Clinical Laboratories - Risk, Compliance and Quality Management Solutions
| 
Overview
Clinical laboratory testing plays a crucial role in the detection, diagnosis and treatment of disease in patients. Across the world, laboratory tests help determine the presence, extent, or absence of disease and monitor the effectiveness of treatment. An estimated 60-70 percent of all decisions regarding a patient's diagnosis and treatment, hospital admission and discharge are based on laboratory test results.
As such, labs need to sustain a commitment to quality and demonstrate a certifiable level of compliance. Guidelines for quality planning can be found in government regulations, accreditation standards, and national practice standards such as CLIA, JCAHO IOP, NCCLS QC, ISO 15189:2007, ISO/IEC 17025, along with detailed guidelines from CAP (College of American Pathologists) and COLA (Commission of Office Laboratory Accreditation). In addition, 21 CFR Part 58, or Good Laboratory practices (GLP), and key elements of 42 CFR 493 (CLIA) are needed as part of a good Clinical Laboratory best practices (cGCLP). And labs need to keep current with changes to these regulatory requirements and/or the addition of new regulations.
Established and emerging labs are equally faced by other key industry, quality, and safety challenges, including:
- Meeting or squeezing timelines and driving down costs
- Ensuring the quality, accuracy, and integrity of test results and other laboratory data
- Continuous training of laboratory workers
- Establishing and maintaining effectiveness metrics
- Timely management of risks and CAPAs
As a result, an increasing number of clinical and medical laboratory organizations are seeking solutions that enable them to sustain compliance and ensure ongoing viability and performance. Automated enterprise compliance and quality management software does just that. It addresses a laboratory organization's needs, by allowing management to view compliance in a comprehensive and integrated manner.
Pilgrim Software offers a fully integrated compliance and quality solution for clinical and medical laboratories that helps ensure these organizations meet the necessary regulatory requirements and quality standards, while driving efficiencies upward and costs down. Pilgrim equips its customers to meet key challenges. With Pilgrim’s solution you:
Ensure Regulatory Compliance
Medical and clinical laboratories face an increasing frequency of inspections, regulatory warnings, and product efficacy testing. Determining key quality indicators, meeting regulatory requirements and monitoring (quality audits) are a key necessity to ensure the highest quality delivery of services.
Pilgrim’s solution helps ensure compliance with the various industry regulations, thereby minimizing risk and securing reputation. Its pre-built tools enable electronic signatures and automate regulatory recordkeeping, and help labs conduct safety, risk and compliance monitoring by establishing flexible workflows for product complaint resolution, nonconformances, CAPAs and audits.
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 laboratory operation. Impacts include inconsistent auditing of GLP processes, higher IT administrative and overhead costs, less IT productivity and ineffective resource utilization. Further, labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost.
Pilgrim’s solution integrates 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.
Improve Efficiencies & Boost Productivity
Laboratory organization are faced with risk issues and internal and external audit concerns And they are pressured to do more of this with less -- less time and tighter operating budgets. Labs are falling victim to the time and cost of handling documents, change management, identifying and resolving complaints, managing supplier quality, maintaining equipment and ensuring a trained workforce.
Pilgrim’s solution interfaces with an organization’s internal systems to ensure that compliance and quality are part of the entire operational lifecycle management. The result is streamlined decision making, reduced operating costs, and an increased assurance of quality and compliance.
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.