Glossar Archiv » QFINITY

A C D E I P Q

ALCOA

ALCOA is a common acronym for representing data integrity by meeting the following criteria: Attributable / attributable (i.e., source identification – human or technology) Legible / readable (and understandable) Contemporaneous (i.e. immediately recorded) Original (handwritten records or certified / true…

Audit

An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. If you need more information about audits please contact us here.…

Coding

Generating the program code to create software modules. The coding is subject to programming guidelines, which define the quality requirements for code generation and thus ensure the traceability of the program code. The correctness of the generated code is verified…

Computer

A Computer is a functional unit that can perform substantial computations, including numerous arithmetic operations and logic operations without human intervention. If you need more information please contact us here.…

Computer Software Assurance (CSA)

The CSA approach is a method to scale the documentation efforts for test activities according to risk associated with the function to be tested. High-Risk functions should be tested more extensively with higher control in a fully scripted test. Low…

Computerized System

A Computerized System is a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and…

Computerized System Validation

Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by: the adoption of principles, approaches, and life cycle activities within the validation…

Computersystem

A Computersystem is a system containing one or more computers (or hardware components) and associated software. If you need more information about computersystems contact us here.…

Critical Thinking

Critical thinking is a systematic, rational, and disciplined process of evaluating information from a variety of perspectives to yield a balanced and well-reasoned answer. Critical thinking promotes informed decision-making and good judgment about where and how to apply and scale…

Data

Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.…

Data Integrity

Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance…

Data life cycle

Data life cycle is a planned approach to assessing and managing data risks in a way that reflects the potential impact on Product quality, Patient safety and/or the reliability of the decisions taken in all phases of the process in…

Electronic record

Electronic record describes any combination of text, graphics, data, audio, images or other informational representations in digital format generated, modified, maintained, archived, accessed or distributed by computerized systems. If you want more information about electronic record contact us here.…

Integration

Integration describes the building of hardware and/or implementation of software components to create a complete system. Integration tests check the function and interaction of the individual components. For more information about integration contact us here.…

Process

Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.…

Process Validation

Process validation means 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. For more information and details about process validation contact us here.…

QFINITY

QFINITY provides expertise and support for pharmaceutical and medical device companies along the entire product or service lifecycle. Our focus is on developing and optimizing quality management system and IT system strategies to support continuous improvement, (business) process management and…

Quality

The term quality is derived from the Latin word “qualitas”, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means…

Quality management

Quality Management (QM) refers to all organizational measures that relate to the structure of the organization and the efficient execution of processes at various levels of the company. With consistent implementation, quality management enables the continuous improvement of corporate culture,…