Internal Quality Audits

Regulatory bodies such as ISO and FDA have laid out certain rules that companies from different industries must adhere to. In order for businesses to thrive and grow, companies must take precautionary measures to remain compliant with the established guidelines. Conducting internal quality audits on a regular basis helps in optimizing quality processes and keeping the quality system always ready for internal audits as well as third-party performance and compliance audits.

For starters, MasterControl Audit is web-based. It provides a centralized repository for storing all audit-related in a secure environment. This allows auditors to perform quick searches and retrieve documents during an internal control audit without any hassle. In paper-based or hybrid systems, conducting an internal quality audit can be cumbersome and error prone. It gets difficult to keep track of the most recent version of any document, which presents the risk of referring to an outdated version of a document during the audit. However, MasterControl Audit provides a revision control feature that tracks all iterations of a document and ensures that relevant personnel are working only with the most current version of the document. Since internal control audits conducted through MasterControl Audit are automated, it facilitates auditors in automating tasks within the audit process. Processes such as notification, follow-up, and escalation of overdue assignments are greatly simplified using MasterControl's automated system. Automating tasks streamlines the assignment of tasks and enables different audits to be easily managed at the same time. The system's advanced scheduling feature allows the scheduling of all tasks pertaining to an audit to take place well in advance of the audit. This helps auditors in planning audits and ensuring that no task within an audit is overlooked.

With MasterControl Audit, collecting and tracking data is facilitated through best practice electronic forms. Additional customizable forms may also be configured to meet customer requirements. Once data is collected and stored, management can use MasterControl to generate different types of reports to dynamically capture, trend, and link data needed to solve problems and improve processes. Standard internal quality audit reports include audit summary, audit detail, findings by root cause, audits by standards, audits by auditor, and open findings. In addition to these and other standard reports available for performing internal quality audits, MasterControl Audit provides the GLP-required Master Schedule and QA Statement and the GCP Compliance Statement for effective audits that are driven by regulatory compliance.

Internal quality audits conducted through MasterControl Audit provide a holistic approach to quality management by connecting the internal audit process with other quality processes. Internal quality audits are connected on various levels. First, the system enables different authorized users such as employees, suppliers, and contractors to contribute to the audit process from virtually anywhere. This allows management to involve various stakeholders in planning and making crucial decisions about internal quality audits. Secondly, processes within the internal quality audit are divided in steps such as preparation, scheduling, execution, findings, verification, and completion. These divisions allow for better planning, manageability, and data capturing during each step of the audit. Corrective and preventive action (CAPA) forms can be automatically launched from an internal quality audit form to rectify an issue in a process.

For better resolution of the issue, the software transfers pertinent information from the Audit Finding form into the CAPA form, thereby reducing potential human errors. The history of the entire process can be viewed through links that also help in reviewing completed processes and identifying what triggered the CAPA. To give managers greater control of the workflow and reduce cycle time, the completion of a task can be made dependent on another task. This can greatly speed up the process for internal quality audits. MasterControl offers an innovative dependency tree that illustrates relationships between dependent processes.

MasterControl's internal quality audit software can handle every department's forms- and documents-based processes, making it an ideal enterprise-wide solution. MasterControl is highly configurable to better meet the requirements of businesses of any magnitude. MasterControl Audit can be readily integrated with applications like ERP, LIMS, accounting, and human resource applications to accommodate departmental needs. Authorized users can conduct elaborate searches through a standardized Google-like search window for searching documents and tasks related to internal quality audits. Similarly, MasterControl's Expxlorer is an easy-to-use tool that helps users find and access documents quickly. The software allows Explorers to be configured for each department and for department data to be stored separately in respective Explorers.

System administrators can control and automatically update documents through a dynamic links. Any forms-based process unique to a department-such as application forms for HR or customer satisfaction survey forms for Customer Service Department-can be automated. A department can keep the look and function of existing forms or create entirely new internal quality audit forms.