Deviation Management Software – MasterControl

What is Deviation Management Software?

Optimizing Deviation Handling to Enhance Product Quality and Conformance. MasterControl's software designed for managing deviations offers an efficient method for investigating and resolving product deviations, leading to elevated quality standards and a more straightforward approach to meeting regulatory requirements. When products under regulation do not align with specified criteria, documenting the deviation's causes and conducting a comprehensive inquiry are of utmost importance.

• MasterControl's Deviations™ solution streamlines deviation management
• Efficiently documents, investigates, and resolves deviations
• Ensures compliance with regulatory requirements
• Product quality maintenance is vital in regulated industries
• Deviations from approved processes can compromise quality
• MasterControl's software expedites deviation identification and resolution
• Facilitates prompt corrective actions
• Reduces impact on product quality
• Automates deviation management processes
• Eliminates manual paperwork
• Centralized platform for capturing and analyzing deviation data
• Enables efficient collaboration
• Aligns with regulatory authorities (EU GMP, U.S. FDA)
• Strengthens quality management processes
• Streamlines compliance efforts

Why Deviation Management Software?

The perfect approach to managing and preventing the repetition of discrepancies.

• Optimized Deviations Management

  • Peace of Mind: Achieved through effective control and proactive mitigation of quality risks.
  • MasterControl's Track Record: Proven success in assisting manufacturers with deviations management.
  • Deviation Control: Transformed into a tool for continuous quality improvement by MasterControl.
  • Quality Improvement: Facilitated through MasterControl's assistance in managing deviations.
  • Manufacturer Support: MasterControl aids in achieving deviations management success..

• Best-Practice Forms and Processes

  • MasterControl includes preconfigured forms that assist users in gathering deviations information.
  • The forms are designed with multiple pages and guide users to collect and manage relevant data for making informed decisions.
  • Completed forms are automatically directed to the relevant decision-makers within the system.
  • In case of delays, the system can be configured to escalate unresolved forms for prompt attention.

• Streamlined Regulatory Compliance

  • MasterControl deviations management systems prioritize quality compliance.
  • The system ensures compliance with regulations like 21 CFR Part 11 and 21 CFR Part 820.
  • It offers secure and time-stamped audit trails.
  • Full reporting and electronic signature capabilities are provided.
  • MasterControl surpasses the requirements of ISO 9000 and ISO 13485 standards.

• Integrated Quality Processes With Enhanced Reporting

  • MasterControl automates information transfer into forms for various quality processes (e.g., nonconformances).
  • It enables direct launching of forms from deviations, minimizing data entry mistakes.
  • Users can analyze and track deviations by different factors like process, product, and vendor.
  • The system's analytics uncover systemic quality problems, providing valuable insights.

• Connect Quality Data With Integrated Quality Event Software

  • MasterControl integration of deviations with quality event management processes
  • Centralization of current deviation data within the system
  • Linkage of deviations to associated concerns, such as variant management
  • Cross-functional capability for departments to address issues proactively
  • Prevention of escalation that could lead to operational delays or disruptions

• Accelerate Deviation Turnaround Times

  • MasterControl automates data collection, routing, follow-up, and escalation tasks.
  • The system is specifically designed to ensure compliance.
  • It features an advanced deviation tracking system for active deviations.
  • This aids in staying current and promptly resolving issues.

Deviation Management Software Dealer/Reseller

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

Please contact us for:

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

Who uses Deviation Management Software?

Numerous companies around the globe employ MasterControl to enhance efficiency and expedite the product launch process. Discover the advantages of automating tasks like deviation management and variant control, among others.

Which industries use Deviation Management Software?

Leading corporations utilize this software. Below are a few industries that leverage the capabilities of this software: