| Compliance and Quality White Paper Library |
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!
Medical Device Industry - Regulation 21 CFR Part 820
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Medical Device Industry - Regulation ISO 13485
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Biologics Industry - Regulation 21 CFR Part 210-211
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Blood Industry - Regulation 21 CFR Part 606
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Tissue Industry - Regulation 21 CFR Part 1270-1271
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Quality - Regulation ISO 9000
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Quality - Regulation ISO 14001
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Paving the Way to Easy Electronic Medical Device Reporting (eMDR) FDA is urging device manufacturers to voluntarily adopt the agency's electronic Medical Device Reporting (eMDR) process in anticipation of being required to do so in early 2008. The program is intended to help FDA’s Center for Devices and Radiological Health (CDRH) more easily identify patterns in adverse events, as well as to reduce the overwhelming number of paper adverse event reports submitted by manufacturers. Pilgrim has partnered with the FDA since the inception of its pilot program to modernize the data entry process for electronic reporting of adverse events, and has been providing key insights into improving the robustness of the FDA’s eMDR technology. Now, the eMDR Electronic Submission capability is part of Pilgrim’s SmartComplaints™ solution that aids medical device manufacturers with the recording, processing, investigation and resolution of a complaint or Adverse Event.
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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Improving Supply Chain Safety and Reducing Quality Failures in the Food Processing Industry
Supply
chain safety and quality failures reduce overall consumer confidence.
Food processing companies are faced with increasing scrutiny by Senate
Committees, USDA and FDA, and the continuous challenge of maximizing
food safety while adhering to the growing number of regulations. As the
food processing industry has become dependent on extended supply chains
with multiple vendors, risk and quality management has become critical.
The traditional a paper-based approach to a Food Safety and Quality
Management System is still widely used, leading to resource overload,
untimely data and process inefficiencies.
This white paper
addresses the need for the food industry to embrace the same principles
of industrial automation and apply it to 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.
Every time you improve quality, you will always increase the safety of
food.
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Integrated Quality Systems Simplify CAPA Management, Mitigate Risk and Maintain a High Level of Compliance within Life Science Organizations
The consequences of CAPA non-compliance are costly and significant, resulting in damaged brand reputation and, potentially, a company’s long-term profitability. Effective CAPA management is more than just a regulatory requirement – it’s a good business practice. 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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Automated Non-conformance & CAPA Management Cuts Risk in Life Sciences
How are Life Sciences organizations managing quality and compliance today? Like many industries, Life Sciences organizations are using a variety of manual, semi-automated and home-grown systems leading to significant inefficiencies and continued errors which can have severe negative impact on an organization’s productivity and its ability to perform up to its potential.
So how can Life Science companies achieve more efficiency which can lead to operational excellence?
Read this Solution Brief to find out!
Electronic Document Management (EDMS) for the Life Sciences Industry
The majority of document and SOP management problems seen in the Life Sciences industry are related to either outdated data, lack of document control, lack of document or visibility, or inability to track documents as part of an entire quality system. Why is this happening? What can organizations do to overcome those challenges?
And how can an Electronic Document Management System help Life Sciences companies increase product and process quality?
Read this Solution Brief to find out!
Pilgrim Software: Streamlining Compliance and Quality Management Across the Enterprise
Within today’s increasingly competitive global industrial environment, it is imperative that life science companies look at quality as an integral part of their global best practices. Life science companies are being forced to leverage information technology in a significant way to optimize their operational efficiencies and overall quality. The implementation of an enterprise-wide compliance and quality management software solution enables companies to achieve predictable product quality and provides additional inherent benefits.
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. Learn how life science companies can attain the highest quality and create the safest products at the lowest cost to meet customer demand.
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Quality is Lean:
Quality Management is a Fundamental Part of the Lean Enterprise
In manufacturing, “waste” is the sole enemy of lean production – an unyielding roadblock to productivity and customer satisfaction. In the other corner, the ally of “lean” is continuous improvement. Attempting to achieve lean improvements without an effective quality management process in place is a wasted effort. The implementation of an enterprise-wide compliance and quality management (ECQM) software solution enables companies to reduce non-value-added activities, streamline processes and achieve predictable product quality, making an ECQM solution an important part of a lean program.
This white paper reveals the benefits and components of “Lean,” and outlines the various production processes that can effectively be addressed by an automated ECQM solution to remove the “waste” roadblock. Learn 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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Integrated Compliance Management
A sound, cost-effective strategy for exception, change and risk management
Increasing FDA oversight and compliance with cGMP's is forcing companies to take a proactive and automated approach to their enterprise compliance and change management strategies. This white paper will explain the complex challenges to compliance and show how a single, integrated solution can cost-effectively reduce the risk of noncompliance.
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21 CFR Part 11 White Paper
Pilgrim Software's position regarding 21 CFR Part 11 requirements
CFR Part 11 of title 21 of the Code of Federal Regulations: Electronic Records: Electronic Signatures sets forth the requirements for the creation, modification, maintenance, archival, retrieval, and transmittal of electronic records and also the use of electronic signatures. Since these rulings became law in March 1997, the FDA has created several documents with the assistance of industry representatives to offer guidance in interpretation of the requirements. But even with these efforts, the requirements are still somewhat of a moving target.
This document presents the requirements set forth in 21 CFR Part 11, along with Pilgrim Software's own interpretation of the requirements.
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For more information about compliance and quality topics, please take a look at our archived webinars!
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