In the FDA regulatory environment, the concept of change control is closely interwoven with compliance. Companies that produce FDA-regulated products are expected to establish Pharmaceutical and Biotechnology change control software systems as a way to improve product quality and safety and to ensure compliance. Under the Current Good Manufacturing Practice (CGMP) regulations outlined in 21 CFR Parts 210-211, pharmaceutical companies are required to control any change to established processes, meaning the change has to be recorded, reviewed, and approved by a quality control unit.
Feel free to download information below about our change control solution:
Sélectionnez toutes les ressources que vous souhaitez télécharger.
Change control is a necessary component of ensuring a smooth introduction to updates made to existing procedures or the integration of an entire new process in an existing business model. Change control is always complex, requiring careful planning and flawless execution. The ineffectiveness of properly implementing change control in pharmaceutical and biotechnology companies can yield to severe repercussions including product recalls, internal confusion, and serious violation of Quality System (QS) regulations.
MasterControl pharmaceutical and biotechnology change control software systems are specifically designed to address the ever-changing needs of pharmaceutical and biotechnology companies. Change control activities pertain to design processes that are related to manufacturing, documentation, standard operating procedures, and so forth. With MasterControl pharmaceutical and biotechnology change control software systems, companies can be assured of flawless change control that is compliant with FDA and ISO guidelines. MasterControl also offers full-cycle validation services for pharmaceutical and biotechnology change control systems, including IQ, OQ, and PQ validation tests. With less time involved in validating the software system, MasterControl makes it easier to validate implementations and upgrades, both of which are essential in lowering overall validation costs.
Compliance with CGMP, FDA, and ISO guidelines is a necessity for pharmaceutical and biotechnology companies. Attaining and sustaining compliance with these regulations is a chain of continual improvement in processes which is why MasterControl provides automation of change control processes. For starters, it is important to collect and track data on various change control process stages. MasterControl's best practice forms allow users to collect and track data from several sources so that data does not fall through any cracks and is securely collected through different stages of change control including submission, evaluation, approval/rejection, implementation, verification, and close of project.
Accurate implementation of any change is heavily dependent on documenting any updates made to a process so that the changes are emulated by users throughout the enterprise. MasterControl allows authorized users to check out documents for revision and collaboration with various stakeholders. Meanwhile, remaining users can still refer to the previous version of the document. Once the document is revised, approved, and updated in MasterControl's online repository it replaces the existing version and is made available to all users for referral.
Since our pharmaceutical and biotechnology change control software is completely web-based, it allows all change control process tasks to be automated. Automation simplifies the compliance environment and makes many tasks - such as notification, follow-up, and escalation of overdue assignments--a relatively easy for the users.
Our software enhances the management's oversight with advanced analytics and reporting tools that help capture, trend, and link data for solving problems and accurately capturing high-level operations. To help continually improve processes, management can generate timely reports to assess the progress of departments, analyze the root causes behind issues, and observe the parameters involved in manufacturing products. With MasterControl all these areas have the capability to present data on multiple levels and help management build an overall picture of the business.
Realizing the importance of integrated quality management, MasterControl has designed its pharmaceutical and biotechnology change control software systems to connect the change control process with other quality processes for a holistic approach to quality management. MasterControl pharmaceutical and biotechnology change control software is completely online which makes it easier for employees, suppliers, contractors, consultants, and others to connect and be involved in the change control process regardless of location. Since change control forms often must be launched after a CAPA is raised in the system, MasterControl allows automatic form-to-form launching in order to reduce data entry and minimize chances of entering incorrect data in the system. Users can also review a completed process through links and view the reason that triggered a change.
MasterControl tools can be used to define dependencies of tasks on each other so that a task can only be completed upon completion of another task. This child-parent relationship between tasks enriches the roles of managers, who are able to control task workflow and prompt users to immediately move to the next task at hand. The efficient routing of documents is also an effective method in reducing document approval time as documents are electronically approved and signed off by authorized personnel without excessive delays. To keep a an ongoing tab on reviewers and approvals, - the names, dates, times, and meanings of electronic signatures can be appended automatically to each document.
MasterControl pharmaceutical and biotechnology change control systems are enterprise-wide product applications that handle every department's forms and documents-based processes. Regardless of the size of the business, our software integrates with different applications such as ERP, LIMS, and HR applications, making it easier to incorporate change control process into existing procedures without any hassle. To accommodate users performing searches, MasterControl provides a Google-like search window that simplifies the search and retrieval of change control-related tasks and documents. (It should be noted that the majority of change control tasks rely on quick search and retrieval of documents.)
With the inclusion of MasterControl's Explorers, users can store documents that can be updated with the help of dynamic links in each document's "InfoCard". Moreover, various departments can also automate form-based processes. Management can maintain the existing forms or create new customized forms as per business requirements.
To learn more about Pharmaceutical & Biotechnology Change Control Software Systems, please feel free to contact a MasterControl representative.