GxP Best Practices
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The demand for top-quality Life Sciences products is skyrocketing as the world’s population ages and new and expanding health needs emerge almost daily. Consumers are clamoring for the latest and most advanced technology in medical devices, pharmaceutical and biologics products, and even blood and tissue banking.
While the demand is good news for the bottom line, businesses within these FDA-regulated industries must think of more than just making a profit. Today, companies within the life sciences industry must follow best practices (GxP) guidelines to ensure that the entire manufacturing process, across all phases of clinical trials, technology transfers/scale ups, manufacturing and post-market surveillance, meet requirements of compliance and quality.
Pilgrim Software provides an enterprise-wide compliance and quality management solution that supports Life Sciences companies in meeting and sustaining Part 11 requirements and GxP (GCP, GLP and/or GMP) standards. By improving operational efficiencies in quality systems and regulatory compliance, Pilgrim helps organizations proactively identify, track and resolve issues, while reducing related costs, giving those companies a competitive edge in today’s competitive consumer environment.
1. Ensure Regulatory Compliance
As offerings from Life Sciences manufacturers expand globally, companies face increasing frequency of inspections, regulatory warnings, complaints and product recalls. The span of regulatory requirements includes 21 CFR Part 11 requirements and GxP standards, as well as those set by ISO, GAMP, QSR, FDA/CBER (blood regulations), OSHA and HIPAA.
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, risk and compliance monitoring by establishing flexible, global workflows for product complaint resolution, nonconformances, CAPAs and audits.
2. 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 enterprise. The impacts of an inefficient, un-unified and un-enforced system include higher IT administrative and overhead costs, less IT productivity and ineffective resource utilization.
Pilgrim’s solution allows organizations to meet key GxP requirements by integrating people, processes, products and systems under one automated enterprise solution. This provides for timely data across the enterprise, reduces risk and reduces the labor requirements by eliminating paper-intensive processes, and lowers administrative and overhead cost. Pilgrim also offers corresponding validation packs that allow companies to ensure the integrity of electronic records and signatures as required by 21 CFR Part 11. This eliminates the need for internal staff to conduct labor-intensive validation tests or to pay exorbitant consultant fees that can easily double the cost of compliance.
3. Reduce Cycle Time, Improve Efficiencies & Boost Productivity
Companies with multiple facilities often look to keep costs down by operating disparate, paper-based or hybrid GxP systems. Long term, however, these inefficient systems require employees to devote an overwhelming amount of time to tasks that could be streamlined by an automated system, such as: routing SOPs and other documentation; obtaining approval and signatures; face-to-face meetings to discuss changes; and manual search and retrieval of documents during FDA inspections. Disparate, disconnected systems for customer complaints, CAPA, training and audit management also can lead to costly delays and poor results.
Added Support
Pilgrim Software provides valuable Professional Services to help ensure that your quality and compliance program is a complete success. Pilgrim’s expert staff of consultants provides everything from project management to system customization to validation, and helps you minimize your risk and maximize your return on investment.
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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.
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