A contract research organization (CRO) is a strategic partner hired by pharmaceutical and biotechnology companies to perform clinical trials and other critical drug development services on their behalf. CROs deal in a life-sensitive business, where any small error can yield harmful repercussions. Because the need to ensure quality is paramount, many CROs conduct audits to evaluate their quality, compliance, and work flow procedures. MasterControl's CRO audit management software helps streamline the auditing process by automating and managing all critical quality and compliance processes using a centralized system.
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A well-maintained quality system is compliant with regulatory standards. It is also connected, enabling it to measure quality and compliance processes using a single, centralized system. The quality system must also be complete to allow users to perform a wide variety of different operations with efficiency and ease. The following sections elaborate on how MasterControl CRO audit management software ensures that your quality system is always Compliant, Connected, and Complete.
As financial and regulatory pressures continue to rise, more and more pharmaceutical companies are outsourcing to CROs to help them manage their drug discovery and development processes. In turn, more and more CROs are turning to technologies like MasterControl's contract research audit management software, which has been carefully designed to align the CROs clinical research activities in accordance with GLP and GCP regulations, for assistance in attaining compliance with clinical trial protocols. Attaining compliance, however, is only one part of the picture; sustaining compliance is the other challenge that is also achievable with MasterControl. In order to attain and sustain compliance, CROs can execute audits that are automated on particular schedules. Management can automate any stage of the audit process, including notification, follow up, and escalation of overdue assignments. Automation simplifies the compliance environment and makes it easier to stay compliant. Auditing allows CROs to track issues in the system and gather important data for further analysis.
MasterControl's CRO audit management software provides two important forms to collect and track data throughout the audit process. CROs can configure additional forms, as needed, to accommodate additional business requirements. After the data is collected on a form, it is stored in a centralized repository, which is readily accessible to all authorized users. With the automatic revision control feature, management can be assured that only the most recent version of a document is available, minimizing the potential for errors caused by duplicate data entry.
Once data is made available, it is important to able to present it in an easy-to-interpret format that facilitates further analysis and decision making. MasterControl's CRO audit management system contains advanced analytics and reporting capabilities. It offers users the ability to dynamically capture, trend, and link the data needed to solve problems and improve processes. Reports are segregated in different sections, such as audit summary, audit detail, findings by root cause, audits by standards, audits by auditor, and open findings, so that information can be quickly located and easily referenced during an audit.
As organizations vary in size, so does the volume of data and solutions each company utilizes. With multiple processes working in parallel, it is essential that the audit management system allows for communication between processes and other systems, such as an ERP. Collaboration allows for increased cost savings and ROI; this is the reason CROs require harmony and collaboration between people and processes. MasterControl connects the audit process with other quality processes for a holistic approach to quality management.
MasterControl streamlines the audit process by integrating the different steps (preparation, scheduling, execution, findings, verification, and completion) with one another. Because MasterControl's contract research organization audit management software is web-based, it is able to connect all of the users involved in the audit process, such as employees, suppliers, and contractors, regardless of their location.
Once an audit is complete, a CAPA can be launched directly through the Audit Finding Form. To eliminate duplicate data entry, all information from the Audit Finding Form is directly entered into the CAPA. The entire audit history is maintained and can be viewed by users at any stage of the audit process. Users can also review the completed process to see what triggered the CAPA.
To provide managers with a comprehensive collaborative experience, the completion of a task can be required to be dependent on another task. This gives managers more control over workflow and reduces cycle time by prompting users to immediately proceed to their next task. To view the dependency of processes, the software displays an innovative dependency tree.
Regardless of company size, MasterControl CRO audit management software allows you to manage audits, as well as forms-based and document-based processes throughout your entire organization, making it an ideal enterprise-wide solution to securely measure and ensure quality throughout all aspects of the clinical trial process.
To accommodate individual departmental needs, MasterControl contract research organization audit management system is able to seamlessly integrate with other applications like ERP, LIMS, accounting, and human resources applications. With the web-based repository, all documents are easy to search, allowing all authorized users throughout the organization to search and retrieve change control-related tasks and documents.
Documents are also easy to find with the help of the MasterControl Explorer, which allows users to locate and access documents quickly. For added convenience, each department is able to maintain its own Explorer within the CRO audit management system. Moreover, system administrators are the only users who can control and automatically update the documents through a dynamic link in the InfoCard.
The software also automates form-based processes unique to each department, for example, application forms for human resources or customer satisfaction survey forms for the customer service department can also be automated. To give each department a customized look and feel, management can also configure entirely new forms or maintain existing forms.
For more information about a CRO audit management software systems, please feel free to contact a MasterControl representative.