MasterControl Change Order Software Helps You Protect Your Customers and Bottom Line
In the manufacturing environment, change refers to any modification in materials, facilities, utilities, product design, formulations, processes, packing/labeling, equipment, computer systems, as well as all associated documentation (SOPs, test methods, quality manual, etc.). A change order software system may be called upon to handle a relatively minor adjustment, such as a part replacement, or it may be expected to address an issue that is serious enough to shut down production. In a large or growing company, it would be very difficult, if not impossible, to manage change and demonstrate compliance without an enterprise-wide change order system.
Auch wenn die regulatorischen Anforderungen an Änderungssteuerung von Branche zu Branche unterschiedlich sind, ist die Grundrichtung aller Vorschriften die Verpflichtung, sämtliche Änderungen gemäß den genehmigten und schriftlich fixierten Richtlinien und Verfahren des Unternehmens vorzunehmen. Dies hat zwei Gründe: Eine schriftliche Fixierung von Richtlinien ermöglicht die Standardisierung von Verfahren und ist außerdem zuverlässiger als die verbale Weitergabe von Informationen. Darüber hinaus haben Unternehmen damit die Möglichkeit, alle Änderungen, die mit einem bestimmten geänderten Element oder einer geänderten Entität zusammenhängen, zu protokollieren, was unerlässlich für Auditzwecke ist.
MasterControl's change order software is robust and flexible enough to manage all types of change requests that could affect the safety and reliability of products and directly impact public health and safety. And because even the smallest change can make a big difference in your bottom line, an effective change order system is essential if your organization hopes to remain profitable and competitive.
Tackle the Most Critical Change Control Challenges with MasterControl Change Order Software
While an electronic change control system is necessary to prevent the occurrence of inappropriate or "uncontrolled" change, which in this context refers to modifications made without the proper review and approval of the quality control unit and other departments impacted by the change, implementing and maintain one can be quite complex. Fortunately, MasterControl's change order software system was designed to handle these challenges quickly and efficiently. Here's how:
- Communication Challenges:Communication breakdown is a likely outcome in companies that rely on disconnected or paper-based tools and face-to-face information exchanges to manage change. Whether the breakdown manifests itself in lack of follow-up, task completion delays, or simply the relaying of erroneous or incomplete information, it increases your risk of noncompliance. MasterControl Solution: MasterControl is an integrated solution, connecting users, data, and processes under a centralized system, so it vastly improves communication through automatic task assignment, routing, scheduling, notification, and escalation of overdue tasks. And because MasterControl change order software system is Web-based, third-party suppliers and off-site employees are able to participate in the change control by tracking, reviewing, and approving changes from virtually anywhere.
- Turnaround Challenges: When change issues surface, the faster they can be resolved, the better. The legwork required to route and track manual change submissions can slow down the process significantly. MasterControl Solution: MasterControl streamlines the entire change control process, resulting in faster turnaround. It offers a pre-configured, multi-page best-practice form that enables you to collect and track data from submission through project close. The form allows the initiator to assign a priority level (routine, temporary, or emergency) and provides real-time status reports for all change control tasks.
- Documentation and Training Challenges: When the training process is siloed outside the change order system, as it is in a typical paper-based system, changes in SOPs, policies, and other documents often fall through the cracks. MasterControl Solution: MasterControl change order software seamlessly incorporates training into the change control process. When a document change or process change warrants new training, tasks are automatically assigned upon approval of the change.
Additional Advantages of MasterControl's Change Order Software System
An Organizer Tool for Easy Document Search and Retrieval: Similar to Windows Explorer, MasterControl's Organizer allows you to quickly and easily find and retrieve documents. Organizers also allow you to group together SOPs and other documentation related to a particular change. What's more, within Organizers, users are able to create virtual folders, which allows for the retrieval of documents based on pre-defined queries.
Part 11-Compliant Features: MasterControl change order software provides a time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA's 21 CFR Part 11 requirements. The identity of anyone who creates or modifies an electronic record is tracked in the audit trail, as well as when and what changes were made. Robust security features, such as dual passwords for document approval; password expiration, encryption, and certification; and account lockout, prohibit users without proper authorization for gaining access to the system.
Continuous Validation: Validation is a critical component of any change order software system. MasterControl offers a wide range of validation products and services, such as MasterControl Transfer OQ and MasterControl Automated OQ. These products and services are designed to meet various need levels based on risk, and offer "continuous validation" to FDA-regulated companies. The bottom line: Continuous validation dramatically makes software upgrades easier, faster, and more cost-effective.
For More Information on MasterControl's Change Order Software
For more information about MasterControl's change order software system, and how MasterControl can help your company, please feel free to contact a MasterControl representative.