Nonconformance Software Systems – MasterControl

What is Nonconformance Software Systems?

Nonconformance Software Systems aid in the automation and guarantee of adherence to FDA and ISO quality prerequisites, ensuring compliance that is both aligned, interconnected, and comprehensive.

• MasterControl nonconformance software system's purpose
• Designed for ISO and FDA regulated environments
• Automation of paper-based nonconformance processes
• Integration with CAPA processes in company-wide quality system

Why Nonconformance Software Systems?

Nonconformance Software Systems aid in the automation and assurance of adhering to FDA and ISO quality requisites, ensuring compliance that is both aligned, interconnected, and comprehensive.

• Nonconformance Software Systems for Product Materials and Finished Goods

  • Product safety and quality rely heavily on adherence to tested and safe specifications.
  • Effective nonconformance systems are vital for managing products that don't meet standards.
  • FDA regulations and ISO international standards address this issue for drugs, medical devices, biologics, and various consumer goods.
  • Many manufacturers and suppliers follow ISO standards to enhance quality and global competitiveness.
  • ISO 9001:2000 and ISO 14001:2004 are common standards, requiring procedures for handling nonconformance.
  • Adhering to ISO standards is typically voluntary, but some countries and customers demand ISO certification.
  • MasterControl offers this software to ensure compliance with ISO rules for product materials and finished goods.

• Nonconformance Systems for ISO 14000 and EPA Compliance

  • Oil and gas companies benefit from adhering to ISO quality standards (ISO 9000 and ISO 14000) for safe and reliable products/services.
  • Adherence to ISO standards is usually voluntary, though EPA encourages ISO 14000 for better environmental performance.
  • ISO 9001:2000 and ISO 14001:2004 require nonconformance systems for top-quality standards.
  • Nonconformance software systems like MasterControl and MasterControl CAPA support Compliant, Connected, and Complete quality initiatives.
  • They help achieve and sustain compliance with ISO and FDA standards.
  • Optimizing nonconformance disposition process, speeding up initiation to approval, and maintaining readiness for inspections.

• Connected Quality

  • MasterControl quality event management software links nonconformance disposition with other quality processes like CAPA, forming a closed-loop quality approach.
  • It facilitates connections to document management, training, and supplier audits, enhancing the quality management system's efficiency.

• Complete Nonconformance Software

  • MasterControl's capability for enterprise-wide product application
  • Suitable for all departmental forms-based processes
  • Ideal solution for entire organization's needs

• Increased Efficiency Through Automation

  • MasterControl automates tasks related to nonconformance handling, including notification, follow-up, and overdue assignment escalation.
  • Automation streamlines the compliance environment, contributing to easier compliance maintenance.

• Centralized Repository

  • Secure, centralized repository within this software
  • Storage of all nonconformance-related documents
  • Simplified search and retrieval during audits

• Best-Practice Form

  • Simplifies nonconformance process with pre-configured, multi-page form
  • Accelerates evaluation and disposition of nonconforming materials
  • Prompts relevant departments to collect and track data
  • Form automatically routed through this software
  • Escalation if case processing is delayed

• Best-Practice Process

  • Five-step process for quality unit decisions
  • Guides the team from initiation to management approval
  • Ensures timely and appropriate choices
  • Process includes initiation, investigation, recommendation, disposition, and management approval

• Analytics Reporting Tool

  • Nonconformance systems consist of pre-configured reports.
  • End users have the ability to customize these reports.
  • Nonconformances can be analyzed for trends.
  • Incidents can be studied based on various factors such as material, shift, machine, and supplier.
  • The analysis provides insights into systemic quality problems.
  • These capabilities are akin to "data-mining."
  • They offer valuable input for initiating CAPA (Corrective and Preventive Actions).

• Revision Control

  • MasterControl offers automated revision control for document versions.
  • Only the most current document version is accessible.
  • Users making changes in the InfoCard (MasterControl's basic record info tool) must provide a change reason.
  • This software monitors changes to the InfoCard.

• Easy Access

  • MasterControl functions as a cloud-based tool for managing quality events.
  • It fosters connection among employees, suppliers, and stakeholders engaged in nonconformance processes, without location or time constraints.
  • Accessibility supports ongoing collaboration and streamlines audit management.

• Flexible Process

  • MasterControl quality event management software
  • Utilizes best-practice templates for process optimization
  • Customizable to align with existing nonconformance processes
  • Capable of linking with other related processes
  • Manages parallel processes effectively
  • Adaptable to new processes as needed

• Form-to-Form Launching

  • MasterControl simplifies quality event management
  • Enables launching CAPA form from nonconformance form
  • Automatic transfer of relevant nonconformance data to CAPA form
  • Minimizes manual data entry errors
  • Enhances data integrity

• Tracking and Trending

  • MasterControl software preserves links among quality event management processes
  • Enables easy review of completed processes and identification of CAPA triggers
  • Offers strong reporting tools to enhance continuous improvement initiatives
  • Crucial for ensuring long-term success

• Integrates with Other Applications

  • Integration of MasterControl's nonconformance software with various applications
  • Compatibility with ERP, LIMS, accounting, and human resources systems
  • Tailoring to meet specific requirements of different departments

• Easy to Search

  • Nonconformance software includes a standardized search window, similar to Google.
  • The search window is present in integrated applications from MasterControl.
  • Authorized users across the organization can utilize the search window.
  • The search window enables retrieval of change control-related tasks and documents.

• Easy to Find

  • MasterControl's Explorer, resembling Windows Explorer, serves as a user-friendly tool.
  • Users can swiftly locate and access documents using this tool.
  • Each department has the capability to manage its own Explorers.
  • Documents can be stored in various Explorers.
  • System administrators possess control over document management.
  • Automatic document updates are achievable through dynamic links in the InfoCard.

• Automation of Forms-Based Processes

  • Automation of department-specific forms-based processes is possible.
  • This includes forms like HR application forms and customer satisfaction surveys.
  • Preservation of existing form appearance and functionality is an option.
  • Aternatively, departments can design entirely new forms using the nonconformance software.

Nonconformance Software Systems Dealer/Reseller

Factonity Systems Pvt Ltd is a full service dealer & reseller of Nonconformance Software Systems. Apart from software licensing, we also provide authentic software training, local technical support and statistical consulting.

Please contact us for:

• Latest Nonconformance Software Systems pricing information / quotation
• Demo of Nonconformance Software Systems and free initial consultation
• Lean Six Sigma + Nonconformance Software Systems bundled training with licensed of demo software
• Post sales local technical support

Who uses Nonconformance Software Systems?

MasterControl is utilized by numerous global companies to automate essential business processes and manage documents. This adoption fosters collaboration, enhances decision-making, and expedites time-to-market efforts.

Which industries use Nonconformance Software Systems?

Leading corporations utilize Nonconformance Software Systems. Below are a few industries that leverage the capabilities of Nonconformance Software Systems: