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With MasterControl, You Don’t Trade Efficiency for Compliance

If you’re in a highly regulated industry, it can feel like you have to give up efficiency in order to make safe, reliable products while documenting it for regulators . What if you could have both all while delivering critical treatments to your patients? ​

MasterControl’s MES and QMS solutions increase your operational efficiency while ensuring compliance with regulations. Our solutions reduce risks while improving time-to-market and quality. Leading manufacturers choose MasterControl for:

  • Embedded quality into manufacturing operations.​
  • Custom workflows across all systems eliminating inefficient paper processes.​
  • Faster records release with review by exception.​
  • Workflow validation with a click of a button.​
  • Flexible pricing to fit Small and Medium Businesses up to Enterprise needs

Quality Management System

Get quality in order with the world’s most trusted QMS.

 Document Control

Looking for an efficient quality document control software? Implementing a digital solution brings automation and streamlines your processes, keeping you effortlessly updated with regulatory changes for easy compliance. Find out how MasterControl’s document control software, Quality Excellence, can help your company with your document management processes.

In regulatory environments, effective document control plays a critical role, impacting all quality processes. With MasterControl’s Quality Excellence, a robust quality document control software, you can ensure regulatory compliance with even the strictest regulations and standards while reducing overall costs. Experience accelerated time to market with our advanced solution.

Change Control

Document change control software is essential for ensuring compliance and managing change in regulated industries such as life sciences and manufacturing. By utilizing this software, companies can effectively address the complexity of change control and streamline their operations.

In regulated environments, the term “document change control” encompasses both the document management/control process and the rigorous documentation involved in the change control process. Regardless of the specific context, most companies rely on document change control software to efficiently manage these critical processes. By implementing document change control software, businesses can track and monitor changes, collect relevant data, and facilitate the approval process. This software provides a centralized platform to ensure all changes are properly controlled and managed throughout the organization, promoting regulatory compliance and mitigating risks. With the use of document change control software, companies operating in regulated industries can navigate the intricacies of change control, enabling them to adapt swiftly while maintaining compliance with industry regulations and standards.

Quality Events and CAPA

Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

Improving quality and maintaining compliance depends upon a robust CAPA management software. The purpose of CAPA is twofold: to determine why quality events such as nonconformances and deviations have occurred, and to prevent them from happening again. By nature, CAPA processes span various quality systems and the data they produce. A digital and integrated CAPA solution allows companies to connect key quality channels and downstream processes throughout the entire product life cycle. The result is a streamlined and thorough CAPA management software for better product quality, safety and overall compliance.

Compliance and Audit Management

Streamlining Audit Compliance with MasterControl’s Audit Management Software

MasterControl’s audit management software system offers an integrated solution to help companies successfully navigate regulatory audits. By automating tasks and ensuring compliance with a wide range of internal and external standards, this software simplifies the audit planning process and minimizes the time and effort required to pass audits.In today’s regulatory landscape, companies face various audit requirements, including those from the U.S. Food and Drug Administration (FDA), International Organization for Standardization (ISO), as well as laboratory, clinical, and quality audits. Failing to comply with these standards can be both costly and detrimental to your bottom line. However, with an audit management software system in place, you can confidently face audits with streamlined efficiency.MasterControl’s audit management software integrates seamlessly with a quality management system (QMS), ensuring accurate and complete documentation throughout the audit process. By automating audit-related tasks, this software reduces the burden on teams, enables effective collaboration, and facilitates the collection of necessary evidence. This comprehensive approach significantly enhances your ability to meet audit requirements and achieve regulatory compliance.With MasterControl’s audit management software, companies can proactively prepare for audits, maintain audit-readiness, and reduce the risk of compliance issues. By optimizing efficiency and accuracy, this software empowers organizations to pass audits successfully, saving both time and resources.

Training Management

Make sure gaps in employee training don’t derail your regulatory compliance.

MasterControl’s training management software greatly improves your employee training program. It automates all training tasks, from routing and tracking to follow-up and escalation. Your compliance will never be at risk due to lack of employee training.

Manufacturing Execution System (Integrated & Stand-Alone Deployments)

Choose an agile and affordable MES. 

 Electronic Batch Records (EBR)

Ensure compliance and improve efficiency by automating your paper-based systems with an integrated EBR system, like MasterControl Manufacturing Excellence.

The U.S. Food and Drug Administration’s (FDA) Current Good Manufacturing Practices (cGMPs) require proof of proper handling for every step of the production process. Batch records and other types of manufacturing documentation demonstrate this level of accountability. Paper-based systems are cumbersome and error-prone. An electronic batch record (EBR) software system, such as MasterControl’s Manufacturing Excellence, removes the documentation burden from quality and manufacturing teams. It also improves product quality and key performance metrics.

Electronic Device History Records (EDHR)

MasterControl’s eDHR software revolutionizes the DHR process, offering unmatched control over manufacturing data and documentation.

Seamlessly connecting production and quality, our integrated eDHR software empowers medical device manufacturers with enhanced efficiencies and invaluable insights. Streamline and error-proof your DHR processes while ensuring top-notch quality throughout production with MasterControl.

Variant Management 

MasterControl offers the tools needed to digitize, document and manage all your product variations.

Manufacturers don’t need to use manual systems to manage product variations. This approach is time-consuming and error-prone. The variant management software included with the MasterControl Manufacturing Excellence™ solution can help. Handle multiple product recipes and product family variations with ease, and expand product lines without any hassle.

Equipment Calibration

MasterControl software automates equipment calibration processes. It helps manufacturers improve their performance and ensure audit-readiness.

An automated equipment calibration system manages your calibration schedule and automatically prompts calibration events before the due date. It routes calibration tasks to the appropriate personnel and provides advanced reporting capabilities. A complete record with calibration data is stored for audits and inspections.

Recipe Management 

Automate batch processes. Improve efficiency. Ease growing pains. A proven recipe management software system can help you do it all.

Recipe variations and substitutions are common in manufacturing settings that rely on batch processes. In fact, they play a vital role in a manufacturer’s ability to increase market shares and expand into new markets. The manufacturing recipe management software in the MasterControl Manufacturing Excellence™ solution eliminates manufacturers’ manual recipe-related processes and provides smart variant design and variant management functionality.