Enterprise Quality Management and Regulatory Compliance
W. Edwards Deming, the world-renown advocate for quality control, once said: “quality is everyone’s responsibility.” In life science and other regulated industries, quality is incorporated in all phases of the development process: drug discovery (for pharmaceuticals) or design and prototype (medical devices), pre-clinical trial, clinical trial, manufacturing, and post-marketing.
Regulated companies are required to control all quality processes as part of their compliance efforts. An enterprise quality management system typically encompasses the different processes in all phases. Common problems that an enterprise quality management system should address include:
- Need to share the same information and data among different sites, departments, and stakeholders for purposes of compliance
- Ability to separate its data from other sites as needed, such as training tasks, which tend to vary for every department and from site to site.
Enterprise Quality Management and Business Efficiency
For companies that are not regulated, an enterprise quality management system can be very helpful in improving efficiency and productivity by allowing different departments within an organization to work together under a common platform. These companies might also have geographically dispersed business units that need to become part of the corporate enterprise quality management system.
For non-regulated companies, the focus is more on gaining a competitive edge in the global market. Some of the common problems that an enterprise quality management system should address include integrating different systems used by different departments and business units, and having a single system administrator manage multiple systems. Both problems could seriously impact enterprisewide efficiency and productivity.
Using MasterControl for Enterprise Quality Management
MasterControl quality and compliance software is an end-to-end solution that automates and connects all quality and business processes to help regulated companies accelerate compliance and time to market and to help all other types of organizations increase efficiency and cost-effectiveness.
MasterControl offers the flexibility and scalability for enterprise quality management throughout your organization. Here are some of the benefits and advantages offered by MasterControl:
Single Web-Based Platform: If your company has 10 facilities or business units, you don’t need 10 different systems. With MasterControl, you will have a single enterprise quality management system that is scalable to cover the entire enterprise: different sites and facilities, multiple business units, and different departments. MasterControl is web-based, which means the application is not locally based so physical distance and time-zone differences among users are irrelevant.
Easy-to-Manage Processes: With MasterControl, your enterprise quality management system will be easier to manage. Each site or department will be able to maintain and streamline its own processes and still remain connected to the corporate headquarters and other units. The individual units and departments don’t have to rely on corporate headquarters to manage their processes. This covers not only documents and forms but also training tasks, which might be different for every department or site.
Filters for Different Units: Each business unit, site, or department can focus only on data relevant to the entity because MasterControl’s enterprise quality management system provides robust filters that will facilitate the sharing only of appropriate data.
Enterprisewide Connectivity: Sometimes even when different units within an organization use the same system, they still have problems connecting with each other. With MasterControl, all quality and business processes will be connected for a seamless approach to enterprise quality management. In terms of quality compliance, connectivity means more timely and proactive response to quality issues. For example, by integrating document control with training control, any substantial revision to an important SOP could invoke training to affected users upon approval of the SOP revision. For business units or departments involved in cross-functional projects, a connected system means faster and more convenient means for routing, review, escalation and approval of documents and forms.
Learn More about MasterControl's Enterprise quality management software system
To learn more about MasterControl’s Enterprise quality management, contact a MasterControl representative.