Regulatory Compliance Solution
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  SOLUTIONS
Quality Management
Regulatory Compliance
SOx Compliance
FDA Compliance
FERC Compliance
FAA Compliance
OMB A-123 Compliance
Environmental Health & Safety
HACCP & ISO 22000 Compliance
Data Retention Compliance
Consumer Privacy
BSA, Patriot Act
Risk Management
Corporate Governance
  FEATURED INDUSTRIES
Pharmaceutical
Medical Devices
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Regulatory Compliance Solutions

Compliance requirements are affecting increasing number of business processes with many specialized processes being designed solely to meet industry specific regulations. As various compliance initiatives become more intertwined from regulatory and organizational perspectives, multiple and disparate solutions lead to duplicative, and often contradictory, processes and documentation. Such environments do not provide clear visibility into the organizations' risk and compliance profile, bring down efficiency, and escalate the cost of compliance.

MetricStream provides a common framework and an integrated approach to meet cross-industry mandates and regulations such as OSHA, EH&S, FCPA, and ISO standard as well as the industry focused regulatory guidelines from FDA, FERC, FAA, HACCP, OMB A-123, AML, Basel II and Data Retention laws.

MetricStream regulatory compliance solution also supports implementing key program for compliance management through document control, compliance training, ongoing auditing, as well as recording and reporting of exception events and the resulting corrective actions.

Role-based dashboards, control diagrams, and scorecards provide visibility into the ongoing compliance efforts and bring high-risk areas into focus. The solution has the ability to track process ownership, assessment plans, remediation status, etc. on graphical charts with real-time information that can be accessed globally. Ability to drill-down to deeper levels of information with a single click provides an easy way to access the data at finer levels of detail.

In addition, 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 or industry alerts.

Regulatory Compliance Solutions
SOx Compliance FDA Compliance
FERC Compliance   FAA Compliance
OMB A-123 Compliance   Environmental Health & Safety
HACCP & ISO 22000 Compliance   Data Retention Compliance
Consumer Privacy   BSA, Patriot Act
Webinars

Achieving cGMP Compliance - a case study

Automating the Corrective Action Process


White Papers

Quality assurance and regulatory compliance across the extended enterprise

Meeting 21 CFR Part 11 Requirements

Enhance quality tracking and process efficiency optimization in pharmaceutical manufacturing

An Overview of cGMP Policies for Quality Management


Datasheets

QualityStream Document Management Module

Pharmaceutical

Medical Devices


Insights

Automating the process of Regulatory Compliance for Medical Devices

Supplier Quality Management in FDA-regulated Industry