PDA Glossary

Agreeing in kind, amount; unchanged in character or condition. (TR38)

This indicates the number of units of product from each lot or batch which are to be inspected (sample size or series of sample sizes) and the criteria for determining the acceptability of the lot or batch (acceptance and rejection numbers). (TR43)

The number of units of product from each lot or batch that need to be inspected (sample size or series of sample sizes) and the criteria for determining the acceptability of the lot or batch (acceptance and rejection numbers). (TR 76)

The quality of product for which the percent of lots expected to be accepted (Pa) is 95.0. These values are found in Tables X-A-1 to X-R-1 in ANSI/ASQ Z1.4.(TR76)

Reduction of microbial contaminants to safe levels as judged by public health requirements for the specific country. (TR13)

A significant reduction in bioburden, achieved in chromatography by the use of bactericidal agents, such as sodium hydroxide (NaOH), hydrochloric acid (HCl), ethanol (EtOH), and isopropanol (IPA). (TR14)

The process of reducing microbial levels by treatment at less than defined sterilizing conditions. Typically water at 80 °C or a chemical treatment is used to perform sanitization of process components. (TR45)

A process that reduces the number of viable microorganisms to a defined level. (TR61) (TR69)

To make physically clean and to remove and destroy, to the maximum degree that is practical, agents injurious to health. (TR70)

A compound that will reduce the number of vegetative microorganisms to a safe level as determined by public health requirements. Normally a reduction of 10³ in vegetative microorganisms is obtained. (TR70)

Steam that is at a temperature and pressure that corresponds to the vaporization curve of water. It is in a state of equilibrium between being a liquid and a gas, with no entrained liquid water. [Synonym: Dry Saturated Steam] (TR01) (TR48) (TR61)

A sterilization process, typically used for porous/hard goods loads, where the sterilizing medium is saturated steam. (TR01)

Studies used to assess sizing for the appropriate performance of filter media at increased process volumes. (TR45)

The process of decreasing the column volume. (TR38)

A small-scale process step that has been demonstrated to be representative of a production-scale operation. (TR14)

The process of increasing the column volume (TR38)

Optical inhomogeneities in transparent material not necessarily visible to the human eye. In the context of this technical report, Schlieren (from German Schliere, meaning “streak”) are due to localized variations in silicone oil thicknesses. (TR73)

Studies used to select a particular type and grade of filter media. (TR45)

Substance of established quality and purity that is qualified against, and used instead of, the primary reference standard; typically used as a reference standard for routine laboratory analysis. (TR57-2)

A component that is not nor will not be in direct contact with the drug product (e.g., vial seals, overwraps, container labels). The purpose of secondary packaging is to identify, protect, market, and communicate information about the product. Examples of secondary packaging include labels, cartons/folding boxes, and leaflets. (TR39)

Consists of machine-assisted handling and pre­sentation of filled containers to allow for human visual inspection. (TR79)

Term for the internal or external source or originator site of the technology to be transferred. (TR65)

Person(s) who direct and control a company or site at the highest levels with the authority and responsibility to mobilize resources within the company or site (TR54) (TR54-2)

Ability of a method to detect small changes in the quality attribute (e.g., changes in concentration or purity) being measured. (TR57-2)

Olfactory sensation, odor threshold and taste threshold or organohalogen. (TR55)

Affective and analytical are two major classifications of sensory tests. Affective tests determine consumer response to products, while analytical tests measure the perceived sensory attributes of products. Affective tests are usually commissioned by market researchers and include preference and hedonic (liking) tests to compare products. These tests support product launch decisions, and product positioning, including advertising. Analytical tests are used in the evaluation of product differences and similarities under controlled laboratory conditions to identify and quantify perceived sensory characteristics. Analytical tests include discrimination tests, grading tests, ratings by expert tasters, and descriptive methods such as the flavor profile. The descriptive methods have the greatest applicability to the development of palatable pharmaceuticals. The ASTM International Committee E-18 on Sensory Analysis of Products and Materials publishes a set of standard practices, guidelines and methods. (TR55)

Device using constructional and dynamic means to create assured levels of separation between the inside and outside of a defined volume. [Synonym: Separative Device] (TR51)

Filtration through two or more filters of the same or decreasing pore size, one after the other. (TR26)

Microorganisms that are attached to animate or inanimate surfaces, as opposed to planktonic organisms. (TR69)

The target for an operational parameter. The range around the set point is commonly stated in the manufacturing procedures or batch records. (TR42)(TR60-3)

The specific temperature programmed by the user into the TCU that establishes the target temperature in the CES (cold room, truck/trailer, intermodal container, or ULD). (TR64)

The value to which an operational parameter is set. The process should operate in a range around a given a set-point that is stated in the manufacturing procedures or batch records. (TR14)

A measure of the possible consequences of a hazard. (TR44) (TR54) (TR54-2) (TR54-3)(TR54-4) (TR54-5)

Relative motion between adjacent layers of a moving liquid. (TR69)

The velocity gradient in a flowing fluid. This value is proportional to the average linear velocity and is inversely proportional to the channel height or diameter when the recirculation is in the laminar flow regime (most TFF applications). (TR15)

The time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label. (TR63)

Scheduled periods of work or production, usually less than 12 hours in length, staffed by alternating groups of workers. (TR22) (TR62)

An individual or company who tenders products for transportation. (TR39)

The person or organization responsible for arranging transportation of goods with carriers and/or freight forwarders. (TR58)

The transit of any material by land, sea, or air from one site to another. This may include intraplant movements. (TR39)

A standardized reusable metal box used for safe, efficient and secure storage and movement of materials and products within a global containerized intermodal freight transport system. Intermodal implies that the container can be moved from one mode of transport to another without unloading and reloading. They are the main type of equipment used in intermodal transport, particularly when one of the modes of transportation is by ship. They can also be referred to as ISO containers because the dimensions have been defined by ISO. Other types of transportation containers can include truck trailers. (TR55)

Documents that have been written for a particular shipment; for example, CMR (Convention Relative au Contract de Transport International de Marchandises par la Route), BOL (Bill of Lading) and/or AWB (airway bill). (TR58)

An established route of transportation between a specific point of origin to a specific destination. More defined routes will consistently use the same combination and types of transportation vehicles and transfer procedures, but this may not be observed through all shipping lanes throughout the last mile. (TR46)

Lane described by origin, transportation node(s) and destination in combination with the used transport mode(s) (truck, aircraft, etc.). (TR58)

Size-exclusion filtration occurs when a particle is too large to pass through the filter medium and is retained on the surface or within the depth of the filter. (TR45)

The ratio of the filtrate concentration of component i (Ci,f) to the bulk or feed concentration of component i (Ci,b) as in the following equation: S = Ci,f/Ci,b Where S = 1 for a freely passing solute, typically a low molecular weight solute S = 0 for a solute that is fully retained by the membrane [Synonym: transmission; product transmission] (TR15)

A means to quantify the ability to discern between signal and noise. According to the theory, there are a number of determiners of how a detecting system will detect a signal, and where its threshold levels will be. The theory can explain how changing the threshold will affect the ability to discern, often exposing how adapted the system is to the task, purpose or goal at which it is aimed. (TR55)

A significant body of information on the stability of the drug product is likely to exist after 5 years of commercial experience for new molecular entities, or 3 years of commercial experience for new dosage forms (TR38)

Having a general likeness. (TR38)

The quality of product for which the percent of lots expected to be accepted (Pa) is 95.0. These values are found in Tables X-A-1 to X-R-1 in ANSI/ASQ Z1.4-2003. (TR43)

An individual part designed to perform a particular function when assembled into a single-use system. (TR66)

An engineered process equipment solution, most commonly assembled from components made using polymeric materials, which together create a system or unit operation designed for one time or campaign use. (TR66)

The SAT is a series of tests that are performed as part of commissioning after the unit has been installed in the final location. (TR48)

A technique which separates particles based on diameter. (TR41)

Plastic sheets often made of polyethylene and sometimes used in distribution/transportation warehouse and shipping systems to separate pallet loads of product. Slip sheets may be important due to the ability of polyethylene to concentrate TBA in proximity to product. (TR55)

A homogenous distribution of resin particles in a liquid. (TR14)

To mix resin particles in a liquid to achieve a homogenous liquid suspension. (TR14)

The chemical or microbiological materials left on process equipment after completion of process manufacturing, but before initiation of the cleaning process. (TR29)

To use sound energy to agitate particles; generally used to accomplish mixing or cleaning. (TR70)

In the context of this Technical Report, the technique is used for dispersing viruses by use of sound-wave energy. (TR47)

Virus that is closely related to the known or suspected virus (same genus or family), having similar physical and chemical properties as those of the observed or suspected virus. (TR41)

A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. (TR14)

A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. Drug product and drug substance specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities (TR38) (TR57)

A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. Drug product and drug substance specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities (TR69)

A list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance, drug product, or materials at other stages of its manufacture should conform to be considered acceptable for its intended use. “Conformance to specification” means that the drug substance and drug product, when tested according to the listed analytical procedures, will meet the acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. (TR56) (TR74)

A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use (17). (TR60-3)(TR88)

The ability of an analytical procedure to accurately measure or detect a target analyte in the presence of other components in the sample matrix. (TR50)

The ability to assess unequivocally the analyte in the presence of components that may be expected to be present. Typically these might include impurities, degradants, matrix, etc. Lack of specificity of an individual analytical procedure may be compensated by other supporting analytical procedure(s). (TR57)

The ability to detect a range of microorganisms, which demonstrate that the method is fit for its intended use. (TR33)

Microorganisms with limit tests for absence in 1 or 10 g of a drug product, as described in USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms and USP <1111> Microbiological Quality of Nonsterile Pharmaceutical Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. (TR67)

The addition of a small known amount of a known compound to a standard, sample, or placebo, typically for the purpose of confirming the performance of an analytical procedure or the calibration of an instrument. (TR57)

A bacterial dormant form that is highly resistant to adverse conditions. Fungal spores are not highly resistant; their susceptibilities are closer to vegetative microorganisms. (TR13)

The number of log reductions (10-fold changes) of spores from the initial population. For the overkill sterilization method, one targets a spore log reduction of 12 to achieve 1 x 10^-6 probability of a survivor when using a biological indicator having a population of 1 x 10⁶. (TR61)

A process that destroys or inactivates microbial spores. (TR51)

The destruction of inactivation of microbial spores using a vapor or gaseous agent. (TR51)

A compound that destroys all vegetative microorganisms and bacterial and fungal spores. (TR70)

The formation of a spore. (TR51)

The capacity of a drug substance or a drug product to remain within specifications established to ensure its identity, strength, quality, and purity throughout the retest period or expiration dating period, as appropriate. (TR39)

The chemical/biological fidelity of an analyte in a given solvent/matrix under specific conditions. (TR57)

A stability budget considers the results of long-term, accelerated, freeze-thaw, and temperature cycling studies to determine the amount of time out of storage that a drug substance may experience without any significant risk to its quality. Firms have used the idea of a stability budget to assign permissible time out of storage for packaging and labeling operations for refrigerated drug products for some time. This concept has been expanded in the present document to include storage and distribution as well. (TR53)

The physical, chemical, biological, and microbiological behavior of a drug substance or drug product as a function of time when stored under the defined environmental conditions of an approved protocol. (TR39)

A test procedure that is able to discern changes in an analyte due to degradation processes. It is capable of accurately measuring changes in the product that can occur under conditions of physical or chemical stress. (TR57)

Nonremovable, fixed needle attached to syringe body/cone with adhesive. (TR73)

Any individual, group or organization that can affect, be affected by or perceive itself to be affected by a risk. Decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are the patient, health-care professional, regulatory authority, and industry (ICH Q9). (TR54) (TR54-2)

Any individual, group, or organization that can affect, be affected by, or perceive itself to be af­fected by a risk. Decision makers might also be stakeholders. (TR54-5)

A pressure of 1 atmosphere (14.70 psi or 760 mm of mercury) to which measurements of quantities dependent on pressure are often referred. (TR45)

A condition in which the set of controls consistently provides assurance of continued process performance and product quality. (TR57)

Monitoring of the environment in the absence of normal operations. This includes having the equipment installed and operational when no personnel are present. Per the EU and ISO standards, this is synonymous with “at rest.” (TR13)

A fixed-data document such as a paper record or an electronic image.(TR80)

A "fixed" record such as paper or pdf. (TR80)

A static record format, such as a paper or pdf record, is one that is fixed and allows little or no interaction between the user and the record content (TR80)

Limits calculated from historical data that takes into account the distribution of the data (i.e., normal, log-normal, exponential, etc), the variability of the data, and the sample size of the data set. These can be two-sided or one-sided. The mean (average) plus and/or minus 3 standard deviations or a confidence interval for the mean are not statistically correct methods for setting these limits. The correct method is to calculate a statistical tolerance interval as described in Hahn and Meeker, 1991. (TR38)

A sterilization process in which the heating medium used to heat the load is in a mixture of air and steam that is typically used for liquid loads. This addition of air results in an air overpressure condition. (TR01)

Pallets in which the wood has been heated to achieve a minimum core temperature of 56 °C (132.8 °F) for at least 30 min. Pallets treated via this method bear the initials HT (heat treated) near the International Plant Protection Convention (IPPC) logo. This is one of the methods required for international shipment. (TR55)

A sequence of defined steps and operating parameters (e.g., time, temperature, and pressure) performed in situ on equipment and/or systems to provide a given sterility assurance level (SAL) or defined sanitization level. (TR61)

A specifically sized hole (e.g., 1/32 or 1/

Supply Chain inch diameter) to allow condensate or steam to pass through. [Synonyms: flow orifice, steam bleed.] (TR60)

Sterilization by flowing saturated steam through a vented vessel or system. (TR45)

A self-actuating, automatic device that removes condensate and air from the system. (TR61)

Steam of undefined chemical or biological quality produced from a boiler, usually containing boiler additives, without further treatment. [Synonym: Factory Steam, House Steam, Industrial Steam] (TR48)

Process steam is similar to plant steam, except the steam is generated using a controlled feed water source to which no volatile additives (amines or hydrazines) have been introduced. Process steam may be appropriate for moist heat sterilization of liquid loads where the containers are filled and sealed prior to sterilization. (TR48)

Collected condensate that complies with the Compendial requirements for Water for Injecton (WFI). [Synonyms: clean steam, high quality steam] (TR01) (TR61) (TR48)

The process of applying clean pressurized steam to a stationary piece of equipment in order to sterilize it. (TR41)

Sealing bag made at least partly of steam-permeable material to wrap and seal containers for sterilization (e.g., tub-nest configurations). (TR73)

Absence of life; usually refers to absence of viable microorganisms. Note: In practice, no such absolute statement regarding the absence of microorganisms can be proven. (TR22) (TR62)

The absence of viable microorganisms. (TR44) (TR70)

The sterile boundary is the demarcation in a system between the portion of the system that requires sterile contact surfaces (e.g., sterile side of filters and downstream piping) and the rest of the system (e.g., upstream side of filters, condensate drain lines). (TR61)

The probability or likelihood that something is sterile. (TR44)

Probability that a batch of product is sterile. (TR28)

Probability of a single viable microorganism occurring on or in an item after sterilization. Note: The term SAL takes a quantitative value, generally 10^-6. When applying this quantitative value to assurance of sterility, an SAL of 10^-6 has a lower value but provides a greater assurance of sterility than an SAL of 10^-3. (TR3) (TR61)

Test performed to determine if viable microorganisms are present. (TR28) (TR62)

A process used to render a product free of viable organisms with a specified probability. (TR01) (TR30) (TR69)

A process by which something is rendered sterile (i.e., moist heat, dry heat, chemical, irradiation); normally validated at 10⁶ organism reduction. (TR70)

Validated process used to render product free from viable microorganisms (TR13) (TR26)

A sequence of defined operating parameters (e.g., time, temperature and pressure) and conditions required to render an item sterile. (TR01) (TR30) (TR48)

A sequence of defined operating parameters (e.g., time and temperature) required to render an item sterile. (TR3)

A process used to render a product free of viable organisms with a specified probability. (TR3)

Execution of a sterilization cycle. (TR01)

Documents that define sterilizer system attributes and how they should be met. (TR48)

A set of specifications and information related to the installation features including equipment, hardware and software) of the system that will ensure the realization of the user requirements. [Synonym: Detailed Design Specification (DDS] (TR48)

A description of functional attributes and operational characteristics of the system that will ensure fulfillment of the user requirements. [Synonym: Functional Requirement Specification, Functional Design Specification] (TR48)

A description of features and performance requirements of a system that will fulfill the needs of the end user. (TR48)

Physical evaluations (e.g., chamber integrity or air removal) conducted on a scheduled frequency to demonstrate ongoing control of the sterilizer system. (TR30)

A filter intended for terminal processing of sterile liquids that has been tested under worst-case actual processing conditions for the ability to retain a minimum challenge of 10⁷ cells of Brevundimonas diminuta per cm² of filter area. (TR41)

A filter that reproducibly removes all test microorganisms from the process stream, producing a sterile effluent. (TR75)

A filter that reproducibly removes test microorganisms from the process stream, producing a sterile filtrate. (TR26)

A surrogate for tangential flow filtration where shear is achieved by rapidly stirring the solution immediately adjacent to the membrane. Typically the stirring is accomplished by mechanical means, such as through the use of a stir bar or impeller. (TR15)

The retention of pharmaceutical products in a location such as a warehouse; the storing of pharmaceutical products up until their point of use. (TR53)

A solution typically selected to control bioburden during column storage. (TR14)

The temperature range listed on the medicinal product label specified for long term storage. (TR39)

A store is a temperature-controlled and / or temperature- monitored warehouse, chamber, or cabinet where pharmaceutical products are stored. (TR58)

A specific isolate of a species that is maintained in pure culture and is serotypically, genotypically, or chemotaxonomically characterized to differentiate it from other strains of the same species. The strain is representative of the species and provides a reference for the species based on its historic isolation, characterization, and deposition in recognized culture collections. (TR13)

Studies undertaken to elucidate the intrinsic stability of the drug substance and/or drug product; part of the development strategy and normally carried out under more severe conditions (e.g., high or low pH or oxidation levels, or shaking) than those used for accelerated testing. (TR57-2)

A continuous, longitudinal, solid or notched beam-component of a pallet used to support deck components, often identified by location as the outside or center stringer. (TR55)

A pallet that uses a frame of three or four parallel pieces of lumber (called stringers). The top decks are affixed to the stringers to create the pallet structure. (TR55)

An individual or company hired by the transport service provider to perform the actual shipment. The shipper and the sub-contractor do not necessarily have a contractual agreement. (TR39)

Individuals with specific technical expertise such as engineers, quality experts, automation special­ists, scientists, etc. (TR54-5)

Primary construction material of a surface to be cleaned or disinfected. (TR70)

Particulate matter sized below the visible particle 70% probability of detection threshold are con­sidered in the sub-visible range, typically <100- 150 μm. (TR79)

Physical interactions of components with equipment and environment. (TR73)

Acceptance criteria for a valid reported result(s). [Synonym: Assay quality control] (TR57)

Evaluative testing providing evidence to show that representative users in the expected use conditions can perform all essential and critical tasks required for safe and effective use of the device. (TR73)

Steam that is at a higher temperature than that indicated by the equilibration curve for the vaporization of water (at a given pressure).(TR01) (TR61)

Water in a liquid phase at a tempe- rature above 100°C requiring overpressure to maintain this state. (TR01)

A sterilization process in which the heating medium is superheated water that is continuously circulated with air overpressure. This process requires air overpressure to keep the water in a liquid state. [Synonyms: water cascade, water spray process, water immersion process, water submersion process, raining water process, steam-air-water process] (TR01)

A comparison with the primary objective of showing that the result from one method is superior to the method being compared. This is usually demonstrated by showing that the true difference is likely to lie between zero and the upper equivalence margin. (TR57)

Destructive reconstitution, dilution, transfer, clearing, solubilizing, filtration, screening, or sieving that allows a product to be visually exam­ined or evaluated microscopically to determine the presence, type, and size of foreign particulate contamination present within the product, con­tainer, or device. (TR79)

The entity with whom the agreement of the quality level is made and the transaction of purchase is made; the last link in the chain of manufacturers and distributors. The supplier may be the manufacturer.(TR76)

The process by which a drug product is shipped and distributed from the manufacturer to the end user. (TR39)

The tendency of the surface of a liquid to contract to the smallest area possible under defined conditions. It is expressed as dynes per centimeter. (TR26)

A soluble compound that reduces the surface tension of a liquid or reduces interfacial tension between two liquids (causing formation or micelles) or between a liquid and a solid. [Synonym:Wetting Agent] (TR45) (TR26)

A model process fluid used in a small-scale validation study. The fluid is intended to either match or resemble an actual process fluid as closely as is feasible. (TR41)

Graphical representation of the inactivation of a population of microorganisms with increasing exposure to a microbicidal agent under stated conditions. (TR01) (TR3) (TR51) (TR61)

Functionally equivalent substitution of an alternative SUS, for an existing SUS design providing a contingency or process improvement with equivalent process performance and product quality. The end user is responsible to evaluate and determine if appropriate quality requirements are met for their application. (TR66)

A suspension is a biphasic preparation consisting of solid particles dispersed throughout a liquid phase. Some suspensions are prepared and ready for use, and others are prepared as solid mixtures intended for reconstitution with an appropriate vehicle just before use. (TR79)

A clumping of fused neighboring cells (syncytia) caused by viral infection when viral fusion proteins are transported to the surface of the infected cells and cause the host cell membrane to fuse with neighboring cells. The number of syncytia is directly correlated to the number of infectious virus particles. (TR47)

The qualities required for delivery of the syringe contents at a given injection rate via a needle of a predetermined gauge and length that enables optimal injection conditions for the drug product, taking into account the product’s physical properties, flow rate, injection force, and needle gauge. (TR73)

D-value of a BI when measured in a specified gas generator/separative enclosure combination operating within a defined sporicidal vapor-phase decontamination cycle. (TR51)

Any test designed to detect leaks or other breaches in system integrity that might compromise operator safety or system sterility (or sanitary status). [Synonym: leak test.] (TR61)

A system integrity test that measures the mass flow needed to maintain a given pressure. (TR61)

A system integrity test in which the system is pressurized to a predetermined level with filter sterilized compressed air or other compressed gas, after which the system is isolated and the amount of pressure loss over time is measured. (TR61)

A system integrity test in which the system under test is evacuated to a predetermined setpoint and the system is isolated from the external environment. The decay in vacuum level over time is measured. (TR61)

Physical evaluations (e.g., chamber integrity or air removal) conducted on a scheduled frequency to demonstrate ongoing control of the sterilizer system. (TR01)

A “closed” system is sterilized-in-place or sterilized while closed prior to using a validated procedure, is pressure and/or vacuum tight to some pre-defined leak rate maintained through the length of the campaign, can be utilized for its intended purpose without breach to the integrity of the system, can be adapted for fluid transfers in and/or out while maintaining asepsis, is connectable to other closed systems while maintaining integrity of all closed systems (e.g., Rapid Transfer Port, steamed connection, etc.), is safe guarded from any loss of integrity by scheduled preventative maintenance and utilizes sterilizing filters for sterilization of process streams which are integrity tested and traceable to each product lot. (TR28)

A system which fails to meet one or more of the criteria which define a closed system. (TR28)

People, machines, and methods organized to accomplish a set of specific functions. Computer or related systems can refer to computer hardware, software, peripheral devices, networks, cloud infrastructure, operators, and associated documents(e.g., user manuals and standard operating procedures).(TR80)

A computerized system collectively controls the performance of one or more automated processes and/or functions. It includes computer hardware, software, peripheral devices, networks and documentation, e.g., manuals and standard operating procedures, as well as the personnel interfacing with the hardware and software, e.g., users and information technology support personnel.(TR80)