Life & Health Sciences - Risk, Compliance and Quality Management Solutions
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Overview
The dynamic Life Science and Healthcare marketplace depends on its ability to rapidly deliver its product or service offerings while simultaneously supporting rigorous FDA and industry requirements. Through its Enterprise Risk, Compliance and Quality Management software, Pilgrim Software helps Medical Device, Pharmaceutical, Biotech, Blood & Tissue Services, Healthcare Service, Laboratories and Treatment Center organizations by automating, streamlining, and effectively managing processes required to develop and maintain safe, high-quality and competitive products and services and improve overall patient care. Pilgrim equips its customers to meet three major challenges. With Pilgrim’s solution you:
Ensure Compliance
Companies face increasing frequency and duration of audits, regulatory warnings, fines, and consent decrees and a proliferation of compliance requirements related to their operational practices, service delivery procedures and records management. Regulatory requirements include FDA 21 CFR Part 11, Parts 606, 820, 210-211, 1270-1271, GMP, GCP, GLP, JCAHO, HIPAA, and other national, state and even international regulations for product and patient safety, and more.
Pilgrim’s solution helps ensure compliance with these regulations, thereby minimizing risk, avoiding the potential for costly recalls, and securing brand reputation. Its pre-built tools enable electronic signatures and automate regulatory recordkeeping, and help your company conduct safety and compliance monitoring by establishing flexible, global workflows for product complaint resolution, nonconformance/deviations, CAPAs and audits.
"SmartSolve will help ensure our ability to meet expected future demand while remaining in full compliance with industry and regulatory requirements by providing a consistent approach that unifies all of our quality and compliance operations in one system.”
Tommy Healy, Director, QA/RA, Vitalograph
Reduce Cost
Homegrown, non-integrated and manual management systems require paper-and labor-intensive processes and result in a lack of data visibility across the organization. Impacts include higher IT administrative and overhead costs, less IT productivity and ineffective resource utilization.
Pilgrim’s solution integrates people, processes, products/services and systems under one automated enterprise solution. This provides for timely data across the company, reduces risk, and reduces the labor requirements by eliminating paper-intensive processes, and lowers administrative and overhead cost.
Improve Efficiencies & Boost Productivity
Life Sciences and Healthcare organizations are pressured to do more with less -- less time and tighter operating budgets. Companies are falling victim to the time and cost of handling documents, identifying and resolving problems in product development and introductions, service delivery, managing supplier quality, maintaining equipment and ensuring a trained workforce and qualified caregivers.
Pilgrim’s solution interfaces with a company’s internal systems (including ERP/MRP, MES, HR, PLM and PDM), to ensure that compliance and quality are part of the entire product lifecycle and service delivery management. The result is streamlined decision making, lowered costs for bringing new products and services to market, the elimination of product stalls and recalls, and the delivery of higher quality product and patient care.
"VitalAire’s vision is based on ‘excellence in safety, quality and regulatory compliance.’ By combining that vision with Pilgrim Software’s capabilities, we are ensuring the highest and most consistent quality approach for all our clients.”
Paul Ostrowski, President & CEO, VitalAire Canada
Resources
Industry Information
Customer Information
Recorded Webinars
- World-Class ECQM Implementation - A Case Study with Millipore
- Understanding Regulations and FDA Enforcement
- KNOCK-OUT NON-COMPLIANCE Workshop
- Drug & Device Off-Label Promotion
- Determining the FMV of Thought Leader Compensation in the Life Sciences Industry
White Papers
The Enterprise Risk, Compliance and Quality Management Platform
Pilgrim Software provides a centralized, enterprise–wide, fully web-based solution for managing adverse event reporting, change control management, complaint handling, corrective and preventive actions, document control and content management, engineering drawing control and collaboration, employee certification and training, equipment maintenance/calibration, internal and external audits, nonconformance management, process management, regulatory submissions, risk management, SOP enforcement, and supplier quality management.
This powerful platform enables you to manage product safety while complying with regulatory requirements; reduce manufacturing and operational costs; increase overall productivity; and, improve customer satisfaction by managing the critical processes that govern your organization.