PDA Technical Glossary
PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.
The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.
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Static Record Format (FDA)
A fixed-data document such as a paper record or an electronic image.(TR80)
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Static Record Format (MHRA)
A "fixed" record such as paper or pdf. (TR80)
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Static Record Format (WHO)
A static record format, such as a paper or pdf record, is one that is fixed and allows little or no interaction between the user and the record content (TR80)
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Systems (in computer or related systems) (FDA, attributed to ANSI)
People, machines, and methods organized to accomplish a set of specific functions. Computer or related systems can refer to computer hardware, software, peripheral devices, networks, cloud infrastructure, operators, and associated documents(e.g., user manuals and standard operating procedures).(TR80)
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Systems (in computer or related systems) (WHO)
A computerized system collectively controls the performance of one or more automated processes and/or functions. It includes computer hardware, software, peripheral devices, networks and documentation, e.g., manuals and standard operating procedures, as well as the personnel interfacing with the hardware and software, e.g., users and information technology support personnel.(TR80)