Internal Auditors: Step up to the plate
The article published in the “IIA magazine” recently, written by experts, discusses how internal auditors have the opportunity to play a fundamental role in directing company strategy and enabling it to move forward into a new era of profitability.
Are You Ready for the HIPAA Compliance Audits?
The Health Care Compliance Association (HCCA)’s leading magazine “Compliance Today” publishes articles written by experts belonging to various fields from the Healthcare and Life Sciences Industry, sharing insights on compliance, ethics, information security and privacy related issues that are relevant concerns in these industries.
Corrective Action (CAPA) Systems At Innovative Companies
In a manufacturing organization, when Deviations, Nonconformance, Out of Specifications, Incidents or Complaints occur, Corrective and Preventive Actions need to be initiated to remedy the problem. Once a CAPA has been initiated, it follows its assigned workflow process. Ensuring Regulatory Compliance Through Training And Certification
Often, it is lack of proper employee training that leads to actions causing non-compliance, resulting in stiff penalties. Hence, a critical success factor for regulatory compliance is keeping the workforce well trained. Erm Analysis For Credit Ratings Of Nonfinancial Companies: Stepping Up To New Criteria
Patterned on the approach already used for sectors like finance, insurance and energy since 2004, SnP's announcement proposes to employ 100 or so different factors to evaluate the quality of ERM operations in nonfinancial institutions and then include that assessment in their final score. GXP Compliance
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A supplier's certification to ISO/TS 16949:2002 will satisfy vehicle manufacturers' current quality system requirements for compliance or certification. How To Build A Business Case For A Quality Management System
The goal of the business case is to ensure that the project delivers value greater than the corporate hurdle rate for capital investments. This paper provides a proven step-by-step process to developing a business case for a Quality Management System (QMS) within an enterprise. How To Give A Quality Score To Your Supplier
A supplier scorecard contains categories or main groupings of metrics by which suppliers are measured. These categories include quality, delivery, cost, and responsiveness. Aggregated score for each category is calculated first, providing a company visibility into quality score, delivery score, etc. Impact Of Regulatory Compliance On Quality And Profits - Gunjan Sinha, Chairman, Metricstream Inc.
While the issue of cost of compliance to consumers and tax paying citizens is a well-researched fact, the cost of non-compliance is still an uncharted area measured mostly by fines and penalties paid by corporations. Those opposing the pressure of compliance, often argue that regulations only expand the bureaucracy, adding burden to its subjects or on the industries it regulates. Implementing A Well Designed Audit Program
Best practices for incorporating audits into your operational framework and how to most effectively implement audits in a global organization. Incorporating Audits In Your Operational Framework - Gunjan Sinha, Chairman, Metricstream Inc.
Audit is not a responsibility of the internal or external auditors. It is the responsibility of business heads and managers who are running the operations of the company, on a day-to-day basis. Incorporating Quality Into Management Style - Gunjan Sinha, Chairman, Metricstream Inc.
In progressive companies, managers are not merely focused on enhancing organizational output and productivity, but are also aware of achieving greater degree of compliance and quality to the regulatory frameworks of their industries, economies and communities. IT Systems Validation For Sox And Regulatory Compliance
Information technology has become a core enabler of business processes within the organizations today. As a result, companies are required to audit and validate their relevant IT systems to ensure that their business processes and underlying records comply with regulations such as the Sarbanes-Oxley Act of 2002 or Healthcare Insurance Portability and Accountability Act (HIPAA) or 21 CFR Part 11 (FDA). Leveraging Auditing Standard No.5 To Streamline Sox Compliance
The soaring SOX costs have not gone unnoticed by the Public Company Accounting Oversight Board (PCAOB). The PCAOB has seen how the accounting firms have run up huge fees, and forced clients to spend millions of dollars on redundant IT systems and unnecessary controls Managing Quality At Outsourced Manufacturing Operations
The need for enterprise quality management is amplified for companies in the technology industry. These companies have increasingly shifted manufacturing and assembly operations offshore to low cost countries or have outsourced these functions to a contract manufacturer. New User Access Requirements For 100% Compliance
By removing any barriers to easy access and use, companies can ensure 100% adoption of the application. This paper addresses how the next generations of compliance systems are addressing these key issues.
