Sarbanes-Oxley - SOX Compliance Software Key Factors

Life science organizations, including pharmaceutical companies, medical device manufacturers, and blood establishments, must comply with FDA requirements ? among the toughest regulations that exist today. Manufacturers ? from other industries like automotive and aerospace ? must conform to ISO standards to compete in the international market. On top of the rigors of FDA compliance and ISO-certification, publicly owned life sciences and manufacturing companies (or those planning to go public or are acquired by a public company) face additional regulation by the Securities and Exchange Commission with the recent enactment of the Sarbanes-Oxley Act.

Why is MasterControl SOX? Right for You?

MasterControl SOX?, an integrated part of the MasterControl™ quality management suite, is an easy-to-use and complete software solution for automating and managing SOX testing and risk management processes. Just as MasterControl has helped hundreds of life sciences companies comply FDA requirements and hundreds of other manufacturing companies meet ISO requirements, MasterControl SOX will further help them in their SOX compliance efforts through the following powerful features:


	Compliant. Sustained Compliance: MasterControl believes that compliance is a state, not an event. The MasterControl SOX™ is designed not only to help companies attain compliance, but to sustain it year after year by simplifying the compliance environment, improving efficiency, and keeping overall compliance costs lower. Increased Efficiency Through Automation: MasterControl automates all tasks pertaining to SOX compliance, including task assignment, routing, follow-up, escalation, review, and approval. Automation helps simplify the SOX environment, making it easier to stay compliant. Preconfigured Form: MasterControl provides a preconfigured form that documents and collects data pertaining to the most important elements of SOX compliance: risks, internal controls, and tests. Risk-Control-Test Assessment Tool: This innovative tool reduces the time and effort needed in establishing new SOX cycles by allowing importation of RCT data from current disclosures en masse, configuring scheduled tasks for all tests, and allowing exportation of RCT data in bulk for subsequent compliance efforts. Analytics and Reporting: MasterControl's advanced analytics and reporting capability increases management oversight. Customizable reports include risks/controls/test matrix, risks by business process/financial statement, significant control report, significant risk report, test summary by control, test failure/exception report, and open tasks/overdue tasks report. Record Retention: With MasterControl, a company doesn't have to keep sensitive records longer than it needs to. A new feature gives the option to retain records according to company policy ? anywhere from 24 hours to several years or longer. Retention can be configured by document type. Process Change: Templates from current disclosures can be easily modified for future compliance and easily updated when an important financial issue that requires immediate reporting arises. Changes are automatically tracked. SOX compliance history will always be accessible. Secure E-mail Repository: As more and more people conduct business via e-mail, there's a need to control e-mail messages. With this feature, users can forward important or sensitive e-mail messages to the MasterControl system, where they are automatically added to the secure repository. Combined with the records retention feature, sensitive e-mail documents can be automatically expunged when they are no longer required. Dynamic Organizer: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool for grouping and correlating financial statements with the appropriate business processes, controls, and tests. Documents can be rearranged in different Organizers for future compliance work without changing the documents themselves. System administrators can automatically update the documents through a dynamic link in the InfoCard, the MasterControl tool that provides basic information for every record.

	Connected. Integrated Quality Management: MasterControl connects SOX processes under a single Web-based platform, linking risks, controls, and tests for traceability. Manage Different Document Types: MasterControl is uniquely qualified to be the focal point of any compliance initiative because it can manage different documents-based processes and handle all types of documents regardless of the software used to create them. Easy Access: MasterControl is Web-based so it can connect employees, executives, auditors, and others involved in SOX compliance from virtually anywhere. The system is secure so only authorized users will have access to documents. Electronic Sign-Offs: With MasterControl, it's easier to get executives to complete or verify surveys and attestations without the legwork. Documents can be signed and approved electronically. Signature manifestation ? name, date, time, and meaning of electronic signature ? can be appended automatically to each document. Integrates with Training: MasterControl provides the option to integrate the SOX application with training, so any critical change in SOPs and processes will automatically trigger a training task for all concerned. Centralized Repository: Even when employees and executives are scattered in different locations, all SOX-related documents will remain in a centralized repository, making search and retrieval easy. External auditors will be able to retrieve documents and testing results easily, making it possible to save in billable hours.

	Complete. Enterprise-wide Product Application: In addition to SOX process management, MasterControl believes that quality initiatives must be integrated into an organization's corporate culture. The MasterControl integrated quality management software solution helps companies ensure that quality standards are enforced across the enterprise. Its platform is powerful enough to meet the needs of every department in an organization — R&D, quality control, engineering, manufacturing, purchasing, sales and marketing, human resources, and corporate management. Its robust features enable adherence to various FDA GMP and ISO quality standards. Control, Tracking, Monitoring: From R&D to accounting and finance, there is a common need to control documents (and changes), to track and follow up tasks, and to monitor processes. MasterControl can unify different processes, from the quality and manufacturing side of a life science company to corporate management, for a holistic and cost-effective approach to compliance. Integrates with Other Applications: MasterControl can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs. Pre-defined Workflow: Company-wide policies, SOPs, and other documents that require inter-departmental collaboration move along a pre-defined workflow, from one department to the next. Overdue tasks automatically escalate to a manager. Automation of Forms-based Processes: Any forms-based process unique to a department (i.e., application forms for HR, 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 ones. Easy to Search: A standardized "Google-like" search window is available throughout the application, which means all authorized users throughout the organization can search for tasks, policies, and other documents using a familiar search interface.