Electronic GCP audit management software systems such as MasterControl Audit enable highly regulated companies to adhere to stringent FDA standards and global good clinical practice (GCP) regulations by helping them track and manage a wide range of audit-related activities, data, and processes.
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Medical and clinical establishments rely on the accuracy and quality of tests that are conducted on different DNA and blood samples. To ensure that quality is maintained, it is necessary to implement a quality GCP audit management software system. With MasterControl GCP audit management software, companies can address and resolve many of the challenges discussed in the succeeding section.
As companies grow, they often expand to multiple locations. Typically, this means that the number of employees and the amount of documentation the employees produce increases significantly. Processes running in the system are heavily dependent on sound collaboration between different departments. Similarly, each department is running procedures based on documented standards. In paper-based or hybrid GCP audit management systems, it becomes increasingly difficult to maintain documentation. For example, if an employee makes an alteration to a paper document, other employees may not be informed about the change, raising the risk of having multiple versions of the same document in the system. As a result, the company faces greater risk of non-compliance with FDA and GCP standards.
The only way to bring quality to the system is by executing different types of audits on particular schedules. Through timely audits, management can assess whether the SOPs in the system are executing in accordance to the documented standards. Any variance can be spotted at any earlier stage and quickly corrected by launching a corrective and preventive action (CAPA). With MasterControl GCP audit management software, companies can more easily adhere to FDA and GCP regulations. The web-based repository is a centralized portal that is readily accessible to authorized users. SOPs, HR policies, and any other company documents are stored online. This eliminates many of the inefficiencies associated with paper-based and hybrid systems, such as consulting outdated documents, obtaining timely approvals and signatures, numerous face-to-face meetings to discuss changes, and the manual search and retrieval of documents during audits and inspections.
Successful companies rely on good communication between people and processes. Quality in the system requires good collaboration as well. With multiple processes running simultaneously in the system, it is likely that processes are dependent on each other. In a compliant environment, it is important for processes to be connected. This means that the output of one process can become the input of another. In order for departments to work together coherently, it is important to establish a protocol for communication.
In paper-based systems, most of the communication takes place without any tracking. If a change to a process is discussed but not actually documented or not correctly implemented, the company may face serious losses. For example, a change control process that is not connected to a document control process is likely to cause delays in change implementation. Therefore, transparent communication is the key to any successful business. Miscommunication is handled by implementing MasterControl's GCP audit management software systems. People and processes in the system are provided a common platform so that stakeholders are aware of all changes made to processes. This brings transparency and allows management to closely monitor processes to ensure there is no deviance from the documented standards.
In order to adhere to 21 CFR Part 11 regulations, companies must ensure integrity of electronic records and signatures through computer system validation. This is another difficult challenge for companies still maintaining their documentation through paper-based or hybrid systems. Even if a company successfully automates its manual record keeping system, it still faces the daunting task and the high cost of validation. Labor-intensive validation tests conducted by internal staff, in addition to exorbitant consultant fees, can easily double a company's compliance costs. MasterControl’s GCP audit management software system ensures that the system is validated and compliant with FDA regulations, allowing companies to avoid having to hire validation resources. Because the entire audit process is automated, the integrity of all quality processes is guaranteed.
To learn more about MasterControl's GCP audit management software systems, please contact a MasterControl representative.