MasterControl Variance™ - Variance Process and Documentation Software


Software System to Automate Variance Processes

One of the main goals of quality is to avoid deficient parts entering into production and prevent deficient products from being shipped from your facility. Under very specific circumstances, exception from the written specification can be made after appropriate reviews by the quality and engineering departments. MasterControl Variance effectively manages this process and documents the scrutiny applied to these types of decisions.

Download Free Resources
Product Data Sheet: MasterControl Variance™
Product Data Sheet: MasterControl Process™
Product Data Sheet: MasterControl Business Process Library™
White Paper: Reducing the Documentation Burden in FDA Design Control
White Paper: Cost of Inaction - Taking Quality Management Processes Digital
Webinar: Simplifying Batch Record Documentation in Preparation for MES/EBR
Webinar: Automating and Integrating Employee Training Processes to Ensure Compliance


How Can MasterControl Variance Software Help You?

MasterControl Variance, part of the integrated MasterControl document and GxP process management suite, provides out-of-the-box functionality for variance management. The MasterControl Variance software solution offers a formal mechanism for evaluating whether or not a material that fails its quality attribute specification should be accepted. The MasterControl system automatically routes requests to appropriate internal personnel to make a final decision. The rationale for decisions on variances are recorded and retained in MasterControl’s secure, centralized repository, which creates a permanent record and supports future audits and/or investigations.

Here’s how MasterControl addresses some of the major challenges companies face when dealing with variance issues:




 

Challenges MasterControl Solution



Inconsistent System:

Written specifications define the quality attributes components and final product has to meet to be acceptable. In the rare cases where product is acceptable despite a failure against the spec, it can be difficult to create a permanent record that shows the decision process.


Consistent System:
MasterControl Variance defines a consistent process for approving a variance against specifications. A permanent repository makes records available at the click of a button and electronic signatures ensure accountability of actions taken.



Unsafe System:

Without formal variance processes and a secure system to store variance information, costly errors that may lead to unsafe products or recalls are likely to occur.

Secure System:

MasterControl not only provides an automated, formalized variance process but also guarantees that variance documentation is maintained in a secure and central repository.




Disconnected Processes:

Manual systems can’t connect forms-based processes such as variances. Such systems make continuous improvement almost impossible. Ensuring the sufficiency of documentation becomes error-prone and time consuming.

Connected Processes:
MasterControl integrates quality processes for a more effective and efficient quality management. The automated system ensures the accuracy of documentation and permanence of process records.






Features and Benefits of MasterControl Variance

  • Variance Initiation and Review: MasterControl ensures that only designated users have privileges to initiate variances. Reviewers, such as QA and production personnel, are also restricted based on system designations. Designated users and reviewers can be added or removed from these groups at any time and the system will automatically adjust to the changes.
  • Input on Product Impact: The MasterControl system routes variances to technical experts in research and manufacturing groups to assess the impact of a variance on the quality of the product. Quality Assurance makes the final decision on the disposition of the variance.
  • Reporting Capabilities: Using MasterControl’s fully customizable reporting capabilities, incident report queues can be continually monitored and the occurrence of incidents analyzed. The system comes complete with the following pre-configured reports: Active Variance, Variances by Product, Variances by Specification, Variances by Category, Variances by Disposition.
  • Part 11-Compliant Features: MasterControl provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy the FDA’s 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.
  • Unparalleled Validation Features: To better meet the needs of companies in regulatory environments, the MasterControl validation approach dramatically cuts the time, pain, and cost involved in validation. MasterControl's continuum of innovative validation products and services include MasterControl Transfer OQ™.
  • Product Training: MasterControl’s Professional Services team has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster. The team conducts training at MasterControl’s state-of-the-art Education Center in Salt Lake City and also at customers’ facilities.
  • Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer’s needs, from initial installation to regular maintenance.

About MasterControl

MasterControl Inc. produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company’s critical information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit www.mastercontrol.com, or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); or 03-6801-6147 (Japan).