Featured White Papers
Meeting 21 CFR Part 11 Requirements
Food and Drug Administration (FDA) introduced 21 CFR Part 11 (Part 11) regulations to promote wide usage of electronic technology in the life sciences industry in a way that is compatible with FDA's responsibility to protect public health. This paper discusses the various specifications of this regulatuions and suggests ways to address the Part 11 requirements in a cost efficient manner.
Quality assurance and regulatory compliance across the extended enterprise
Achieving enterprise-wide quality requires the collection of key metrics from disparate and disconnected sources in the enterprise.This could come from production, quality assurance,engineering, customer service and purchasing departments. This paper discusses why it is essential for organizations to have a web-based system to help them integrate, automate and provide visibility into these metrics from across the enterprise.
Enterprise Quality Management: Automotive issues and perspectives
Compliance to different quality system requirements, the complex nature of requirements and multiplicity of specifications placed a significant burden on automotive suppliers, adding to their cost of compliance. This paper discusses the evolution of the regulatory framework for the automotive industry, the recent regulatory challenges and a cost efficient way to address these requirements.
An Overview of cGMP Policies for Quality Management
Over the last 25 years there have been fewer FDA inspections and significant changes in government regulations and drug manufacturing processes. With technological advances in pharmaceutical sciences and manufacturing technologies, a risk-based approach to regulation and efforts towards global harmonization, the new regulatory initiatives for FDA compliance will impact greatly.
Effective Complaints Management in Healthcare
Complaints are inherent in every work environment but in healthcare services, complaints are critical, needing immediate resolution. This white paper presents the benefits of implementing a complaints management system in healthcare administration. It also describes the essential features of a best-in-class complaints management solution.
Corrective and Preventive Actions
Implementing a Corrective and Preventive Action (CAPA) system can help overcome operational risks by realigning data and obviating errors but it will go only to the extent to which it has been integrated with the rest of the support systems and policies of the hospital. This white paper gives a clear understanding of the challenges being faced by the healthcare providers today, how CAPA processes and systems can provide a solution and the features that a best-in-class CAPA solution must provide.
Integrated Risk and Compliance Management for Banks and Financial Services Organizations: Benefits of a Holistic Approach
Banks and financial services organizations of all sizes are now more concerned than ever about risk and compliance management. This white paper discusses the current risk and compliance environment for banks and financial institutions, strategies for successfully implementing Governance, Risk and Compliance (GRC) programs and how technology can be leveraged to adopt a holistic approach to risk and compliance management.
Quality and compliance in USDA regulated industries
In order to compete in today's global marketplace, food manufacturers and food service operators need to increase their productivity and ensure enterprise-wide quality and compliance. The most effective way to accomplish these objectives is by incorporating the principles of quality and compliance management into the overall corporate strategy. This paper discusses the various challenges in this industry and how an IT system can play a vital role in achieving the corporate goals for quality.
Governance, Risk and Compliance Framework
Growing regulatory environment, higher business complexity and increased focus on accountability have led enterprises to pursue a broad range of governance, risk and compliance initiatives across the organization. However, these initiatives are uncoordinated and potentially increase the overall business risk for the organization. This is leading organizations to take a unified approach to GRC. This paper details the various steps and benefits of implementing Unified GRC strategy.
Greening Supply Chain
The worlds best scientists have been warning - that climate change is happening faster and will bring bigger changes quicker than anticipated. Ironically market and the nature hitting the wall at once, is a sign that we need to find better ways to be more sustainable. Whether the drive is to comply with the government regulations or to meet the customers’ expectations companies are finding motivation to go green.
Quality management for multisite manufacturing
"The hi-tech industry is the motor for economic growth worldwide, setting a scorching pace in developing, producing, and marketing its hi-tech quality products across the globe. This paper discusses the various quality standards pertaining to the hi-tech industry and why a Hi-tech enterprise plan requires an effective global quality management system to manage the entire spectrum of activities towards final delivery."
Quality and compliance for the hi-tech industry
The High Tech industry faces dynamic challenges with shrinking product life cycles, and demands for constant product innovation. This paper discusses the need for an enterprise-class quality management system to forge better understanding between customers and vendors across the extended enterprise while helping the enterprise reduce nonconformance issues and comply with regulations and standards.
ISO 9000 - An Integrated Approach
The primary focus of ISO 9000 is to develop a proactive approach to preventing defects or errors or deficiencies in manufacturing of products or provisioning of services. This paper discusses the relevance of ISO 9000 to a corporate strategy, the implementation strategy and the best practices to maximize the value.
ISO/TS-16949:2002 - Transition to a global automotive industry quality management system
This paper discusses the requirements of the quality standard - ISO/TS 16949:2002, the challenges of transitioning to ISO/TS 16949:2002 and the various ways to address the probable issues.
Quality and compliance in the medical device industry: issues and perspectives
"The strong emphasis on quality in medical device manufacturing imposes stringent demands on the design and validation processes, as well as the packaging and logistics aspects. Furthermore, this industry is strictly FDA-regulated, and regulatory certification and compliance monitoring are critical needs to establishing strong customer and market credibility. This paper lists the challenges faced today by medical device manufacturers and the possible solutions to the problems."
Enterprise-wide CAPA management to help comply with FDA requirements
FDA's Quality System Inspection Technique (QSIT) is the primary inspection program for the medical device industry. The FDA views CAPA as being directly linked to all of the other subsystems and the FDA code for CAPA defined by 21 CFR 820.100 requires strict control and management of these corrective and preventive actions. This paper discusses the importance of IT systems in implementing CAPA across the Enterprise for Medical Device manufacturers.
Benefits of compliance and quality solutions for the food services industry
Food quality and food safety are among the most critical concerns of all companies in the food supply chain, especially foodservice operators. Foodservice operators today must strive to meet food quality and safety demands arising from a host of sources including customers. This paper describes how MetricStream's holistic solution for quality management helps companies achieve their quality objectives at the enterprise level.
Enhance quality tracking and process efficiency optimization in pharmaceutical manufacturing
The pharmaceutical industry is among the most heavily regulated, both in the product development,clinical trial and manufacturing phases. The nature of this industry demands the highest standard of production precision and detailed product and process reviews. This paper discusses the advantages of implementing a robust software solution that can address the most complex process and quality requirements in a secure,easy-to-use and scaleable manner for the pharmaceutical companies.
Quality and compliance in the Pharmaceutical industry: issues and perspectives
The pharmaceutical industry is subject to a number of regulations stipulated by Food and Drug Administration (FDA) and other regulatory authorities. These regulations enforce strict quality standards on pharmaceutical companies to ensure the safety and benefits of the products made by them. This paper discusses the importance of IT systems in addressing the issues related to ensuring compliance to FDA regulations.
Quality*Stream for Compliance and Quality Management
Organizations are successfully implementing enterprise-wide quality and compliance systems to gain visibility and control over key quality processes across their operations and to ensure compliance with government regulations, industry mandates, company policies and internal initiatives. This paper discusses how the MetricStream system helps you to comply with industry mandates such as TS16949 or QS9000:2002 or implement internal initiatives such as ISO9000 or sixsigma.
Six Sigma and quality management solutions
Six Sigma is good for business, delivering business results that can accelerate growth, reduce costs and ultimately deliver extraordinary profits to stakeholders. Manufacturing industries, health care and many more sectors have adopted Six Sigma processes to improve performance and deliver customers with unparalleled quality and excellence in products, services and delivery. This paper discusses the Six Sigma methodology and the best practices to implement the same across the enterprise.
TREAD Act requirements for the Automotive Industry
"The TREAD (Transportation Recall Enhancement Accountability Documentation) Act was passed by the NHTSA (National Highway Traffic Safety Administration) in order to generate increased efficiency in data reporting and to create better ties between the field reports and the manufacturing of vehicles and components.This paper discusses the reporting requirements of the TREAD Act."