Pharmaceutical

The pharmaceutical industry is constantly being challenged to meet the rising standards of quality and to comply with rigorous regulatory requirements. Regulatory requirements include FDA GXPs and reporting mandates, international drug safety standards, and cross-industry compliance requirements stipulated by laws such as Sarbanes Oxley Act (SOx). Compliance is evolving from an isolated departmental initiative to an enterprise level Risk Management challenge.

MetricStream offers an integrated solution for successfully meeting these requirements while lowering the associated costs that can otherwise be substantial. MetricStream uniquely combines software and content to deliver solutions for effective and sustainable compliance with embedded best practices templates, access to training content from an expert community, and integration of business processes with regulatory notifications and industry alerts.

Related Solutions ISO 9000 Compliance Internal Quality Nonconformance & CAPA Management   Complaints Management Variance & OOS Management   SOx Compliance FDA Compliance       more ...

MetricStream solutions are widely being used in the life science industry for supporting key processes and requirements for compliance at various stages.

Pre-Market Stage: FDA conducts comprehensive evaluation 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, manufacturing procedures. MetricStream solutions allow customers to reduce their development risks and accelerate approval cycles by enabling them to capture and track potential safety issues, assess risks and implement corrective actions, and identify potential quality issues by using trending and data analytics.

Drug Manufacturing: 21CFR Part 210 and 211 define 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 safety and efficacy of drugs 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 records, investigate, and report cases as per the adverse event reporting guidelines mandated by the FDA and other international regulatory bodies.

Risk Management: MetricStream provides an integrated and flexible framework for documenting and assessing risks, defining controls, managing audits, identifying issues and implementing recommendations and remediation plans. The system includes powerful tools for risk analysis and monitoring such as configurable risk calculators and risk heat maps.

Key benefits realized by MetricStream customers include:

Faster time-to-market: Accelerate production and release cycle by gaining real-time visibility into the quality and document management process and its key performance metrics.

Reduce Costs: Lower the cost of regulatory compliance and the cost of poor quality by building operational efficiencies in quality systems.

Improve Processes: Proactively identify, track and resolve quality and compliance issues by creating a transparent environment where decisions are based on hard facts and metrics.

Reduce Noncompliance Risk: Adopt an integrated systems-oriented approach that has compliance built into each system to adhere to regulations and standards such as FDA 21 CFR Part 11, Part 210-211 and ICH Q7A.