I've never met anyone who does not readily acknowledge the benefits of design controls
(21 CFR Part 820.
001 10 1 (Very low) Table 3: Recommended criterion to assess detection rank Detection Criterion: detection opportunity with Rank current controls Almost Current design controls
can't detect 10 impossible cause/mechanism and its subsequent failure mode or there is no design control
The quality system inspection technique was validated in the sequence: management controls, design controls
, CAPA, and production and process controls.
While a major obstacle in achieving improved product development performance is how to apply design control
processes without becoming overly bureaucratic, leading companies demonstrate a clear understanding of the intent behind design controls
and have structured their product development process accordingly.
Streamlining and simplification of tower design controls
for residential and commercial buildings along the Farley (34th Street) corridor;
Short of installing bulletproof barriers and expensive security monitoring systems, there are a number of environmental design controls
that help reduce the likelihood of an event.
for the Medical Device Industry examines successful product development models and superimposes the FDA requirements on them to provide a blueprint for an effective and compliant design control
The SprayStar vehicle and rate control system integrated into the design controls
many machine and solution system functions in an easy-to-read monitor.
Requirements for this standard include design controls
, process controls, special processes, traceability, record retention, and regulatory actions - all critical for the medical device industry.
Weren't these design controls
supposed to prevent this kind of outcome?
The all-nylon design controls
the expansion and shape of the duct in response to heat and pressure.
The CPC called for incorporation of urban design controls
to preserve light and air throughout the complex and its surroundings, make it easier for pedestrians to traverse the site and ensure the quality of the public realm.