Best Practices in Quality and Compliance Management

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)