Regulatory Compliance Management Software Systems

Regulatory Compliance Management Software Systems Streamline Compliance Operations and Simplify Quality Processes

For most organizations subject to industry defined regulatory requirements, regulatory compliance management software systems are irreplaceable tools for managing internal or external regulatory inspections of quality processes. Regulatory compliance software designed for such assessments enable companies to efficiently ascertain outstanding actions that may be required and allow them to quickly act on issues in order to properly identify and respond to all aspects of a regulatory authority's inspection focus.

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Benefits of Regulatory Compliance Management Software Systems

There are two main purposes of regulatory compliance management software: to control the flow of quality information and to effectively manage compliance documentation. In highly regulated environments (such as those of life science and general manufacturing industries) a proven and comprehensive software system must be able to meet local and/or global regulatory compliance requirements and also allow users to:

  • Electronically manage quality activities
  • Handle process-based inspections and audits
  • Maintain status information on suppliers/vendors/third parties
  • Support qualified personnel with expanding review responsibilities
  • Meet the challenges of GLP multi-site study requirements
  • Manage clinical trial site information including IRBs
  • Provide electronic GLP master schedules
  • Perform batch releases
  • Issue QA statements and audit certificates

When a regulatory compliance management system is deployed, it should make it possible for the organization to easily develop detailed inspection plans that can be readily shared with the appropriate authorized parties. An effective system should also be flexible in its programmability and allow for electronic prompt updates to remind users of planned, current, and outstanding activities. Another beneficial feature may include a scoring system that helps quality auditors assign ratings based on assessments of the criticality, frequency, and impact of a finding.

MasterControl's Regulatory Compliance Management Software Systems

The regulatory compliance management software system available from MasterControl includes all of the aforementioned features relating to quality inspections, plus it provides users with ability to:

  • Directly enter and categorize findings
  • Attach supporting evidence as applicable
  • Perform peer reviews
  • Approve reports prior to issue
  • Issue into a secure web browser or document for direct entry of responses and actions
  • Analyze root causes
  • Perform risk assessments
  • Enter auditor-specific notes

Bonus Features of MasterControl's Regulatory Compliance Management Software System

  • Proven Solution Designed for Regulatory Environments: MasterControl is a worldwide leading provider of regulatory compliance management software systems for quality teams in highly regulated industries. More than half of the world's top 20 pharmaceutical companies' R&D groups, for example, depend on MasterControl's systems to meet their quality management needs.
  • Comprehensive, Integrated System: MasterControl's software unites all quality programs into a single all-inclusive system, which means all support and oversight efforts can be shared equally across the enterprise. The system provides maximum flexibility without any need for vendor intervention, external consultants, or additional costly programming. The solution includes all the necessary tools within the standard product, right off the shelf. Customers can decide which features are most beneficial for their particular purposes without being required to purchase costly add-on options that may not be needed.
  • A Cost Effective Solution: MasterControl is intuitive and reduces training time, which immediately results in a positive return on investment at a remarkably low total cost of ownership. The MasterControl regulatory compliance management softwares scheduling and planning tools also help to maximize resource usage.
  • Sustained Compliance: The interconnected MasterControl software is based on a flexible access security model and provides essential compliance-oriented features such as audit trails and electronic signatures. The system is also fully compliant with U.S. 21 CFR Part 11. Specific functionality related to GLP, GCP, and GMP is included with the standard off-the-shelf product.
  • Flexibility: At its core MasterControl's regulatory compliance management software system contains built-in flexible business processes and also incorporates predefined workflows that customers can implement as is or customize to formulate a completely unique workflow. This cost-reducing malleability allows users to easily update the system to conform to internal procedures without requiring any assistance from outside consultants or other third parties.
  • Electronic Tracking and Distribution Activities: Since it is a completely paperless solution, MasterControl makes ideal use of fully electronic activity recording and distribution features, including response receipts and automated CAPA tracking.
  • Powerful Reporting Tools: MasterControl regulatory compliance management software comes complete with robust data trending, metrics, and compliance surveillance tools that allow users to observe quality and compliance statuses. The software incorporates trending/metrics data, risk assessment, and root cause analysis tools to enhance the overall effectiveness of quality and compliance supervision.
  • Language Translation Tools: The MasterControl regulatory compliance management system's language capabilities are useful for translating dictionary data and displaying system field labels in the user's local language. Global deployment is also simplified by the solution's multiple language capabilities, which include single - and multi-byte characters.
  • Reduced Implementation Time: Business processes are pre-mapped in the standard out-of-the-box system, which minimizes the time needed to implement the software.

The Value of a Web-based Regulatory Compliance Management Software System

MasterControl's regulatory compliance management software system gives companies the freedom of automated quality processes and allows them to replace inefficient, outdated paper-based systems with a high powered electronic solution. MasterControl allows users to:

  • Create quality and compliance plans
  • Effectively manage resources and projects
  • Write quality and compliance findings directly into a central database
  • Perform peer review/approval prior to issuing reports
  • Electronically issue results to a document or web browser
  • Remotely record findings

The MasterControl regulatory compliance management software system's web-based response features allow personnel to electronically receive findings and comments, appropriately respond to them in a timely manner, and track the status of individual CAPAs. Workflows can be configured to manage follow-up and implementation status and email reminders can be automatically generated as deadlines approach.

MasterControl's multiple standard reports - as well as an ad-hoc query tool - provide users with compliance trends, metric analyses, and CAPA status reports, as well as the statuses of studies, projects, and activities. Security features, audit trails, and adherence to U.S. 21 CFR Part 11 guidelines are all standard components of MasterControl's software.

Contact MasterControl Today for More Information on Regulatory Compliance Management Software Systems

For more information on MasterControl's regulatory compliance management software systems Contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.