Glossary
| Term | Definition |
|---|---|
| 21CFR | US Regulation 21 CFR, Part 11 Electronic Records, Electronic Signatures |
| Acceptance test | Acceptance Test. Formal testing of user requirements and needs or business processes. It is performed to allow a contracting authority or an authorized entity to make a decision based on the acceptance criteria of whether or not to accept a system [according to IEEE 610.12]. |
|
Equivalence partitioning |
A black-box test technique in which test cases are designed to exercise equivalence partitions by using one representative member of each partition. |
| Behavior-Driven Development | Behavior-driven development (BDD) is a software development methodology in which an application is specified and designed describing how its behaviorshould appear to an outside observer. Real-life examples gleaned from stakeholders are converted into acceptance criteria with validation tests that are often automated. |
| Black box testing | Testing, either functional or non-functional, without reference to the internal structure of the component or system. |
| Business Analysis | The practice of enabling change in the context of an enterprise by defining needs and recommending solutions that deliver value to stakeholders. |
| Certified copy | 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. Source; US FDA, Electronic Source Data in Clinical lnvestigations, September,2013. |
| Certified copy | A copy of original information that has been verified as an exact (accurate and complete) copy having all of the same attributes, and information, as the original. The copy may be verified by dated signature or by a validated electronic process. Source: CDl5C, (Clinical Data lnterchange Standards Consortium) Clinical Research Clossary Version 8.0, December, 2009. |
| CMMI | A framework that describes key elements of effective software development and maintenance. CMMI covers best practice approaches for planning, engineering and managing software development and maintenance. CMMI was designed as a successor to CMM (Capability Maturity Model). |
| Computerized system transaction | A computer system transaction is a sinlge operation or sequence of operations performed as a single logical "unit of work." The operation(s) that make up transaction may not be saved as a permanent record on durable storage until the user commits the transaction through a deliberate act (e.g., pressing a save button), or until the system forces the saving of data. The metadata (i.e., user name, data, and time) is not captured in the system audit trail until the user commits the transaction. In Manufacturing Execution Systems (MES), an electonic signature is often required by the system in order for the record to be saved and become permanent. |
| Critcal data | Data with high risk to product quality or Patient safety. Source: ISPE CAMP COP, Annex 11 lnterpretation, JulylAugust,2011- |
| Data | lnformation derived or obtained from raw data (e.g., a reported analytical result). |
| Data governance | The sum total of arrangements to ensure that data, irrespective of the format in which they are generated, are recorded, processed, retained, and used to ensure a complete, consistent, and accurate record throughout the data life cycle. |
| Data life cycle | All phases in the life of the data (including raw data) from initial generation and recording through processing (including transformation or migration), use, data retention. archive/retrieval, and destruction. |
| Design Qualification | Documented process of checking the project orientation documents for compliance with the given quality and execution requirements of the operator and compliance with GMP aspects. |
| Electronic source data | Data initially recorded in electronic format. Source US FDA CFR, Electronic Source Data in Clinical Investitations, September, 2013. |
| ERP | Enterprise Resource Planning System |
| Explorative Testing | An informal test where the tester actively controls the design of the test by testing and using the information he receives during test execution to design new, better tests [Bach 04] |
| FDA | US Food and Drug Administration |
| FRA | Functional Risk Assessment |
| GAMP | Good Automated Manufacturing Practice |
| Hazard | Potential source of harm [ISO/IEC Guide 51] |
| GxP | The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics. The most central aspects of GxP are: Traceability: the ability to reconstruct the development history of a drug or medical device. Accountability: the ability to resolve who has contributed what to the development and when. Documentation is a critical tool for ensuring GxP adherence. Examples: Good automated manufacturing practice (GAMP) Good Manufacturing Practice (GMP) Good Clinical Practice (GCP) Good Laboratory Practice (GLP) Good Distribution Practice (GDP) Good Quality Practice (GQP) Good Pharmacovigilance Practice (GVP) |
| ICH | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use |
| IEEE | Institute of Electrical and Electronics Engineers assocation |
| Installation Qualification(IQ) | Documented verification that a system is installed according to written and pre-approved specifications. |
| Integration testing | Testing performed to expose defects in the interfaces and in the interactions between integrated components or systems. |
| IRA | Initial Risk Assessment |
| IREB | Internation Requirements Engineering Board |
| ISO | International Organization for Standardization |
| ISTQB | International Software Testing Qualifications Board |
| Metadata | A description of data to help understand how to use that data, either in terms of the structure and specification of the data, or the description of a specific instance of an object. |
| MD Directive | Medical Devices Directive |
| Operational Qualification (OQ) | Documented verification that a system operates according to written and pre-approved specifications throughout all specified operating ranges. |
| Original record | Data as the file or format in which it was originally generated, preserving the integrity (accuracy, completeness, content, and meaning) of the record, e.g., original paper record of manual recording of an observation or electronic raw data file from a computerized system. |
| Performance Qualification (PQ) | Documented verification that a system is capable of performing or controlling the activities of the processes it is required to perform or control, according to written and pre-approved specifications, while operating in its specified operating environment. |
| PIC/S | Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme |
| Primary record | The record that takes primacy in cases where data is collected and retained concurrently by more than one method. A risk assessment respectively risk management has to ensure that the so-defined primary records have the maximum possible accuracy, completeness and relevance. It is not allowed to define so-called static data (prints or manual records), if there are dynamic (electronic) data as primary records. If there are data anomalies (e.g. OOS results), all data (static and dynamic) will have to be included in a risk-based investigation. |
| QSR | Quality System Regulations |
| RAM | Requirements Abstraction Model |
| Raw data | Original records and documentation retained in the format in which they were originally Eenerated (i.e., paper or electronic), or as a "true copy." Raw data must be contemporaneously and accurately recorded by permanent means. ln the case of basic electronic equipment, which does not store electronic data, or provides only a printed data output (e.g., balance or pH meter), the printout constitutes the raw data. |
| Raw data | All data on which quality decisions are based should be defined as raw data. It includes data that is used to generate other records. Source: Eudralex, Vol- 4, Good Manufacturing Practice Medicinal Products fot Human and Vete narY Use. Chapter4, June,2011. |
| Raw data | Any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a non clinical laboratory study, and are necessary for the reconstruction and evaluation of the report of that study. ln the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments. Source: US FDA, Code of Federal Regulations, title 21, Vol. 1, part 58, subpart A, section 58.3(k), April,2015. |
| Records | Records are made, manually and/or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected. Source: EudraLex ,Vol. 4, Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Chapter 1, June, 2011. |
| Records | Provide evidence of various actions taken to demonstrate compliance with instructions, for example, activities, events, investigations, and in the case of manufactured batches, a history of each batch of producl including its distribution. Records include the raw data which are used to generate other records. For data regulated users should define which data are to be used as raw data. At least, all data, on which quality decisions are based, should be defined as raw data. Source: Eudralex,Vol. 4, Good Manufacturing Practice Medicinal Products for Human and VeterinarY Use, Chapter4, June, 2011. |
| Risk | The combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51). |
| SAP | German software development company for business and entrepries software |
| Source data | All information in original records, and certified copies of original records of clinical findings, observations, or other activities in a clinical trial, necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). Source: EMtulNS 1CCP145428012010 (GCP IWC), June, 2010. |
| Source data | All information in original records and certified copies of original records of clinical findings, observations, or other activities (in a clinical investigation) used for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). Source: US FDA CFR, Electronic Source Data in Clinical I nvestigations, September, 2013. |
| System Testing | Testing an integrated system to verify that it meets specified requirements. |
| TPI (Next) | A continuous business-driven framework for test process improvement that describes the key elements of an effective and efficient test process. |
| True copy | An exact verified copy of an original record. Data may be static (e.g, a "fixed" record such as Paper or pdf) or dynamic (e.g., an e-record that the user/reviewer can interact with). |
| Unit testing | The testing of individual hardware or software components. |
| Validation Report | Documented evidence that the business and regulatory requirements for a specific intended use or application have been met. |
| Validation Plan | Description of the necessary verification and validation activities that meet the requirements for a specific intended use or application by providing objective evidence. |
| White-box test | Testing based on an analysis of the internal structure of the component or system. |