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Resources
Compliance and Quality White Paper Library
By
Oct 25, 2005, 16:04

Pilgrim Software is pleased to offer the following white papers for your educational and research needs.


Regulatory White Paper Series

For manufacturers in today’s increasingly regulated Life Science industry, understanding industry regulations and knowing how best to adhere to them is now standard.

As a business enterprise with concern for both the bottom line and patient safety, it’s reassuring to manufacturers to know that meeting standard compliance needs does not have to be a costly process. 

These Industry Regulation White Papers provide a concise look at those specific subparts of each regulation that can be supported through cost-effective automation to ensure a manufacturer’s compliance.  Request one or all of our NEW Industry Regulation White Papers now!

Industry Regulation Link
General FDA-Regulated 21 CFR Part 11

Request here!

Medical Device 21 CFR Part 820 Request here!

ISO 13485  Request here!

Correspondence -
ISO 13485:2003 &
QSR Part 820
Request here!
Biologics  21 CFR Part 210-211 Request here!
Blood 21 CFR Part 606 Request here!
Tissue 21 CFR Part 1270-1271
Request here!
Quality ISO 9000 Request here!

ISO14001 Request here!

 

Pilgrim White Papers

Title Description Link
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.

 

Request here!

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.


Request here!
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.
 

Request here!
Supply Chain Safety  in the Food Processing Industry

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.


Request here!

CAPA Management

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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CAPA Management This paper reveals how Life Science companies can achieve increased operational efficiency through automation, leading to operational excellence.


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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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ECQM

This white paper reveals the benefits of a fully integrated ECQM solution for top-down regulatory compliance , including minimized business risks, optimized costs, and reduced time to product launch. 


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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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ICM for Exception, Change and Risk Management

This white paper will explain the complex challenges to compliance and change management strategies, and show how a single, integrated solution can cost-effectively reduce the risk of noncompliance.



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Other Industry White Papers



Title Description Link
2008 Survey Results on Achieving and Maintaining CAPA Compliance
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.
Request here!



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.
Request here!




Risk Management: Best Practices for Medical Device Profitability
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.
Request here!




For more information about compliance and quality topics, please take a look at our archived webinars.







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