| Title |
Description |
| Audit |
This white paper examines the topic of today's increasing regulatory requirements and the pressure they place on manufacturers; describes some of those regulations; looks at their implications and subsequent challenges; and, reveals how Pilgrim’s SmartAudit effectively supports corporate compliance at the enterprise level.
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| ECQM |
This white paper discusses Pilgrim Software’s selection by Frost & Sullivan in both 2007 and 2008 as “North American Enterprise Compliance & Quality Management Company of the Year,” and the inherent benefits associated with the implementation of an enterprise-wide compliance and quality management system for Life Science companies.
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| eMDR |
This white paper will guide you in your understanding of the new eMDR process and what you need to do to make the move to electronic submissions. Discover how an electronic reporting system will allow you to streamline your processes while cutting costs and maintaining compliance.
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Industrial Automation to Quality and Safety Automation — Take the Leap to Lower Risk and Boost Safety in the Food Industry
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This white paper addresses the need for the food industry to apply best practices in quality and safety management automation and think of the system as a whole - a global program, trained employees, well-documented SOPs and utilizing technology properly to put global practices and procedures in place.
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CAPA Management Whitepaper |
This paper addresses an integrated quality systems approach for CAPA Management, helping to mitigate risk and maintain a high level of compliance.
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Automated Nonconformance & CAPA Management in the Life Sciences Industry Whitepaper |
Discover in this white paper how rapid implementation of an enterprise-wide CAPA solution will save your company time and money, and lead to improved product quality and higher customer satisfaction.
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SOP - Implementing An Effective Corrective and Preventive Action (CAPA) System Whitepaper |
By: enKap
The purpose of this SOP Whitepaper is to define general and specific requirements for the identification, initiation, management, control, monitoring, closure and oversight for the Corrective And Preventive Action (CAPA) system.
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Document Control Automation Whitepaper
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This white paper addresses Document Control Automation for a Cost-Effective Enterprise-wide Management & Compliance system.
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Electronic Document Management (EDMS) |
This paper addresses how an Electronic Document Management System can help Life Sciences companies increase product and process quality.
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| Lean Quality |
This white paper reveals how manufacturing companies can establish a collaborative environment among multiple sites, multiple organizations, customers and suppliers, through a quality platform that supports truly lean production.
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Industry Outlook: Cosmetics Manufacturing
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This white paper looks at the growing importance of regulatory compliance and continuous improvement within the moderately regulated Cosmetics industry.
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SmartPulse
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This white paper examines the short- and long-term benefits of using Business Intelligence (BI) tools, such as Pilgrim Software’s SmartPulse solution, to keep a pulse point on corporate quality and compliance KPIs.
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Other Industry White Papers
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| Title |
Description |
Why Pharmaceutical Supplier Quality Management presents special challenges for Risk Management
|
By: Mark Frankcom, Adjunct Professor of Risk Management, Virginia Tech University
Read about the unique challenges of supplier quality risk management in the Pharmaceutical industry, and how to undertake a risk management process that covers the entire supply chain.
Request here!
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2008 Survey Results on Achieving and Maintaining CAPA Compliance
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By: Compliance-Alliance
CAPA management is integral to process control efforts among medical device companies. This paper presents the results of a survey on Achieving and Maintaining CAPA Compliance, revealing the practices firms are using in their corrective and preventive action systems.
Request here!
|
Top Ten Reasons
to Automate
Manufacturing
Compliance |
By: Cincom Manufacturing
Business Solutions
The ability to produce consistently high-quality products is the key to accomplishing revenue and profit goals, and compliance to standards is the ultimate competitive weapon. This paper outlines the top 10 reasons manufacturers need to consider automating their compliance initiatives and strategies.
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The High
Costs of Non-Compliance for Manufacturers |
By: Cincom Manufacturing
Business Solutions
The EU’s Reduction of Hazardous Substances (RoHS) and Waste Electrical and Electronic Equipment (WEEE) have become forefont issues in global manufacturing. This paper discusses the competitive advantages of integrating compliance with these regulations within the supply chain.
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Risk Management: Best Practices for Medical Device Profitability
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By: Cambashi Inc.
In Conjunction with FDAnews
The purpose of this research was to assess the extent to which risk management is routinely employed within medical device companies as part of day-to-day development, procurement and manufacturing operations. It also identifies weaknesses in current approaches and identify best practices.
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Complaint Management in the Medical Device Industry: Effectively Handling Complaints
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By: Compliance-Alliance
The medical device industry is one of manufacturing’s most closely regulated industries. Complaints handling is one of the industry’s key regulatory issues. This paper presents the results of a survey on how companies are managing their complaints handling processes to help reduce noncompliance risks.
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Strategies for Managing Liability & Risks Associated with Outsourcing Overseas
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By: Savage & Dopson, Sedgwick, Detert, Moran & Arnold LLP
Rising costs are forcing many manufacturers to look in new production locations for cheaper labor and materials. As companies grow more dependent on 3rd-party vendors, they also become exposed to new quality control issues & liabilities and ultimately be liable for their foreign vendors' actions – a product can be outsourced, but the risk associated with it can't.
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10 Essential Considerations For Selecting the Optimal Clinical Trials Transparency Solution
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By: Virtify, Inc.
This white paper addresses how to distinguish between various product and service offerings for clinical trial disclosure, and best practices for improving the compliance process to satisfy current complex global transparency requirements and prepare for future regulatory directives.
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