Quality Consulting Services

Quality Consulting Services

MasterControl's Quality Consulting Services Help Regulated Companies Make Sense of Global Compliance

MasterControl's consultative arm, the MasterControl Quality and Compliance Consulting Team, offers quality consulting services and on-site quality management workshops for users of MasterControl software and non-users alike on core quality processes (CAPA, audit management, risk management, supplier management, and document management) to help regulated companies not only comply with international regulatory standards, but also gain a competitive edge in the marketplace.

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The workshops, which are based on industry best practices, and are not software specific, are delivered at the customer's facility and can be customized to focus on GxP, ISO, or other compliance considerations. The quality consulting services are ideal for any company that needs hands-on help identifying the strengths and weaknesses in its quality management system (QMS), or developing a system from scratch if one is not in place. Quality coaches are available to work on-site to guide a quality team throughout the QMS implementation process.

Quality Consulting Services Delivered by QMS Experts with Real-World Experience

Why choose MasterControl quality consulting services? Members of the MasterControl Quality and Compliance Consulting Team possess a thorough understanding of ISO standards, as well as FDA and other global regulations. Composed of QMS lead auditors and quality experts, our consultants are often invited to share their expertise at industry conferences and events and are actively involved in associations and boards for professionals in regulated industries. The Team's track record in delivering quality consulting services that help both large and small organizations understand and overcome today's most complex compliance and regulatory challenges is unmatched.

A Comprehensive Offering of Quality Consulting Services

The MasterControl Quality and Compliance Consulting Team is well positioned to provide a full suite of quality consulting services, and can provide assistance regardless of the QMS solution used by a company, or even when the company does not have a quality system in place. Whether an organization is looking for limited training on a specific quality process, such as supplier management or CAPA event management, or it is in need of more extensive support, the Team offers a wide range of quality consulting services and assessments to meet all quality management initiatives including:

  • Gap analysis of all quality processes and deficiencies
  • Standards and pre-assessment of a QMS to regulation or guidance
  • Mock FDA audit training (using the QSIT guidance) with recommendations for improvement
  • Regulatory support and applications (e.g., audit prep and remediation planning)
  • GxP competency support and application
  • Advanced quality planning (e.g., change control)
  • QMS assessment (e.g., state of readiness to all levels of a system hierarchy with formal finding for non-conformance)
  • QMS development for systems deficient of processes, documentation, training, and improvement
  • Global positioning of regulatory compliance in international markets
  • Supply chain compliance for QEM multi-tier products

Signs Your Organization Could Benefit from Our Quality Consulting Services

The MasterControl Quality and Compliance Consulting Team provides the education and quality consulting services regulated companies need to develop, implement, and maintain compliant quality management processes. Your organization may need assistance with its quality management initiatives if it is experiencing one or more of the following: "death by corrective action preventive action (CAPA)" due to lack of proper quality issue management; recurring issues due to poor root cause identification; costly and/or resource intensive CAPAs; difficulty in resolving FDA 483s and complex nonconformances; subjective or parallel risk management; lack of confidence in the knowledge or decisions of the quality team. Contact us today to find out how MasterControl's quality consulting services can put your organization on the path to regulatory success.

For More Information about Quality Consulting Services

For more information about our quality consulting services or on-site quality management workshops, contact the MasterControl Quality and Compliance Consulting Team or call 866.747.8767 today.

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