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2. Good automated manufacturing practice - Wikipedia

   en.wikipedia.org/wiki/Good_Automated...

   More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...

3. Process analytical technology - Wikipedia

   en.wikipedia.org/wiki/Process_analytical_technology

   Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).

4. Change control - Wikipedia

   en.wikipedia.org/wiki/Change_control

   Within quality management systems (QMS) and information technology (IT) systems, change control is a process—either formal or informal [1] —used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without ...

5. Zamzar - Wikipedia

   en.wikipedia.org/wiki/Zamzar

   Zamzar is currently free to use, but there is a limit of two conversions per hour for files up to 100MB. Users can pay a monthly subscription in order to access preferential features, such as unlimited file conversions, online file management, shorter response and queuing times and other benefits.

6. Consolidated Clinical Document Architecture - Wikipedia

   en.wikipedia.org/wiki/Consolidated_Clinical...

   The HL7 Consolidated Clinical Document Architecture (C-CDA) is an XML-based markup standard which provides a library of CDA formatted documents. Clinical documents using the C-CDA standards are exchanged billions of times annually in the United States.

7. Good documentation practice - Wikipedia

   en.wikipedia.org/wiki/Good_documentation_practice

   Avoiding asterisks as part of the notation of a hand-change – where insufficient white space permits a fully notated hand change, a common practice is to use an asterisk (or other mark) near the correction, and elsewhere record the same mark and the notation. The risk is that additional changes are made by another person who uses the same ...