Glossar


ALCOA

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…

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Data

Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation.

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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…

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Data life cycle

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…

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Electronic record

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.

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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…

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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…

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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…

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