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Contract Manufacturing (CMO) - Risk, Compliance and Quality Management Solutions

Overview



Contract Manufacturing seems to offer enterprises the best of all worlds.  By outsourcing their manufacturing operations, global organizations are able to focus more on their core competencies, value propositions, and engineering. And contract manufacturers provide other advantages over internal manufacturing: lower costs, flexibility, access to external expertise and reduced capital expenditures. But with these advantages, come additional potential drawbacks. Companies must use caution to ensure their outsourced operations are well managed – compliant and up to quality standards.  Likewise, the contract organizations face challenges, both their own operational challenges and the constant quest to satisfy their customers.

Pilgrim Software helps contract manufacturing organizations meet, or exceed, their customers’ expectations by automating, streamlining, and effectively managing processes required to develop and maintain safe, high-quality and competitive products for those customers. Pilgrim equips its Contract Manufacturing customers to meet major challenges. With Pilgrim’s solution you:


Ensure Compliance
Like the companies they supply, contract manufacturers must meet certain quality and compliance requirements, including ISO (ISO 9001, ISO 14001 and ISO/IEC 18000) and OSHA guidelines, and even customer-specific quality requirements. This directly impacts companies’ revenue growth and market expansion.

Pilgrim’s solution helps manage risk, identify and resolve customer problems, document SOPs and best practices, support change control, identify and resolve non-conformances, calibrate equipment, and audit the company’s state of quality and compliance. The results are improved customer satisfaction and brand reputation, and reduced cost of poor quality.  Cost savings then can be passed on to the customer, boosting support for the contract relationship.


Improve Efficiencies and Accelerate Production
The global race is on to produce increasingly complex products under the textbook principles of “lean manufacturing.”  For contract manufacturers, this means improving supply chain management, process cycle management, and product release management. This is driving contract producers' need to implement standardized processes within their organizations

Pilgrim’s solution, built on best practices from ISO and GMP standards, provides closed-loop change management, corrective and preventive action, trending and analysis of cycle times and costs, facilitating root cause analysis and ultimately improving efficiencies and boosting production.  For the customer, this means the contract manufacturer eliminates the customer’s capital investment in potentially underutilized production capacity; eliminates long lead-time to build and validate a cGMP manufacturing facility; and avoiding the development and scale-up phases in a cGMP environment.


Capitalize on Quality and Customer Satisfaction
Poor, or poorly-perceived quality can result in high costs associated with warranty issues, recalls, litigation, and negative marketplace perception. Compliance with quality standards in your products is critical to successfully exceeding your customers’ expectations.

Pilgrim’s solution supports manufacturers by helping to ensure the quality and safety of their products, and to secure the trust of their customers.  Risk management, supplier and internal audits, and calibration software are essential quality solutions for the entire product lifecycle and drive customer satisfaction to new levels.

 

 

The Enterprise Risk, Compliance and Quality Management Platform
Pilgrim Software provides a centralized, enterprise–wide, fully web-based solution for managing adverse event reportingchange control managementcomplaint handlingcorrective and preventive actions, document control and content managementengineering drawing control and collaboration, employee certification and training, equipment maintenance/calibration, internal and external audits, nonconformance management, process management, regulatory submissionsrisk 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.