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MasterControl Out-of-Specification™

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Data Sheet 1 Data Sheet MasterControl Out-of-Specification™ (OOS) In the FDA environment, specifications are essential in maintaining quality. CGMP regulations for finished pharmaceuticals, specifically 21 CFR Parts 210-211, require strict conformance to approved specifications. The Out-of- Specification (OOS) software solution from MasterControl Inc. automates OOS processes to help companies comply with FDA CGMPs and 21 CFR Part 211 regulatory requirements. Under Parts 210-211, acceptance or rejection of a product rests, to a large extent, on the product's adherence to specifications. For example, testing for conformity to written specifications is required for every component of the product (Sec. 211.84). In the same vein, finished drug products that fail to meet established standards, specifications, or other relevant quality control criteria will be rejected (Sec. 211.165). Where there's an out-of-specification test result, an investigation must be conducted and its results documented (Sec.211.192). In addition, the FDA has issued a guidance called "Investigating Out-of-Specification Test Results for Pharmaceutical Production," which reinforces the importance of appropriate handling of OOS. The guidance applies to chemistry-based laboratory testing performed on active pharmaceutical ingredients (API), excipients and other components, in-process materials, and finished drug products. How Can MasterControl Software Solutions Help You? Many of MasterControl's FDA-regulated customers rely on our integrated solutions suite to automate the process of collecting and controlling data critical to compliance. MasterControl OOS offers the necessary flexibility in terms of design, routing, and user and security roles. It provides advanced tracking functionality, incorporates escalation, and offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Data captured on forms is automatically entered in an ODBC-compliant database and can be used for analysis.

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