Why QMS Products Pricing About Us
The burgeoning biotech industry includes pharmaceutical companies, agricultural, mainstream manufacturing, and energy companies. Biology-based businesses produce a wide range of products (from cancer drugs to biopesticides) and develop cutting-edge technologies (from DNA-fingerprinting technology to biotech environmental processes for cleaning up hazardous wastes). Like other regulated industries, the need for an electronic quality management system in biotech companies to help control documents, training and quality processes is significant. MasterControl can help connect these processes in an easy-to-use web-based system.
MasterControl, a developer of GxP process management software, has created MasterControl Documents, the solution that functions as a biotech CMS and automates a variety of quality processes that are often unnecessarily managed with manual procedure.
Watch Related Videos|
Creating a Paperless Process Using MasterControl (3:38)
Using MasterControl for FDA Compliance (3:53)
A.P. Pharma (10:23)
The biotech industry is regulated by the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the Department of Agriculture (USDA). Products are regulated according to their intended use, and some are regulated by more than one agency. The pharmaceutical segment is covered by a number of regulations, including the FDA's 21 CFR Parts 210-211. Pharmaceutical companies are covered by 21 CFR Part 11 if they maintain electronic-record keeping systems. Many biotech companies also conform to ISO 9000 quality management standards and ISO 14000 environmental management standards.
For a biotech company developing a drug or therapy, the ultimate goal is to ensure the safety, reliability, and high quality of the product. To achieve this goal, the company must address many challenges, including:
Compliance is a state, not an event. A biotech company must not only attain compliance, but sustain it year after year. The MasterControl integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance with FDA and other regulations by automating and managing quality processes in an efficient and cost-effective manner.
Recognizing that validating a software solution and keeping it in a constant state of validation is half the battle in sustaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
To learn more about a biotechnology CMS solution, please feel free to contact a MasterControl representative regarding the MasterControl Documents solution. For additional reading (i.e. white papers, tech papers, etc.) please refer to the MasterControl Resource Center.