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MasterControl’s pharmaceutical and biotechnology audit management software is directly aligned with CGMP, FDA, and ISO regulations. Adherence to these regulatory authorities helps pharmaceutical and biotechnology companies to conform to standards and conduct business without difficulty in markets around the world. To comply with Current Good Manufacturing Practice regulations found in 21 CFR Parts 210-211 (Section 211.180), pharmaceutical companies are required to review the quality standards of each drug product on an annual basis. MasterControl’s pharmaceutical audit management systems approach to Pharmaceutical CGMP Regulations calls for an internal audit at planned intervals to evaluate effective implementation and maintenance of the quality system.
MasterControl pharmaceutical audit management software and biotechnology audit management software is an integrated quality management suite which is built to help companies attain and sustain CGMP compliance because 21 CFR Part 11 requires the validation of a software solution. MasterControl provides a unique Transfer OQ (TOQ); which puts our customers one step ahead of the competition in terms of compliance to regulatory standards. TOQ provides complete validation and supporting documentation of IQ/OQ tests performed at MasterControl. This documentation serves as evidence that MasterControl applications will perform correctly according to regulatory specifications. MasterControl TOQ not only helps companies save time and money by reducing the overall validation burden, but it is a key component of MasterControl's ongoing approach to software validation. As part of the TOQ implementation, a MasterControl's biotechnology and pharmaceutical audit management system validation expert will perform a comprehensive validation risk assessment to help the organization get started on the right track.
The following factors delineate how MasterControl's pharmaceutical & biotechnology audit management system allow companies to attain and maintain compliance by automating, streamlining, and effectively managing the processes involved in an audit.
Pharmaceutical and biotechnology companies that maintain manual audit management systems are aware of serious loopholes in their audits. For starters, it is extremely difficult to manually track findings associated with an audit. Without any concrete tracking, companies cannot effectively launch CAPAs and rectify the problems faced in execution of different processes.
Auditing is a time-consuming activity that also requires capital. Thus, companies focus on conducting successful audits that comprehensively outline the issues in the system. As a common practice, companies require a higher recurrence of audits to maintain the greatest level of product quality. This implies a steady increase in audit documentation which is difficult to maintain in a manual audit management system. MasterControl’s pharmaceutical & biotechnology audit management software solution is web-based, which helps companies maintain documentation in an online repository. Auditors will find it most beneficial to have all audit related documentation in a consolidated platform. This makes functions such as search and retrieval of documents relatively easy. To accommodate auditors at every step of the audit, the application provides advanced tracking capabilities. Through this feature, audits can be closely monitored from the start of scheduling and planning to execution and completion. Best-practice audit forms track basic audit information for each finding. In addition, the software can be integrated with the CAPA process to track related CAPAs.
It is known fact that the very nature of pharmaceutical and biotechnology audits is recursive. Audits can be internal or related to customer or compliance as per business requirements. The frequency of audits depends on the size of the company, the costs and resources involved, as well as the nature of the business. If audits are conducted manually, it is likely that dependence on human capital becomes very high. Manually conducted audits are more prone to errors especially if several audits are executed simultaneously. Such unexpected situations are easily resolved by MasterControl pharmaceutical and biotechnology audit management software with automated scheduling of all recurring audit-related activities. MasterControl allows companies to have the flexibility of conducting multiple audits without overlap.
Audit-related activities require various kinds of interactions between different employees within the company. Usually, involved team members are assigned specific tasks that must be followed up on either through email or phone. This is a time consuming process with no definite trace of communication that can ultimately lead to mismanagement. The hassle of following up with team members is completely eliminated through MasterControl's biotechnology & pharmaceutical audit management system that automates audit task assignment and follow-up via automatic email notification. Since tasks are escalated when not executed, management can be sure that all tasks are completed well before the deadline.
Usually companies rely on electronic spreadsheets, flowcharting software, or paper documents stored in binders to draw business conclusions and generate reports. These tools are disparate and insubstantial in decisions pertaining to critical points about the company’s business goals. With MasterControl’s biotechnology & pharmaceutical audit management software, management is able to develop the much needed insight in making crucial decisions. The customizable reports and online charting feature provides managers with the real-time reports that nurture a proactive attitude and improve the overall quality of the audit process.
The MasterControl Audit module is a complete and robust solution that guides auditors through each step of an audit: from the preparation to scheduling of the audit, which is then directed toward a smooth execution (including the presentation of relevant findings), ultimately allowing auditors to verify findings and bring the audit process to a close without any slippage. As MasterControl's pharmaceutical & biotechnology audit management software is 100 percent web-based; auditors and other authorized users can access it from virtually anywhere.
Accurate data collection is always a crucial task in performing an audit. During data gathering processes, multiple resources are considered and there is an expectation that data should be aggregated without any errors. In order to streamline this process, MasterControl provides two important forms to help collect and track data throughout the audit process that help promote efficiency. As per business needs, additional forms can be configured. One example of the system’s built-in forms, the audit summary form, outlines the foundation for planning and preparation of an audit. It also helps in structuring the audit in context with basic attributes such as: type of audit, date, description, objective, scope, audit area, and lead auditor.
The MasterControl biotechnology & pharmaceutical audit management system is the tool for gathering such information as: standard or regulation that serves as the basis for the audit, audit agenda, audit team members, and checklists. Once data is gathered, the next step is to track all the findings resulting from the audit. This purpose is served by the Audit Finding form that integrates risk management by providing a section for evaluating risks and gathering information such as: risk category, severity, risk of recurrence, and whether or not a CAPA is required. The same form is also responsible for tracking the verification of the process owner's response to the finding.
MasterControl has been able to conduct a thorough market survey and evaluate basic business requirements of audit processes for pharmaceutical and biotechnology companies. As a necessary condition for these companies, it is important to develop a healthy and compliant quality system with well-functioning subsystems that are seamlessly connected to each other. Such requirements call for a holistic approach that gives users the ability to launch a CAPA form directly from an audit finding form, connecting one process to the next. This chain of events is necessary for management to review a completed process and easily see what triggered that process. The MasterControl pharmaceutical & biotechnology audit management software system helps companies reduce data entry by automatically entering information from the audit finding form into a CAPA form. Thus, the software is also able to show the history of the entire process and provide managers with increased visibility into the audit process.
The backbone of the audit process is the recurrence and scheduling of audits on a regular basis within the system. MasterControl pharmaceutical and biotechnology audit management software is fully proficient in scheduling of tasks in advance so they will not be overlooked. Task scheduling is no longer manual, which eliminates human dependency. Upon completion of a task, MasterControl's audit management system has the ability to make one task dependent upon another to give managers more control of the workflow and reduce cycle time by prompting users immediately to their next task. The software also provides a dynamic, innovative dependency tree that illustrates relationships between dependent processes.
MasterControl's advanced reporting capabilities include the following customizable reports:
As the Internet has evolved, it has provided companies with unique ways to utilize web-based processes and products. Many companies are now drifting toward the concept of virtual repositories for storing data online. Along these same lines, MasterControl's Organizer, is an easy-to-use and dynamic tool for grouping audits by area, or location, or standard/regulation. These Organizers are very similar to Windows Explorer through which users can find and access documents quickly. Virtual folders can be created within Organizers that enable security measures and allow automatic retrieval of documents from the biotechnology & pharmaceutical audit management system based on pre-defined queries.
The nature of the business of biotechnology and pharmaceutical companies must be aligned with FDA and ISO regulations; otherwise they are not able to sustain their business in the market. An effective quality audit system is generally a good indicator of overall compliance. Attaining FDA and ISO compliance may be relatively easy but sustaining it is the biggest challenge. The MasterControl Audit module streamlines audit processes, fosters efficiency throughout the enterprise and keeps compliance costs down. As a company grows, so does the quality system as well as the company’s products, operations, and employees. With MasterControl’s pharmaceutical & biotechnology audit management software system, you can count on a partner that will support your compliance efforts over the long haul.