From PilgrimSoftware.com

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!

General Quality

ISO 9000

Request here!

Automotive Quality

TS 16949

Request here!

Environmental

ISO 14001

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!
Industrial Automation to Quality and Safety Automation — Take the Leap to Lower Risk and Boost Safety in the Food 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.


Request here!

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


Request here!
Document Management (EDMS) This paper addresses how an Electronic Document Management System can help Life Sciences companies increase product and process quality.


Request here!
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. 


Request here!

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.


Request here!

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.



Request here!

Industry Outlook: Cosmetics Manufacturing

This white paper looks at the growing importance of regulatory compliance and continuous improvement within the moderately regulated Cosmetics industry.



Request here!

SmartPulse

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.



Request here!

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!




Complaint Management in the Medical Device Industry: Effectively Handling Complaints
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.
Request here!








Strategies for Managing Liability & Risks Associated with Outsourcing Overseas

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.

 

Request here!









10 Essential Considerations For Selecting the Optimal Clinical Trials Transparency Solution
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.
Request here!








© Copyright by Pilgrim Software