Implement industry best practices and proven methodologies
The pharmaceutical industry is constantly challenged to meet the rising standards of quality, and comply with rigorous regulatory requirements. These requirements include FDA GXPs and reporting mandates, international drug safety standards, and cross-industry compliance requirements stipulated by laws such as SOX . Compliance is evolving from an isolated departmental initiative to an enterprise level risk management challenge.
MetricStream offers integrated solutions for successfully meeting these requirements while lowering the associated costs that can otherwise be substantial. The solutions uniquely combine software and content for effective and sustainable compliance. They include best practice templates, access to training content from an expert community, and integration of business processes with regulatory notifications and industry alerts.
MetricStream solutions are widely used in the life sciences industry for supporting key processes and requirements for compliance at various stages.
Pre-market Stage: FDA conducts comprehensive evaluations of a New Drug Application (NDA) based on the data and documentation provided for drug safety and efficacy, risk management, and GXP compliance issues for clinical, laboratory, and manufacturing procedures.
Risk Management: MetricStream solutions allow customers to reduce development risks and accelerate approval cycles by capturing and tracking potential safety issues, assessing risks, and implementing corrective actions . The solution also helps identify potential quality issues by using trending and data analytics.
Drug Manufacturing: 21 CFR Part 210 and 211 states that the...minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess and ...failure to comply, shall be subject to regulatory action. MetricStream reduces GXP non-compliance risks by creating a transparent environment for proactively identifying, tracking and resolving quality issues.
Post-market Surveillance: Pharmacovigilance examines issues of drug safety and efficacy (after they are introduced in the market), and focuses on identifying and investigating adverse events. MetricStream provides a comprehensive solution for automating pharmacovigilance processes to record , investigate, and report cases as per the adverse event reporting guidelines mandated by the FDA and other international regulatory bodies.
Risk and Compliance Management: The MetricStream solution provides an integrated and flexible framework for risk assessment and its documentation , control definition , audit management , issue detection, and execution of recommendations and remediation plans. The system also includes powerful tools such as configurable risk calculators and risk heat maps to analyze and monitor risk.
Benefits of MetricStream Solutions:
Faster Time-to-market: The solution accelerates production and release cycles by providing real-time visibility into the quality and document management process and key performance metrics.
Reduced Costs: The solution lowers the cost of regulatory compliance and poor quality by building operational efficiencies in quality systems.
Improved Processes: The solution proactively identifies tracks, and resolves quality and compliance issues by creating a transparent environment where decisions are based on hard facts and metrics.
Reduced Non-compliance Risk: An integrated system -oriented approach is enabled wherein compliance is built into each system to adhere to regulations and standards for the pharmaceutical and life sciences industry such as FDA 21 CFR Part 11, Part 210-211 and ICH Q7A