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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 ...
A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. [4] However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 [ 5 ] The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the ...
Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7; Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X; Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5; Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828 ...
Template documentation Usage Although there are over two hundred Wikipedia guidelines, this sidebar contains the most foundational or frequently referenced, organized by the categories defined in Wikipedia:List of guidelines , some of which are headings and the others contained under the heading "Other".
Software configuration management (SCM), a.k.a. software change and configuration management (SCCM), [1] is the software engineering practice of tracking and controlling changes to a software system; part of the larger cross-disciplinary field of configuration management (CM). [2] SCM includes version control and the establishment of baselines.
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product.
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).
A change request is declarative, i.e. it states what needs to be accomplished, but leaves out how the change should be carried out. Important elements of a change request are an ID, the customer (ID), the deadline (if applicable), an indication whether the change is required or optional, the change type (often chosen from a domain-specific ontology) and a change abstract, which is a piece of ...