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The FDA Guidance does not call for a specific process or lifecycle, but does describe
types of artefact and prescribes that certain activities must take place. As far as
possible, artifacts and activities are specified in terms of their outcomes and results
rather than specific content or actions being prescribed.
The FDA Guidance is not itself mandatory. It concentrates on the outcomes rather than
the processes. However, failure to comply to the Guidance will make it very difficult
to gain FDA approval.
The FDA Guidance identifies a number of activities and types of artifact (Work
Product). However, it does not specify any particular development approach, process or
lifecycle.
The process content in this configuration forms the base content for a solution (Design
Control) that satisfies the needs of the FDA and other regulators. This entails
customizing this content for each new project with project-specific information.
How to use the Mapping
We anticipate a number of different ways this content can be used. For this reason, we
support naviation from the Design Control elements to relevant process and practice
content in different ways.
Process assets provided within the library include:
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Tasks - include a description of the task, a set of inputs and outputs, the
identification of responsible and involve roles, and links to variance forms of
guidance to aid in the performance of the task.
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Work Products / Artifacts - are the things consumed or produced by tasks and are
the tangible results of those efforts.
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Roles - specify the responsibilities of jobs within the context of the process.
Roles may be assigned to tasks as primary or optional performers.
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General guidance - there are a number of different kinds of guidance, such as
checklists, term definitions, concepts, examples, and work product templates that
are provided.
Note
This content does not in itself guarantee that your processes and products will be
compliant. The purpose is to aid in the development of the work products and
performance of relevant tasks as specified in the FDA Guidance.
In preparing this material, we have quoted from FDA Guidance, but for the most part
have avoided wholesale copying of large sections. It is strongly recommended that this
material is used in conjunction with the FDA Guidance, it is not intended to replace
that guidance.
Acknowledgements
We wish to thank FDA for allowing us to use text from its material. We highly recommend
interested parties refer to this material from FDA at http://www.fda.gov.
FDA contact details:
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Call: 1-888-INFO-FDA (1-888-463-6332)
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Fax to 301-847-8622
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Address: FDA, 10903 New Hampshire Avenue (HFI-50), Silver Spring, MD 20993
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On-line comment
form
Legal Statement - Disclaimer
The practice mapping to FDA Guidance provided here can be used to help Licensee meet
compliance obligations, which may be based on laws, regulations, standards or
additional practices. Any directions, suggested usage, or guidance provided by the
practice mapping does not constitute legal, accounting, or other professional advice,
and Licensee is cautioned to obtain its own legal or other expert counsel. Licensee is
solely responsible for ensuring that Licensee and Licensee's activities, applications
and systems comply with all applicable laws, regulations, standards and practices. Use
of this practice mapping does not guarantee compliance with any law, regulation,
standard or additional practice.
In preparing these practices, we have drawn extensively on related guidance from FDA,
in accordance with FDA policies at:
Where possible, we reference and give links to FDA material, which should be regarded
as the source of record.
Linking To or Copying Information On the FDA Website
Unless otherwise noted, the contents of the FDA website (www.fda.gov12)--both text and
graphics--are not copyrighted. They are in the public domain and may be republished,
reprinted and otherwise used freely by anyone without the need to obtain permission
from FDA. Credit to the U.S. Food and Drug Administration as the source is appreciated
but not required. People are also free to link to any URL on FDA's site. FDA's
preference is that people link to the material on the FDA site (rather than copying it
to their personal websites) because the agency continuously updates the information on
the website as better information becomes available. A person copying documents to
another website, instead of linking to them, would then have to monitor the original
documents to know when these documents were updated by FDA or else risk giving bad or
incorrect advice to visitors to their website. Providing consumers or health
professionals with advice that is not fully up to date can lead to serious public
health consequences. Providing industry advice that is not fully up to date can lead to
companies being out of compliance with regulatory requirements.
If a person, nonetheless, decides to copy content or images, FDA strongly recommends
that the copied item lists the date that the material was copied and provides a link
back to its source on the FDA website. Users can then see for themselves if the copied
material has been updated or changed.
FDA appreciates being informed about the use of website materials. Contact FDA, HFI-50,
Rockville, MD 20857 or email mailto:webmail@oc.fda.gov.
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