Quality is hard to quantify which is the reason management runs several types of audits (internal, customer, and external) for measuring the effectiveness of an organization's quality management system. The MasterControl quality audit software system allows companies to establish and maintain quality standards specific to different business areas within the enterprise.
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A variety of quality audit software solutions are available on the market but majority of these software systems are business specific and only cater to a particular market segment. Any company's executive management strives to develop effective quality policies to monitor the effectiveness and efficiency for the overall business. The general requirements of a quality management system emphasize stronger documentation controls and quality management principles. Both these attributes serve as the foundation for measuring the effectiveness of quality management system as per regulatory guidelines such as the ISO 9000:2000 policies. MasterControl quality audit software provides companies with the fundamentals for setting up a quality management system that focuses on sustaining and improving overall product quality.
The first step in conducting a quality audit is to plan the audit related tasks and activities that must take place within the audit program. The MasterControl quality audit software system provides a centralized repository for storing audit documentation including the quality manual, company policies, HR related files, and standard operating procedures in virtual vaults. All these documents are accessible to authorized users through login credentials which allow various users the opportunity to participate in the audit program.
As per ISO 9000 regulations, the MasterControl quality management system is based on a three tier documentation model. In the tiered documentation structure, the first tier is dedicated to the policies and quality manual. The second tier stores the department procedures and the third tier stores all the standard operating procedures. In order to measure efficiency of departments, management must first monitor the responsibilities of all departments and determine whether each department is working in accordance to their stated set of tasks or not. The standard operating procedures (SOPs) provide step-by-step instructions which demonstrate how a task is completed. These SOPs are then evaluated by asking two questions:
On similar lines, auditors audit the quality manual and identify issues pertaining to its authenticity and availability in the system. MasterControl's quality audit system adheres to ISO and FDA standards, which is why document control functionality is present to facilitate authorized users in updating documents. Documents can be easily searched and retrieved to accommodate auditors during an audit. ISO 9000 demands documentation to be stored in such a way that it is available to its audience without any difficulty. MasterControl Audit helps companies serve this purpose by presenting the most recent versions of documents to users, which also removes the risk of following an outdated document during a task.
Medium to large-scale enterprises may find it difficult to attain quality in comparison to small-scale firms. Adherence to FDA and ISO regulations has also become a factor which cannot be overlooked. Developing a sound quality management system is an effort of long-term planning and incremental shifts toward the development of electronic business systems. The current wave of technology has highlighted the option of conducting audits with minimal human intervention. MasterControl's quality audit software system allows for the planning and scheduling of round-the-clock audit programs that adhere to latest standards set by the FDA and ISO regulatory authorities. Auditors only have to monitor the ongoing audit activities while the program executes without any hassle. The advanced audit finding forms help in storing the audit results which can be analyzed for deducing various conclusions. The reporting facility helps in generating reports and building a profound understanding of the weak and strong business areas within the company's domain.
MasterControl quality audit software helps in attaining and sustaining compliance. The advanced CAPA functionality allows users to rectify issues that are identified during an audit. MasterControl Audit can also be integrated with other MasterControl suite of applications such as the MasterControl Training module which helps in preparing training programs to educate employees about different business areas and processes in the system. This helps companies save capital and resources that may otherwise need to be spent building extensive training programs.
With MasterControl's quality software, companies of any magnitude can establish and maintain a quality management system comprised of sound quality policy, goals with efficiently allocated resources, and effective processes.
Whether you are looking to learn more about quality audit software systems or our exceptional products and services, MasterControl's team of experts is on hand to answer your questions. To learn more about implementing a software solution, call us toll free at 800-825-9117 or contact MasterControl online.