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Regulated companies are subjected to various regulations, guidelines and quality standards. The GxP guidelines (established by the United States Food and Drug Administration (FDA) and used around the world) are designed to ensure that products are safe, meet their intended use and adhere to quality processes during development, manufacturing, control, storage and distribution.

The GAMP (Good Automated Manufacturing Practice) guidance document is a risk-based approach to compliant GxP computerized systems and offers guidance to align with regulatory requirements.

The GAMP©5 guidelines state that “quality risk management is a systematic process for the assessment, control, communication, and review of risks to patient safety, product quality, and data integrity” (GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems. Page 105, Appendix M3.)

During all phases of a system life cycle, an initial risk assessment is the first step in quality risk management to identify Critical Quality Attributes (CQA) and Critical Process Parameters (CPP).

Critical Quality Attributes (CQA) can be chemical, physical, biological and microbiological attributes that can be defined, measured, and continually monitored to ensure final product outputs remain within acceptable quality limits.

Critical Process Parameters (CPP) are key variables affecting production processes. CPP are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in Critical Quality Attributes.

Environmental Monitoring Systems are put in place to monitor critical environmental parameters (but not limited to only critical parameters).

•RMS is developed based upon the GAMP©5 recommendations.

•RMS is FDA CFR 21 Part 11 compliant.

•RMS is FDA CFR 21 Part 210 and 211 compliant.

•RMS is EU Annex 11 compliant.

•RMS is a validatable software and can be validated based upon the EU Annex 15 requirements.

•RMS is ISO 14644-1/2 compliant.