In the FDA and ISO environments, the concept of change control is closely interwoven with compliance. Contract research organizations (CROs) and other contract manufacturing organizations that help develop and manufacture medical devices are required under the Quality System Regulation ( 21 CFR Part 820) to establish control over design changes (820.30), document changes (820.40), and production and process changes (820.70). MasterControl's CRO change control software is an integrated quality management suite that is configurable, easy-to-use, and helps CROs attain and sustain compliance.
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Most contract organization operations require changes to procedures. The majority of these changes are initiated through customer requests or audits. As a requirement to remain compliant, all changes must first be analyzed and approved. The change approval process must be extremely rigorous to eliminate any risk of introducing unapproved changes to procedures and thereby invalidating the safety analysis. The alteration can be temporary or permanent as required by management. An effective change control process helps derive methods through which changes are proposed, evaluated for safety, approved, scheduled, implemented, and documented.
MasterControl's contract organization change control software systems are designed to help contract organizations automate and effectively manage every step of the change control process, from submission through actual implementation, verification, and close of project. The solution's change control process facilitates configuration management by allowing various departments to spot any discrepancies prevalent in current procedures so that they are easily indentified, controlled, and prevented from recurring.
MasterControl contract change control organization software guarantees compliance with regulatory standards including the globally prevalent FDA and ISO regulations. In order to remain valid, contract organizations must take all the precautionary steps to ensure that they are able to attain and sustain compliance with the FDA and similar regulatory guidelines so that they can continue practicing business without any adverse issues.
Various types of users - employees, stakeholders, vendors, etc. - work together to bring processes to culmination. Therefore, it is important to maintain flawless communication between users associated to all applicable processes. Any breakdown in this flow can disrupt the implementation of a change in the system. This is the reason manual or paper-based contract organization change control systems are inadequate and in need of being replaced.
MasterControl contract organization change control software is specifically designed on the principle of collaboration. MasterControl ensures that the follow-ups and notifications pertaining to tasks are carried out without any slippage. Moreover, managers can use the system to escalate incomplete tasks in order to expedite reviews so that the necessary documentation is readily available. The MasterControl change control software system also enables users to make proper and timely notifications. As MasterControl is Web-based, even suppliers and others outside the company (off-site or traveling employees) who need to participate in change control can do so from virtually anywhere.
With MasterControl's CRO change control software system, the completion of a task can be made dependent on another task. This gives managers more control and reduces cycle times by prompting users immediately to subsequent tasks. The system's innovative dependency tree illustrates the relationships between dependent processes.
Time is a valuable factor for contract organizations, which is why management must always sure to effectively plan all activities within the system so that all change control processes are optimized. With legacy contract organization change control systems, routing and submitting tasks take an inordinate amount of turn-around time. While with MasterControl's contract organization change control software, the entire change control procedure is streamlined for efficiency and faster turn-around. It offers a best-practice form that incorporates priority level (by identifying the change as routine or temporary or emergency) as well as escalations. Plus, system reports provide real-time status for all change control tasks.In a nutshell, the features available in the best-practice forms include:
After a change is implemented, it is also important to educate employees about the change so that they are sufficiently able to incorporate alterations into daily practices. Manual or paper-based change control systems lack the necessary tools to facilitate training sessions for employees, meaning that the company must spend money on conducting proper training on the new changes. However, MasterControl contract organization change control systems can be integrated with the training application which helps in updating documents impacted due to the change. As a result, the updated documents automatically invoke new training tasks within the software system. With the help of integrated training, online exams and grading can be easily carried out which helps management save valuable capital and time.
The MasterControl contract organization change control system is designed to aid top level management in the evaluation and assessment of data pertaining to change control processes. The MasterControl change control software system helps in monitoring emergence of any potential risks that may disrupt the system.
Data can be grouped together by a date interval and then charted over a date range in the CRO change control software system. For example, the number of customer complaints that have led to a change can be totaled for each week and charted for the last year. Data can be summarized in multiple levels, so change orders can be reported by product, department, root cause, etc. With better representation of data, management has an upper hand in evaluating the data and forecasting any occurrences of risks that threaten the company's compliance with regulations.
To learn more about CRO Contract Organization Change Control Software Systems Change Control Software Systems, please feel free to contact a MasterControl representative.