Acceptance Criteria (ANSI/IEEE):
The criteria a software product must meet to successfully complete a test phase or to achieve delivery requirements.
Levels or ranges distinct from product specifications which, when deviated from, signal a drift from normal operating conditions and which require actions. Alert or Warning Levels: Levels or ranges which, when deviated from, signal a potential drift from normal operating conditions but which do not necessarily require action. New to the Pharmaceutical glossary.
Application Software (PMA CSVC):
A program adapted or tailored to the specific user requirements for the purpose of data collection, data manipulation, data archiving or process control.
Audit (ANSI N45.2.10-1973):
An activity to determine through investigation the adequacy of, and adherence to, established procedures, instructions, specifications, codes, and standards or other applicable contractual and licensing requirements, and the effectiveness of implementation.
The organisation to be audited. Auditor: A person qualified to perform quality audits.
Term used to cover a broad range of systems, including automated manufacturing equipment, control systems, automated laboratory systems, manufacturing execution systems and computers running laboratory or manufacturing database systems. The automated system consists of the hardware, software and network components, together with the controlled functions and associated documentation. Automated systems are sometimes referred to as computerized systems; in this Guide the two terms are synonymous.
Bespoke: A system produced for a customer, specifically to order, to meet a defined set of user requirements. New to the Pharmaceutical Pharmaceutical glossary.
A manifestation of an error in software (a fault).
Demonstration that a particular measuring device produces results within specified limits by comparison with those produced by a reference standard device over an appropriate range of measurements. This process results in corrections that may be applied to optimiZe accuracy.
The purpose of the Corrective And Preventive Action subsystem is to collect information, analyse information, identify and investigate quality and product issues, and take appropriate and effective corrective and/or action to prevent their recurrence.
Certification (b. ANSI/ASQC A3 1978):
• Documented testimony by qualified authorities that a system qualification, calibration, validation or revalidation has been performed appropriately and that the results are acceptable.
• The procedure and action by a duly authorised body of determining, verifying, and attesting in writing to the qualifications of personnel, processes, procedures, or items in accordance with applicable requirements.
cGMP (Code of Federal Regulations):
Abbreviation for current Good Manufacturing Practice.
Change Control (PMA CSVC):
A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state. New to Pharmaceutical Glossary.
A document specifying the details of an authorised change request. New to Pharmaceutical Glossary.
A plan defining the details of the authorised change request, defining actions, responsibilities and procedures.
A program used to translate a higher order language into its re-locatable or absolute machine code equivalent.
Means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
Computerized System (PMA CSVC):
A process or operation integrated with a computer system.
Computer Hardware (PMA CSVC):
Any physical element used in a computer system.
Computer System (PMA CSVC):
A group of hardware components and associated software designed and assembled to perform a specific function or group of functions. Added to Pharmaceutical Glossary.
Configuration: The documented physical and functional characteristics of a particular item or system. A change converts one configuration into a new one. New to Pharmaceutical Glossary.
Configuration Management (ANSI/IEEE):
The process of identifying and defining the configuration items in a system, controlling the release and change of these items throughout the system life cycle, recording and reporting the status of configuration items and change requests, and verifying the completeness and correctness of configuration items.
Documented evidence to show that those constructional aspects of a facility which can affect product quality have been constructed in accordance with the approved specification. new to the Pharmaceutical glossary.
Those operating variables that can be assigned values that are used as control levels.
Control Parameter Range:
Range of values for a given control parameter that lies between its two outer limits or control levels.
Critical Process Parameter:
A process-related variable which, when out-of-control, can potentially cause an adverse effect on fitness-for-use of an end product. Added to Pharmaceutical Glossary
The pharmaceutical customer or user organisation contracting a supplier to provide a product. In the context of this document it is synonymous with User.
Collection of data fundamental to a system.
Distributed Control System.
Dead Source Code (K.G. Chapman):
1. Superseded code from earlier versions. Avoided by using quality software development standards; New to the Pharmaceutical glossary.
2. Residue from system modification. Avoided by effective configuration change controls;
3. Rarely used code that appears dead such as: - modules in some large configurable programs; - certain diagnostic programs that are intended to be inactive until needed. Removal of code in category 3 leads to serious potential future problems. "Idle code" can be "parked" in libraries until needed.
The process of locating, analysing, and correcting suspected faults.
Design History File (DHF):
Means a compilation of records which describes the design history of a finished device.
Design History Record (DHR):
Means a compilation of records containing the production history of the finished device.
Device Master Record (DMR):
Means a compilation of records containing the procedures and specifications for a finished device.
Design Specification (a. GAMP Forum, b. IEEE):
a. This is a complete definition of the equipment or system in sufficient detail to enable it to be built. This links to Installation Qualification which checks that the correct equipment or system is supplied, to the required standards and that it is installed correctly. Added to Pharmaceutical Glossary.
b. The specification that documents the design of a system or system component to satisfy specified requirements.
Formal and systematic verification that the requirements defined during specification are completely covered by the succeeding specification or implementation. New to Pharmaceutical Glossary.
Documentation (ANSI N45.2.10-1973):
Any written or pictorial information describing, defining, specifying, reporting or certifying activities, requirements, procedures, or results.
A control parameter value that, if exceeded, means adverse effect on state of control and/or fitness for use of the product.
An input command requiring restricted entry made under a level of higher authorisation, which signifies an act of approval.
Electronic Identification (eID):
An electronic measure that can be substituted for a hand-written signature or initials for the purpose of signifying approval, authorisation or verification of specific data entries. Added to Pharmaceutical Glossary.
An input command that enables a designated user, or the computerised system itself, to electronically signify verification or endorsement of a specific step, transaction or data entry. Source of the electronic verification may be made visible or invisible to users of the data. Added to Pharmaceutical Glossary.
A system, usually microprocessor or PLC based, whose sole purpose is to control a particular piece of automated equipment. This is contrasted with a standalone computer system. Added to the Pharmaceutical glossary.
Ancient legal term also applied to the deposit of source code documentation by the software developer with an independent third party, called the Escrow Agent. The agent holds the source code documentation upon the terms and conditions set out in the Escrow agreement. These terms allow him to release it to specified users of the software in certain circumstances. These circumstances are usually the bankruptcy, or liquidation of the software developer. More recently it is used to allow code documentation used in regulated industries to be made available to reviewing regulators, without allowing general access that would carry commercial risks.
Executive Program (ANSI/IEEE/ASO):
A computer program, usually part of the operating system, that controls the execution of other computer programs and regulates the flow of work in a data processing system.
External Quality Audit:
A systematic and independent examination to determine whether quality activities and related results comply to a documented Quality System and whether this documented Quality System is implemented effectively and is suitable to achieve the contractual requirements placed by the customer.
The Factory Acceptance Test (FAT) is a major project milestone in a any project where the equipment and/or system vendor demonstrates that their designed and manufactured system meets the requirements specified in the User Requirements Specification Document (URS).
Flow Chart (ANSI/IEEE):
A graphical representation of the definition, analysis or solution of a problem in which symbols are used to represent operations, data, flow, and equipment.
This is software which is under configuration control and may not be altered without change control. Added to Pharmaceutical Glossary.
Functional Requirement (ANSI/IEEE):
A requirement that specifies a function that a system or system component must be capable of performing.
Functional Testing (Bluhm, Myers, Hetzel):
Also known as "BLACK BOX" testing, since source code is not needed. Involves inputting normal and abnormal test cases; then, evaluating outputs against those expected. Can apply to computer software or to a total system.
A term often used by regulators to describe a procedure they expect to see in place. This is often given as the minimum effort required to establish compliance with a regulation. It also often describs what the regulators consider 'best practice'.
Hardware Acceptance Test Specification:
(see Installation Qualification below). Documented verification that all key aspects of hardware installation adhere to appropriate codes and approved design intentions and that the recommendations of the manufacturer have been suitably considered.
Hardware Design Specification (APV):
Description of the hardware on which the software resides and how it is to be connected to any system or equipment.
High Level Review of Software: Purposes: determine if programs meet design specs as described by such documents as modular flow diagrams, HIPO charts, pseudo code and operating manuals. Characteristics: involves comparing design specs and acceptance criteria with cognitive mechanisms which depict the program in terms more easily understood by automation practitioners and non-computer scientists. Uses: quality acceptance review by QA software auditing, for example to complement "walk-through", for inspections, and for troubleshooting problems.
Documented verification that all key aspects of [software and] hardware installation adhere to appropriate codes and approved design intentions and that the recommendations of the manufacturer have been suitably considered.
Integration Testing (IEEE):
An orderly progression of testing in which software elements, hardware elements, or both are combined and tested until the entire system has been integrated.
A shared boundary. To interact or communicate with another system component.
Life Cycle Concept (PMA CSVC):
An approach to computer system development that begins with identification of the user's requirements, continues through design, integration, qualification, user validation, control and maintenance, and ends only when commercial use of the system is discontinued. Added to Pharmaceutical Glossary.
Laboratory Information Management System.
Checking the installed combination of elements characterizing each type of input/output loop.
Lot or batch:
Means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.
Low Level Review of Software:
• detect possible coding errors.
• determine adherence to design specs.
• determine adherence to standards.
• implement path analyses characteristics:
• requires highly trained experts who are familiar with software/hardware systems on which program is based.
• to conduct low-level line-by-line source code inspection requires a team of experts working no more that two 2 hour sessions/day; this means about 100-150 lines of code per man-day (1.5 million lines = 40 man years) Use: chiefly during software development.
Machine Code (ANSI/IEEE):
A representation of instructions and data that is directly executable by a computer (machine language).
Major Change (PMA CSVC):
A change to a validated system that, in the opinion of change-control reviewers, necessitates a revalidation of the system.
Minor Change (PMA CSVC):
A change to a validated system that, in the opinion of change-control reviewers, does not necessitate a revalidation of the system.
Modularity (Software) (ANSI/IEEE):
The extent to which software is composed of discrete components such that a change to one component has minimal impact on other components.
Material Requirements Planning.
Manufacturing Resource Planning.
Network (a. ANSI/IEEE, b. GAMP Forum)
a. An interconnected or interrelated group of nodes.
b. An interconnected communications facility.
c. A Local Area network (LAN) is a high bandwidth (allowing a high data transfer rate) computer network operating over a small area such as an office or group of offices.
All outside influences that interface with the system.
Means the nonfulfillment of a specified requirement.
Operating System (a. PMA CSVC, b. ANSI/IEEE)
a. A set of programs provided with a computer that function as the interface between the hardware and the application programs.
b. Software that controls the execution of programs. An operating system may provide services, such as resource allocation, scheduling, input/output control, and data management.
Documented verification that the equipment-related system or subsystem performs as intended throughout representative or anticipated operating ranges.
Performance Qualification [PQ]:
Documented verification that the process and/or the total process-related system performs as intended throughout all anticipated operating ranges. Added to Pharmaceutical Glossary.
Planned Change (PMA CSVC):
An intentional change to a validated system for which the implementation and evaluation program is predetermined.
Programmable Logic Controller.
Policy (PMA CSVC):
A directive usually specifying what is to be accomplished.
Procedure (PMA CSVC):
A directive usually specifying how certain activities are to be accomplished.
Process System (PMA CSVC):
The combination of process equipment, support systems (such as utilities), and procedures used to execute a process. Added to Pharmaceutical Glossary.
Any piece part or system supplied by the supplier to the customer as the result of an agreed contract between the two parties.
The validation of new or recently installed systems following a Life Cycle Concept (see PMA definition).
Proven Acceptable Range (PAR):
All values of a given control parameter that fall between proven high and low worst-case conditions.
Pseudo code (ANSI/IEEE):
A combination of programming language and a natural language used for computer program design.
A prospective experimental plan that when executed is intended to produce documented evidence that a system or subsystem has been properly qualified.
Quality Assurance [QA] (a. ANSI/IEEE, b. Dr J M Juran):
a. A planned and systematic pattern of all actions necessary to provide adequate confidence that the item or product conforms to established technical requirements. Added to Pharmaceutical Glossary.
b. The activity of providing, to all concerned, the evidence needed to establish confidence that the quality function is being performed adequately. Added to Pharmaceutical Glossary.
Quality Control [QC] (Dr J M Juran):
The regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference.
The entire collection of activities from which fitness for use is achieved, no matter where these activities are performed. Added to Pharmaceutical Glossary.
A plan created by the supplier to define actions, deliverables, responsibilities and procedures to satisfy the customer quality and validation requirements.
The organisational structure, responsibilities, procedures, processes and resources for implementing quality management.
Checking each input output loop across its intended operating range.
Any work-sheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities and which are necessary for the reconstruction and evaluation of a work project, process or study report, etc. Raw data may be hard/paper copy or electronic but must be known and defined in system procedures. Added to Pharmaceutical Glossary.
A regulation is a requirement that the regulatory authorities consider essential. They therefore have issued a document carrying a regulatory compliance identity which defines the requirement and usually the importance that they attache to compliance with the requirement.
Re-qualification (PMA CSVC):
Repetition of the qualification or a portion thereof.
• A condition or capability needed by a user to solve a problem or achieve an objective
• A condition or capability that must be met or possessed by a system or system component to satisfy a contract, standard, specification, or other formally imposed document. The set of all requirements forms the basis for subsequent development of the system or system component.
Commodities and human time used in the production of goods and services, including man hours.
Meaning that all commodities, man hours and equipment have been planned for, budgeted for, and will be available at the correct time for the execution of a task or production of an item.
Retrospective Validation (PMA CSVC):
Establishing documented evidence that a system does what it purports to do based on an analysis of historical information.
Repetition of the validation process or a specific portion of it.
Supervisory Control And Data Acquisition. Added to Pharmaceutical Glossary.
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 protection of computer installations.
This word is used in the example procedures throughout the appendices so that they may be used without alteration.
The stated requirement is strongly recommended.
The representation of selected characteristics of the behaviour of one physical or abstract system by another system. In a digital computer system, simulation is done by software; for example,
(a) the representation of physical phenomena by means of operations performed by a computer system,
(b) the representation of operations of a computer system by those of another computer system. Added toPharmaceutical Glossary.
The Site Acceptance Test (SAT) is where the vendor demonstrates and verifies that the equipment and/or system as delivered to place of use, meets the requirements specified in the User Requirements Specification Document (URS).
Software (PMA CSVC):
A collection of programs, routines, and subroutines that controls the operation of a computer or a computerised system.
Software Life Cycle (ANSI/IEEE):
The period of time that starts when a software product is conceived and ends when the product is no longer available for use. The software life cycle typically includes a requirements phase, test phase, installation and checkout phase, and operation and maintenance phase. Added to Pharmaceutical Glossary.
Source Code (PMA CSVC):
An original computer program expressed in human-readable form (programming language), which must be translated into machine-readable form before it can be executed by the computer.
A documented evaluation of the detailed specification, carried out for the purpose of confirming compliance with the User Requirement and Functional Specifications and providing the detailed design documentation required for subsequent stages of validation (eg Installation and Operational Qualification) and ongoing operation of the facility or system in compliance with regulatory requirements related to product quality. Added to Pharmaceutical Glossary.
A self-contained computer system which provides data processing, monitoring or control functions but which is not embedded within automated equipment. This is contrasted with an embedded system, the sole purpose of which is to control a particular piece of automated equipment.
Standards are set by institutions and government departments. They establish qualities and scopes for certain tasks / processes / procedures so as the layman and or the qualified person knows what the item they are ordering / purchasing consists of and is capable of. It simplifies procurement, because you can list standards that you require to be embodied in, or must have been used in, the production of any item you are intending to purchase.
Structural Testing (Bluhm, Meyers, Hetzel):
Examining the internal structure of the source code. includes low-level and high-level code review, path analysis, auditing of programming procedures, and standards actually used, inspection for extraneous "dead code", boundary analysis and other techniques. Requires specific computer science and programming expertise.
Any organisation or individual used by a supplier to provide material or services which are embodied in the product to be supplied.
A self contained program unit which forms part of a program. Sub-programs are sometimes referred to as procedures, subroutines or functions.
Any organisation or individual contracted directly by the customer to supply a product. Added to Pharmaceutical Glossary.
An assembly of units consisting of one or more micro processors, associated hardware and all layers of system and application system.
System Acceptance Test Specification:
Documented verification that the automated system or subsystem performs as defined in the Functional Specification throughout representative or anticipated operating ranges. Added to Pharmaceutical Glossary.
System Software (ANSI/IEEE):
Software designed for a specific computer system or family of computer systems to facilitate the operation and maintenance of the computer system and associated programs, for example, operating systems, compilers, utilities.
System Specifications (PMA CSVC):
Describes how the system will meet the functional requirements.
A person performing the test. Added to Pharmaceutical Glossary.
The process of exercising or evaluating a system or system component by manual or automated means to verify that it satisfies specified requirements or to identify differences between expected and actual results. Added to Pharmaceutical Glossary.
Unplanned (Emergency) Change (PMA CSVC):
An unanticipated necessary change to a validated system requiring rapid implementation. Added to Pharmaceutical Glossary.
User Requirements Specification. Usually written up in two or even three stages.
1. Lists the end users needs, what they want the item for and what they expect it to do.
2. This breaks down the end users needs and expectation into individual functions that are essential to attaining these aims.
3. This lists, where software is used, the individual or groups, of lines of code that are used to attain each function. In this format of URS, traceability from the end users expectations to the software code is maintained. Modifications and testing can be carried out with an assurance that the Full Life Cycle requirements are complied with.
The pharmaceutical customer or user organisation contracting a supplier to provide a product. In the context of this document it is, therefore, not intended to apply only to individuals who use the system, and is synonymous with Customer.
Utility Software (ANSI/IEEE):
Computer programs or routines designed to perform some general support function required by other application software, by the operating system, or by system users.
"Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes". - FDA Guidelines on General Principles of Process Validation, May 1987.
A plan created by the customer to define validation activities, responsibilities and procedures. Added to Pharmaceutical Glossary.
Validation Protocol (PMA CSVC):
A list of inspections and or tests written specifically for verifying that the item under qualification, has been Designed (DQ), Installed (IQ), Operates (OQ) and Performs (PQ) in accordance with the end users requirements (URS). That it conforms to the relevant Health and Safety requirements, the rules and guidelines as detailed in cGMP and will be continually consistent in use.
A person observing the test and results, on behalf of the owner.
Worst case (FDA 1987):
A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, which pose the greatest chance of process or product failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure.