Our System - for Small Businesses

 

Small Businesses    |   Midsize Companies   |  Large-scale Enterprises

 

Whether it's a start-up biotech company with a dozen employees, or an established paint company with 60 employees, small companies in stringent FDA and ISO environments face tremendous pressure to balance their compliance needs with their business objectives.

The small FDA-regulated biotech company may have been in existence for only a few years, and is looking to install its first automated quality management system while it pursues extensive R&D on a new medicine. Although the company has not yet submitted a new drug application to FDA, it must establish a history of compliance for faster approval later on.

On the other hand, the paint company may have been in business for many decades, with an established niche market for its special coatings used for OEM metal products. Now the company wants to expand its business overseas. One way of doing it is to get ISO 9000 certification, which is required by many of its target customers.

MasterControl™ for Small Businesses

The MasterControl™ integrated quality management suite is a configurable, off-the-shelf, and easy-to-use software solution that facilitates FDA and ISO compliance for small companies. MasterControl automates, streamlines, and effectively manages document control, change control, training management, audits, corrective/preventive action (CAPA), customer complaints, and other forms-based quality and business processes under a single Web-based platform.

There are three key factors that make MasterControl an ideal solution for small companies in regulated industries:


Compliant.

MasterControl is designed not only to help companies attain compliance, but to sustain it year after year by: (1) automating and streamlining quality processes to make the compliance environment simpler; (2) providing advanced capabilities that anticipate, if not eliminate, common quality issues that cause noncompliance; and (3) optimizing quality processes to promote efficiency and reduce overall cost of compliance.


Connected.

MasterControl connects people, processes, and data for a holistic quality management. This connectivity gives managers the ?big picture? ? allowing them to view and monitor the entire quality system to continuously improve it and to proactively reduce, if not prevent, quality problems that could lead to product recalls, returns, waste, and rework.

For FDA-regulated companies, MasterControl's integrated solution also means system validation can be performed just once.


Complete.

MasterControl offers robust software, plus the appropriate tools and services necessary for successful implementation and validation, including:

  • Continuous Validation: For FDA-regulated companies, MasterControl offers a ?continuous validation? approach that dramatically cuts the time, pain, and cost of validating a system. MasterControl's continuum of products and services address different validation needs based on individual risk assessment.

  • 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 Training 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.


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