Best Practices in Quality and Compliance Management
Source: MetricStream
To successfully manage compliance , each regulated system must be proven to operate in accordance with its intended use and design, and all documentation supporting that evidence must culminate in FDA-acceptable documentation .
As a leading vendor of Quality and Compliance software , Metric Stream is helping many leading companies adopt a single enterprise wide compliance solution.
Why System Validation?
Current Good Manufacturing Practices (cGMP) are mandated by the FDA to ensure that the products manufactured by the industries such as
-
• Pharmaceutical,
• Biotech and
• Medical devices , to meet specific requirements for identity, strength, quality, and purity.
In order to comply with cGMP , companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs) and Master Production Batch Record (MPBR)
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