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Change Control Software Systems

In FDA-regulated and ISO-certified environments, companies are expected to establish procedures for effective change control software systems in order to ensure product quality and safety. Regulated and ISO companies are also expected to maintain detailed documentation on all changes that are made in a change control software.

Given the multitude of ongoing processes for document change (design specs, formulations, SOPs, specifications for raw materials, etc.), automated change control systems are critical. Not only can software for change management assure compliance, it can also greatly enhance a company's productivity.


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Produktinformationen

Discover how MasterControl Change Control Software Systems can manage your Change Control process, all while mitigating risk, improving speed-to-market, and generating ROI.

Produktdatenblätter
Produktdatenblätter
  • Die Einhaltung behördlicher Vorschriften erfordert die Zusammenarbeit auf allen Ebenen eines Unternehmens. Durch die Automatisierung, Vereinfachung und Optimierung der Zusammenarbeit an dokumentenbasierten Projekten ermöglicht MasterControl Collaboration™ Mitarbeitern in einem Unternehmen einen effizienten Wissensaustausch.
  • Die Softwarelösung MasterControl Documents™ sorgt für die Automatisierung und effiziente Verwaltung des Dokumentenlenkungsprozesses, um Unternehmen bei der Einhaltung behördlicher Vorschriften zu unterstützten. Sie automatisiert sämtliche Weiterleitungs-, Übermittlungs-, Eskalations- und Genehmigungsprozesse für Dokumente und erleichtert das Suchen nach und Abrufen von Dokumenten bei Audits und Inspektionen.
  • Die Einhaltung behördlicher Vorschriften erfordert die Zusammenarbeit auf allen Ebenen eines Unternehmens. Durch die Automatisierung, Vereinfachung und Optimierung der Zusammenarbeit an dokumentenbasierten Projekten ermöglicht MasterControl Collaboration™ Mitarbeitern in einem Unternehmen einen effizienten Wissensaustausch.

Demos & Toolkits

Get in-depth, comprehensive resources to guide development of your Change Control program

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Interaktive und Live-Demonstrationen
  • Das Qualitätsmanagementsystem (QMS) von MasterControl bietet eine breite Palette an Softwarelösungen für Qualitätsmanagement, Dokumentenlenkung, Produktlebenszyklusmanagement, Lieferantenmanagement, Auditmanagement, Schulungsmanagement und weitere, auf Ihre Unternehmensbedürfnisse abgestimmten Lösungen. Dieser Überblick zeigt, wie Sie mit dem QMS von MasterControl Abfall vermeiden, Audits vereinfachen und die Einhaltung behördlicher Vorschriften erleichtern.
Produktdatenblätter
Toolkits
  • Die Experten von MasterControl haben mehr als 300 Stunden in die Entwicklung dieses Dokumentenlenkungs-Toolkits investiert. Dieses bietet alle Ressourcen, die Unternehmen für die Einrichtung eines optimierten und robusten Dokumentenmanagementsystems benötigen. Umfasst 3 Videos, 3 Whitepaper, 2 Datenblätter und 1 interaktive Grafik.

Educational Materials

Get insider information about the most relevant issues in Change Control Software Systems today, and how to navigate and overcome the complexities of FDA and ISO compliance.

Produktdatenblätter
White Paper
  • Gleicht Ihr Dokumentenlenkungsprozess einem Hindernislauf auf dem Weg zur erfolgreichen Produkteinführung? Das muss nicht so sein. In diesem Whitepaper werden die häufigsten Probleme in allen fünf Stadien des Dokumentenlenkungsprozesses erläutert. Zudem enthält es Tipps, wie diese Probleme behoben werden können. Dabei greift der Autor auf Erfahrungen aus dem echten Leben zurück, die er selbst in über zehn Jahren gesammelt hat.
Educational Materials
E-Book
  • Seit dem Jahr 2000 profitieren wir in Bezug auf regulatorische Compliance von unserem technologiegetriebenen Zeitalter. Dieses E-Book führt 16 Gesetze und Initiativen auf, die die Modernisierung mit vorangetrieben haben. Es ergründet, wie sowohl Aufsicht unterliegende Unternehmen als auch Regulierungsbehörden im vergangenen Jahrzehnt durch die Nutzung von Technologie Compliance vereinfachen und damit verbundene Kosten senken konnten.


How can MasterControl Change Control Software Systems Benefit You?


MasterControl change control software is designed to help manufacturers automate and effectively manage every step of the change control process, from submission through actual implementation, verification, and close of project. Here's how MasterControl can ease some of the major challenges with your current change control system.

Change Control System Challenges

MasterControl Change Control Software Solution


Disconnected Change Control System Processes

Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage the quality system. In the context of change control system, this could mean lack of follow-up, late notifications, and tasks not completed by deadline. Suppliers could be making changes without proper and timely notification.


Connected Change Control Software

MasterControl is an integrated change control software that connects different departments with data and processes under a secure and centralized system. This connectivity vastly improves efficiency through automatic task assignment, routing, scheduling, notification, and escalation of incomplete tasks. MasterControl is Web-based, so 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.


Poor Change Control Turn-Around

Timelines are essential in change control systems. A manual system that relies on paper-based documents to generate necessary data and old-fashioned legwork to route and track submissions and change orders is likely to have poor turn-around for change. implementation.

Excellent Turn-Around with a Change Control System

MasterControl integrates and streamlines the entire change control system procedures for 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, reports provide real-time status for all change control tasks.


Training not Integrated with Change Control Software

In a manual system, it is difficult for employees to keep up with all the changes in SOPs, policies, and other critical documentation because the training process is not connected to the rest of the quality system for which MasterControl's Change control software was introducted.

Integrated Training System with Change Control System

With MasterControl, the change control software can be integrated with the training application. Any change to a document that warrants new training will automatically invoke training tasks. MasterControl can automate the process of distributing online exams with the training, and even includes automatic grading.


Change Control Software System Best Practice Form

The change control software system from MasterControl offers a pre-configured, multi-page best-practice form for collecting and tracking data throughout the entire change control process.

  • A section in the change form captures information such as: description of change, justification, and impact. Both original and revised documents can be attached for easy comparison.
  • The initiator of the change can use the same form for multiple changes. For example, the form for a change in a component used in making 10 products can have 10 attachments, greatly streamlining the process.
  • The change control software prompts the initiator to evaluate the change in terms of training requirements, validation, and regulatory requirements prompting risk assessment.
  • The initiator is also asked to classify the change as low, medium, and high. Any high-level change implies great impact on the product and is likely to require regulatory filing.
  • In addition, the change control software system prompts the initiator to categorize the change as routine, temporary or emergency. (A high-level change usually implies great impact on the product and is likely to require regulatory filing.)
  • The form for change management can be customized to meet any unique requirements.

Additional Change Control Software System Features

Other important features provided by the change control software system from MasterControl are outlined below.


Form-to-Form Launching – A change submission form can be launched directly from a Corrective/Preventive Action (CAPA) form, connecting one process to the next. MasterControl streamlines this process and maintains the links, making it easy to see what triggered the change. Relevant information from the CAPA form will be automatically entered into the change submission form, reducing data entry. It also shows the history of the entire process.


Document Approval via Forms – With the change control software from MasterControl, the change submission form and the documents linked to it can be approved all at once, avoiding repetitive steps.


Dependent Routing – Completion of a task can be made dependent on another task to give managers more control and reduce cycle time (by prompting users immediately to begin their next task). An innovative dependency tree graphically illustrates the relationships between dependent processes.


Der im Aufbau mit dem Windows-Explorer vergleichbare MasterControl-Organizer ist ein benutzerfreundliches Tool zum Suchen und Abrufen von Dokumenten.Alle zu einer bestimmten Änderung gehörenden Arbeitsanweisungen und sonstigen Dokumente können in einer Gruppe zusammengefasst werden. Die Benutzer können virtuelle Ordner in Organizern erstellen, in denen Dokumente auf der Basis vorab definierter Abfragen automatisch abgerufen werden.


Powerful Reporting Tool – The change control software system can group data together by time interval, then chart the data for a specified range of dates. 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 at multiple levels, so that change orders can be reported on by product, department, root cause, etc.