For organizations looking for a complete solution for regulatory compliance, risk management and operational excellence, Pilgrim Software is the answer. Pilgrim supports these organizations to turn compliance into profits and strategic advantage.

Established in 1993, Pilgrim Software is growth-oriented and the most experienced provider of Enterprise Risk, Compliance and Quality Management software. Pilgrim has been dedicated to meeting the diverse compliance challenges faced by regulated and highly competitive industries. Organizations from these industries require a software partner with the product vision, leadership and viability to help them achieve long-term overall compliance and continuous improvement goals. Regulated companies do not have to see compliance as a hindrance anymore.

Enterprise Risk Management White Paper	Supply Chain Quality White Paper

Pilgrim Software's fully Web-based solutions help Pharmaceutical and Biotech organizations ensure product safety and enterprise-wide compliance with regulatory requirements, organizational SOPs and industry best practices. Built on nearly two decades of domain expertise Pilgrim's risk, compliance and quality platform offers the following powerful, fully integrated solutions:

• Adverse Event Reporting
• Change Management
• Corrective and Preventive Actions (CAPA)
• Customer Complaints
• Document and Content Management
• Employee Training and Certification
• Application Design/Workflow Process Management
• Equipment Management
• Internal and External Audit Management
• Inspection Management
• Nonconformance/Event Management
• Regulatory Submissions
• Risk Management
• Record Management
• Supplier Quality

Pilgrim's risk, compliance, and quality management software solutions can also help your organization comply with today's standards for Good Business Practices such as ISO and its related standards, GMP, GCP, GLP, GAMP, SQF, etc., by helping to clarify and monitor increasingly complex industry regulations. Through implementation of Pilgrim's integrated management software, you can:

• Manage Overall Compliance (FDA, EMEA, SOX, OSHA, etc.)
• Improve Quality (GxP, ISO, etc.)
• Mitigate Risk
• Increase Productivity
• Reduce Costs
• Drive Continuous Improvement

21 CFR Part 11 Standards

Pilgrim Software offers the following white papers on various 21 CFR Part 11 standards and how to address their complexities:

• 21 CFR Part 210-211
• 21 CFR Part 1270-1271
• 21 CFR Part 606
• Pilgrim Software's Position Regarding 21 CFR Part 11 Requirements

Webinars

CAPA & Clinical Trials
Description: CAPA programs that employ Root Cause Analysis are key to providing quality practices within the clinical research process. A solid CAPA system will not only identify problem trends, but help drive the highest quality of research. Learn how through this free webinar.

Enterprise-wide Audit Management
This webinar spotlights ease of access to audit data for management, auditors, and auditees, and discusses how audit management fits into Pilgrim's Integrated Compliance Management platform.

Training Management Product Showcase
This webinar will spotlight integration with Pilgrim's Document Management capabilities to ensure employee knowledge of newly released, refresher or revised SOPs and other relevant documentation. Further highlights will include simple access to training reports concerning both past and current employee training history using Pilgrim's e-mail notifications, dashboards and automated reporting tools.

Good Governance for Supply Chain Vendor Compliance
As a result of the growing complexity and awareness of the global supply chain management process, companies need to sit up and pay attention to their supplier quality programs. Through this engaging webinar session, you will hear how global organizations can efficiently and effectively manage their value-chain processes as global regulatory oversight continues to expand.

Accept Reality and Take Control: Manage Change Across Your Enterprise
Managing change can pose a serious challenge due to insufficient support systems for helping organizations make informed decisions and quickly implement such changes. Change Management software can not only help you solve problems today and help you detect problems in the future, but can be a powerful tool for performance monitoring and continuous improvement in the organization.

ISO 9001:2008 - Evolving Your Compliance, Quality and Risk Systems into the Global Workplace
The following topics will address how companies can look at their internal systems to determine if they can improve based on where they are in their evolutionary phase:

• Advanced Quality Planning feeds Quality Systems and Corrective and Preventive Action (CAPA) Systems positive feedback into all phases of product life-cycle
• Integrating your Quality and Compliance Systems with mission-critical systems
• Visualization of global data/measurements
• Managing global audits.

Laboratory Accreditation: What Does Accreditation Mean to the Calibration or Testing Customer
During this webinar, Mr. Payne will present an overview of the ISO/IEC 17025 laboratory accreditation standard for calibration and testing laboratories, including:

• Why laboratory accreditation is important in the overall scheme of global trade
• What accreditation means to calibration and testing laboratories
• What benefits it gives to the customer of a calibration or testing laboratory
• How to determine the adequacy of the accreditation for your needs

A Webinar Series: Risk Management
An increasing number of regulatory mandates and more active involvement among shareholders are prompting organizations to focus their efforts more closely than ever on identifying areas of potential risk across their enterprise. By implementing an integrated Risk Management system enterprise-wide, organizations can reduce the potential inefficiencies that result from unanticipated operational disruptions and evolving regulations and restrictions. These webinars demonstrate how effective Risk Management ultimately promotes healthy operating margins, process efficiencies, quality and compliance, and overall profitability.

A Webinar Series: Quality in the Global Supply Chain
Supply chain complexity has grown from simple domestic sourcing, manufacturing and distribution, to a complex evolution of global sourcing, manufacturing and distribution centers around the world. Consequently, an increasing number of regulations are being handed down by the FDA, EMA and other regulatory bodies, with emphasis on outsourcing and suppliers, document retention down the supply chain tiers, and industry guidelines concerning the control of outsourced processes.