Glossary

Dieses Glossar dient ausschließlich als Orientierungs- und Erklärungshilfe zu Fachbegriffen für unsere Kunden, die sich mit Servicethemen von Eppendorf beschäftigen um eine reibungslose Kommunikation zu ermöglichen.

Accreditation - Official certification issued by an independent third party stating that an organization/lab works according to recognized standards and meets defined specifications.

Accuracy - Measure used in statistics indicating the degree of closeness of an average value calculated from a large set of data to a recognized reference value. If the average value calculated from many measurements is close to the corresponding true value, the accuracy is high. However, nothing is revealed on the variance of the individual values.

Adjustment - Adjustment refers to the process of setting or comparing a tool based on a standard of known accuracy. Adjusting means changing a measuring tool in a permanent way. Tools are adjusted to avoid, to the largest possible extent, errors of measurement and errors in order not to exceed maximum permissible errors.

AMWHV - German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients. This ordinance represents the most important legal stipulations governing the handling of medicinal products and their active ingredients during production.

Analysis - Systematic examination separating the object to be examined in its constituent elements for examination and evaluation. The relations and interactions between the elements are considered in particular.

Audit - Systematic, independent and documented process performed by external bodies to determine to the extent to which defined requirements and specific criteria are fulfilled. Auditing is performed to assess whether an organization complies with defined values or targets.

Betriebsstunde - eine technische Zeiteinheit, die zur Messung der aktiven Betriebszeit wie auch zur Angabe der Lebensdauer verschiedener technischer Anlagen, Maschinen und Systeme verwendet wird. In Betriebsstunden wird beispielsweise die Dauer in Stunden angegeben, die eine technische Anlage zwischen zwei Wartungen in Betrieb bleiben kann, ohne mit schwerwiegenden Schäden wie dem Ausfall von Komponenten, Baugruppen oder Subsystemen aufgrund von Abnutzung oder Verschleiß rechnen zu müssen.

Calibration - Process of checking a device to determine if and to what extent the measurement values delivered by this device deviate from a previously specified reference value (the so-called "Normal"). The measured deviation is documented and calculated and a certificate is issued to complete the process. The settings of the device are not changed; this is part of the adjustment process.

Calibration range - The range between the lowest and the highest measured value. The calibration is invalid outside of the calibration range.

Certification - Process carried out to establish that a product, process or service meets the specified requirements.

Check - Assessment or inspection

Compliance - The fact that an existing situation complies with rules and standards.

Consistency - Degree of uniformity, standardization and consistency of documents, parts of a system, a component or a results.

DIN - Deutsches Institut für Normung (German Institute for Standardization). Independent institute defining and adopting internationally applicable rules and standards, e.g., for quality assurance.

DQ (Design Qualification) - Documented verification stating that the planned design of a product/equipment is suitable for the corresponding intended use and the working environment.

Evaluation - Systematic analysis or assessment of projects, processes and functional units (e.g., of devices)

FAT (Factory Acceptance Test) - Test of a product/ equipment usually performed at the manufacturer's premises usually involving the ordering party and the contractor.

FDA (Food and Drug Administration) - Federal agency of the United States for the supervision of food and drug safety. It issues laws and regulations such as GLP and GMP setting out specifications, e.g., for the manufacturing of drugs.

Function test - Final test ensuring that a product/equipment works as intended.

GAMP (Good Automated Manufacturing Practice) - Set of guidelines for the validation of computerized systems in the pharmaceutical industry.

GLP (Good Laboratory Practice) - GLP refers to an internationally applicable quality assurance system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

GMP (Good Manufacturing Practice) - The GMP describes guidelines valid throughout Europe required to specify a quality standard for the production of pharmaceutical products and, in addition, to specify their quality. In some countries outside the EU, local GMP legislation also describes requirements regarding medical and IVD products. GMP aims at protecting the health of consumers, i.e. to provide consumer and patient protection.

Guideline - The term as several meanings. There are technical guidelines issued by an organization and specifying a scope of action. Furthermore, legal guidelines are adopted by officially and legally authorized bodies. In both cases guidelines have a certain scope of application. Infringements can be subject to sanctions depending on the respective application, e.g., under labor law.

GxP - Abbreviation for good practice rules; the „G“ referring to „good“ and the „P“ referring to „practice“. The „x“ stands for the respective abbreviation of the specific area of application. It applies to pharmaceutical products from regulated environments in the fields of production, inspection, storage and distribution and, outside the EU, also to medical and IVD products.

H

Inspection - Inspection is the process of examining a device. The actual state of the device is determined and documented in writing. This includes checking the function of the overall equipment as well as of its parts, settings and values. The aim is to determine the proper and safe state of the device and whether it functions as intended.

Installation - Process of installing individual parts to build the assembled equipment, or loading of a computer program on the PC.

IQ (Installation Qualification) - Refers to the documented verification stating that facilities, systems and equipment, such as installed or modified, comply with the approved design and the manufacturer's recommendations.

ISO - International Organization for Standardization

ISO 9001 - ISO 9001 specifies minimum requirements for a quality management system to be implemented by companies in order to meet customer requirements as well as requirements with regard to the quality of products and services.

ISO/IEC 17025 - This standard is the international reference for testing and calibration laboratories with or without accreditation. ISO/IEC 17025 is composed of two main clauses: "Management Requirements" and "Technical Requirements". Management requirements are related to the operation and effectiveness of the quality management system within the laboratory and has similar requirements to ISO 9001. Technical requirements address the competence of the staff, testing methodology, devices and quality as well as the creation of test reports and calibration certificates.

Justierung - Justieren heißt, dass ein Messgerät eingestellt oder abgeglichen wird. Justieren erfordert einen Eingriff, der das Messgerät bleibend verändert. Durch die Justierung können Messabweichungen und Fehler möglichst geringgehalten werden, so dass Fehlergrenzen nicht überschritten werden.

Kalibrierung - Das Gerät wird dahingehend geprüft, ob und wie seine gemessenen Werte im Vergleich zu einem vorher festgelegten Bezugswert (sog. „Normal“) abweichen. Die gemessene Abweichung wird dokumentiert, berechnet und zum Schluss wird ein Zertifikat ausgestellt. Am Gerät selbst finden keine weiteren Einstellungen statt, das findet bei der Justierung statt.

Kalibrierbereich - Der Bereich vom kleinsten bis zum größten gemessenen Wert. Außerhalb des Kalibrierbereichs wird die Kalibrierung ungültig.

Konsistenz - Der Grad der Einheitlichkeit, Standardisierung und Widerspruchsfreiheit zwischen den Dokumenten, Teilen eines Systems, einer Komponente oder eines Ergebnisses.

Leistung - installierte oder maximal mögliche Leistung (Kennzeichen eines Gerätes oder einer Anlage; auch Nennleistung genannt)

Maintenance - Process of maintaining technical systems, assemblies, devices and equipment in good working order, or of restoring good working order after a failure.

Mean time between failures - Measure of reliability that indicates the expected mean time until a failure might occur.

Mean time to repair - Measure of reliability of a repairable device indicating the mean time between repairs.

Measurement - Actions performed to determine the value of a measured variable in relation to a standard unit.

Metrology - The science of measurement.

MQ (Maintenance Qualification) - Refers to all cleaning, maintenance and repair measures required for a device. These measures are documented in writing in a service log.

Norm - Ein von einer Normungsorganisation, wie z.B. dem Deutschen Institut für Normung (DIN) oder der International Organization for Standardization (ISO) geschaffener Standard /Norm. Eine Norm ist eine anerkannte Regel oder Richtschnur, die insbesondere in der Technik zu einer Vereinheitlichung von Eigenschaften, Produkten oder Prozessen führen sollen.

Official verification - Legally required inspection of measuring devices according to applicable verification standards. This includes measuring devices used, e.g., in the areas of consumer, environmental and occupational health protection as well as medical devices. Official verification is performed by the responsible verification authority.

The inspection is performed to determine whether a measuring device meets the verification standards, i.e. whether it complies with the applicable requirements. The stamp granted after the inspection states that the measuring device complied with these requirements at the time of the inspection and is expected to work "correctly" during the period following the verification provided that it is used in accordance with the operating manual.

Operating hour - Technical unit of time for measuring the active operating time and for indicating the life cycle of various technical equipment, machines and systems. For example, operating hours indicate in hours the period of time technical equipment may be operated between two services without risking any serious damage such as failure of components, assemblies or subsystems due to wear and tear.

OQ (Operational Qualification) - Documented verification that the facilities, devices and equipment, such as installed or modified, operate as intended throughout their specified operating range.

Outer inspection/visual inspection - Visual inspection is the process of visually inspecting a device/equipment for visual flaws and faults. Usually, devices that have already been put into operation are inspected visually. A distinction is made between direct visual inspection with or without auxiliary equipment and indirect visual inspection.

Performance - Installed or maximum possible performance (characteristics of a device or equipment; also referred to as nominal power)

PQ (Performance Qualification) - Documented verification that systems and equipment perform effectively and reproducibly based on the approved process method and product specification. Critical device parameters are checked using suitable test methods. These methods are documented in test specifications.

PT (Performance Test) - Physical test covering a broad range of technical and functional assessments that does not specify a material, product or system based on detailed material or component specifications but rather based on the final performance characteristics that can be measured. The method used can be both quantitative or qualitative.

Qualification - The qualification serves to check devices/equipment in order to ensure that they operate properly and deliver the expected results. It encompasses several process steps: design qualification (DQ), installation qualification (DQ), operational qualification (OQ) and performance qualification (PQ).

It is verified and documented that the checked devices/equipment were properly installed, function correctly and produce the expected results. The qualification is part of the validation, however, the individual steps of the qualification process do not correspond to process validation.

Reliability - Ability of a system or component to perform its required functions under specified conditions.

Repair - Process of restoring good working order of a unit, including renewal/exchange.

Re-qualification - Process of qualifying a device/equipment again that has already undergone qualification before.

Retrospective qualification - This qualification is performed after, e.g., expanding the functionality of a device/equipment.

Re-validation - Process of repeating the process validation to ensure that changes made to a process or equipment subject to specific change control management procedures do not affect the properties of the process or the results.

Rule - A rule is a regulation that should be abided by. In particular, rules are instructions on how to perform operations under certain conditions to achieve a specified result.

Robustness - The ability of a system to resist change without adapting its initial stable configuration. In most cases it is useful to indicate what the system is resistant to (e.g., resistant to changes of the ambient temperature).

Safety - The condition of being free from unjustifiable risks or of being considered free of dangers. With this definition, safety refers both to individuals and other beings but also to real inanimate objects or systems as well as abstract objects.

SAT - (Site Acceptance Test) Acceptance test/acceptance at the customer's premises, usually after the FAT (factory acceptance test) has taken place.

Service - Measures involving actions such at adjusting, cleaning, changing and overhauling equipment to retain it in the specified state, carried out in compliance with technical regulations or the manufacturer's instructions. Not to be confused with maintenance. Service is – like repair and inspection – part of maintenance.

Software update - Process of updating the software or other data.

Software upgrade - Process of changing a product to a higher configuration or version.

SOP (Standard operating procedure) - Written and approved work instructions on how to carry out routine operations, including checking and documenting results. It serves to help staff carry out their tasks properly.

Spare parts - Parts that are used to replace defective or worn parts of a complex product. Spare parts are required to replace, e.g., movable parts that are subject to wear and tear during normal operation, or to replace parts that get damaged or destroyed or become unusable due to improper handling or improper use.

Specification - A document describing comprehensively, precisely and in a verifiable way the requirements, the design, behavior or other properties of a product, system, component or service and, often, also the recommended procedures to determine if these requirements are met.

Standard procedure - A more or less uniform/standardized and recognized way of doing something. Standardization of products, procedures or methods, used especially in the technical field. Standard procedures are recommendatory in nature. (Notice: The English term "standard" corresponds to the German term "Norm".)

Test - A procedure intended to establish whether a thing, a person or a hypothesis delivers the expected results. In the technical field, tests are often understood as verifications, i.e. it is established whether the test object works as expected under preferably realistic conditions. A test is different from an experiment considering that before a test is carried out, there is an expected result that is to be supported or refuted. The outcome of an experiment is open or can only be assumed.

Test Report - Document that describes the performance of a test and records data obtained from the test carried out on a system or a system component.

Test specifications - Specified methods (usually documented in a normative document) for the implementation of a test.

U

Validation - Validation is a documented procedure and refers to the collection and evaluation of data over the whole process design phase up to commercial production. Validation is intended to ensure that a device/equipment delivers consistent results meeting pre-defined criteria.

Verification - Measured confirmation obtained by a test or substantiation showing that the requirements with regard to quality are met by the performance under real conditions.

Wear - Refers to the gradual removal of material from a solid surface by some kind of mechanical action, i.e. caused by contact or the relative movement between that surface and a solid, liquid or gaseous object. In other terms, the loss of material (removal of a portion of the surface) of an object by abrasion, rolling movements, impacts, scratching or chemical and thermal strain. Wear that cannot be avoided is limited to assemblies that can be easily replaced and that are subsumed under the term wear parts.

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Y

Zertifizierung - Verfahren, dass ein Produkt, ein Prozess oder eine Dienstleistung definierten Anforderungen entspricht.

Zuverlässigkeit - Die Fähigkeit eines Systems oder einer Komponente, die geforderten Funktionen gemäß den spezifizierten Funktionen auszuführen.