A translation memory (TM) is a database that stores "segments", which can be sentences, paragraphs or sentence-like units that have previously been translated, in order to aid human translators. The translation memory stores the source text and its corresponding translation in language pairs called “translation units”. Individual words are handled by terminology bases and are not within the domain of TM.
A document management system (DMS) is usually a computerized system used to store, share, track and manage files or documents. Some systems include history tracking where a log of the various versions created and modified by different users is recorded. The term has some overlap with the concepts of content management systems. It is often viewed as a component of enterprise content management (ECM) systems and related to digital asset management, document imaging, workflow systems and records management systems.
In computing, internationalization and localization (American) or internationalisation and localisation, often abbreviated i18n and L10n, are means of adapting computer software to different languages, regional peculiarities and technical requirements of a target locale.
Documentation is any communicable material that is used to describe, explain or instruct regarding some attributes of an object, system or procedure, such as its parts, assembly, installation, maintenance and use. As a form of knowledge management and knowledge organization, documentation can be provided on paper, online, or on digital or analog media, such as audio tape or CDs. Examples are user guides, white papers, online help, and quick-reference guides. Paper or hard-copy documentation has become less common. Documentation is often distributed via websites, software products, and other online applications.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
A medical classification is used to transform descriptions of medical diagnoses or procedures into standardized statistical code in a process known as clinical coding. Diagnosis classifications list diagnosis codes, which are used to track diseases and other health conditions, inclusive of chronic diseases such as diabetes mellitus and heart disease, and infectious diseases such as norovirus, the flu, and athlete's foot. Procedure classifications list procedure code, which are used to capture interventional data. These diagnosis and procedure codes are used by health care providers, government health programs, private health insurance companies, workers' compensation carriers, software developers, and others for a variety of applications in medicine, public health and medical informatics, including:
A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for safety information data entry, retrieval, evaluation, and presentation. Also, it is the adverse event classification dictionary.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
A medical writer, also referred to as medical communicator, is a person who applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe research results, product use, and other medical information. The medical writer develops any of the five modules of the Common Technical Document. The medical writers also ensure that their documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure.
Medical transcription, also known as MT, is an allied health profession dealing with the process of transcribing voice-recorded medical reports that are dictated by physicians, nurses and other healthcare practitioners. Medical reports can be voice files, notes taken during a lecture, or other spoken material. These are dictated over the phone or uploaded digitally via the Internet or through smart phone apps.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. A specification is often a type of technical standard.
The Federal Institute for Drugs and Medical Devices is the medical regulatory body in Germany. It operates under the Federal Ministry of Health (BMG). It is headquartered in Bonn, Germany. Its president is Prof. Dr. Karl Broich.
Technical translation is a type of specialized translation involving the translation of documents produced by technical writers, or more specifically, texts which relate to technological subject areas or texts which deal with the practical application of scientific and technological information. While the presence of specialized terminology is a feature of technical texts, specialized terminology alone is not sufficient for classifying a text as "technical" since numerous disciplines and subjects which are not "technical" possess what can be regarded as specialized terminology. Technical translation covers the translation of many kinds of specialized texts and requires a high level of subject knowledge and mastery of the relevant terminology and writing conventions.
Technical documentation is a generic term for the classes of information created to describe the use, functionality or architecture of a product, system or service.
Pharmaceutical packaging is the packages and the packaging processes for pharmaceutical preparations. It involves all of the operations from production through drug distribution channels to the end consumer.
Linguistic validation is the process of investigating the reliability, conceptual equivalence, and content validity of translations of patient-reported outcome (PRO) measures.
Medical translation is the practice of translating various documents—training materials, medical bulletins, drug data sheets, etc.—for health care, medical devices, marketing, or for clinical, regulatory, and technical documentation. Most countries require that companies and organizations translate literature and labeling for medical devices or pharmaceuticals into their national language. Documents for clinical trials often require translation for local clinicians, patients, and regulatory representatives. Regulatory approval submissions typically must be translated. In addition to linguistic skills, medical translation requires specific training and subject matter knowledge because of the highly technical, sensitive, and regulated nature of medical texts.
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.
