MasterControl Advanced Packet Types - Change Control Software System

MasterControl Advanced Packet Types - Change Control Software Systems are Specially Designed for Automating Advanced Change Control Processes

The only constant in life, business, and quality management is change. In FDA and ISO environments in particular, effective change control management is required as a way of improving product quality and safety - and ensuring compliance.

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MasterControl Change Control

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Hunderte von Unternehmen weltweit nutzen MasterControl zur Automatisierung zentraler Unternehmensprozesse und Dokumentenmanagement-Aufgaben, um die Zusammenarbeit zu fördern, die Entscheidungsfindung zu verbessern und die Markteinführung zu beschleunigen.

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Demo: MasterControl Change Control Software

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Demo: MasterControl Document Control Software

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How a Pharma Company Manages Change Control

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How a Pharma Company Uses MasterControl Document ControlÖ and CollaborationÖ

How a Pharma Company Uses MasterControl Document Control™ and Collaboration™

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MasterControl Change Control MasterControl Documents™
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Übersicht über das MasterControl Qualitäts-Management-System (QMS)
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Änderungssteuerung – Kontinuierliche Qualitätsverbesserung in FDA- und ISO-Umgebungen Managing Change Control to Comply with FDA and EU Regulations Automating Electronic Engineering Change

How Can the MasterControl Advanced Packet Types Change Control Software Help You?

MasterControl Advanced Packet Types™ is a software solution designed to automate and effectively manage every step of the change control process, from initiation through actual implementation, verification, and completion of a project. MasterControl has the ability to create multiple change packet types that can be used to greatly streamline complex change control processes. Using MasterControl, new packet types can be configured with both custom and preconfigured fields to automatically capture data pertinent to change control activities. The integrated MasterControl solution also helps prevent the use of incorrect components in manufacturing due to insufficient disposition data on an engineering change order (ECO) that may otherwise result in rework or scrap.

Here’s how companies can use MasterControl to resolve major change control challenges:

Change Control Challenges	MasterControl Advanced Packet Types Change Control Solution
Disconnected Change Control Processes Communication breakdown is likely to happen in a quality management system that consists of disconnected tools and processes. In the context of change control, this could mean lack of visibility and follow-up, late notifications, and delays in task completion. Change information is often dispersed and difficult to compile in a logical manner. In worst case scenarios, recalls cannot be bracketed because there is an inability to compile a proper change history.	Connected Change Control Processes MasterControl is an integrated solution that effectively connects users, data, and processes under a centralized system. This connectivity vastly improves communication and efficiency, and helps ensure that issues don’t fall through the cracks. MasterControl provides visibility into upcoming changes and prevents material disposition information from being incomplete or going missing.
Poor Change Control Turnaround Timeliness is essential in change control. A manual system that relies on paper-based documents to generate necessary data, and legwork to route and track submissions is likely to have poor turnaround for change implementation.	Excellent Change Control Turnaround Cycles MasterControl integrates and streamlines the entire change control process for faster turnaround. An easy-to-use graphical workflow designer that incorporates escalation steps allows users to build simple and complex change processes effortlessly. Plus, reports provide real-time status for all change control tasks.
Training not Integrated with Change Control In a manual system, it is difficult for employees to keep up with all the changes in ECNs, ECOs, SOPs, policies, and other critical documentation because the training process is not connected to the rest of the quality system.	Integrated Training With MasterControl, the change control process is integrated with training management. Any change to a document/process that warrants new training will automatically trigger training tasks based upon training requirements set during the change control process. In cases where training is not warranted, justification must be provided as to why.

Change Control Challenges

MasterControl Advanced Packet Types Change Control Solution

Disconnected Change Control Processes

Communication breakdown is likely to happen in a quality management system that consists of disconnected tools and processes. In the context of change control, this could mean lack of visibility and follow-up, late notifications, and delays in task completion. Change information is often dispersed and difficult to compile in a logical manner. In worst case scenarios, recalls cannot be bracketed because there is an inability to compile a proper change history.

Connected Change Control Processes

MasterControl is an integrated solution that effectively connects users, data, and processes under a centralized system. This connectivity vastly improves communication and efficiency, and helps ensure that issues don’t fall through the cracks. MasterControl provides visibility into upcoming changes and prevents material disposition information from being incomplete or going missing.

Poor Change Control Turnaround

Timeliness is essential in change control. A manual system that relies on paper-based documents to generate necessary data, and legwork to route and track submissions is likely to have poor turnaround for change implementation.

Excellent Change Control Turnaround Cycles

MasterControl integrates and streamlines the entire change control process for faster turnaround. An easy-to-use graphical workflow designer that incorporates escalation steps allows users to build simple and complex change processes effortlessly. Plus, reports provide real-time status for all change control tasks.

Training not Integrated with Change Control

In a manual system, it is difficult for employees to keep up with all the changes in ECNs, ECOs, SOPs, policies, and other critical documentation because the training process is not connected to the rest of the quality system.

Integrated Training

With MasterControl, the change control process is integrated with training management. Any change to a document/process that warrants new training will automatically trigger training tasks based upon training requirements set during the change control process. In cases where training is not warranted, justification must be provided as to why.

Features and Benefits of MasterControl Advanced Packet Types of Change Control System:

Complete Solution: MasterControl offers robust software that ensures all the change information you need is located in one convenient location. Change information is automatically populated as changes are made to make certain that an accurate and complete record is maintained and that the time required to assemble and route a change packet is reduced.
Highly Configurable Change Forms: Configurable, multi-page forms help collect and track data throughout the change control process. Change control forms can be configured to include as much or as little information as is required.
A section in the change submission form captures such information as description of change, justification, and impact. Document redlines showing changes are easily accessed throughout the change process.
An initiator can use one 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 initiator is asked to evaluate the change in terms of training, validation, and regulatory requirements, prompting risk assessment. Any case where information is not required (e.g., validation) a justification is required and supporting documentation such as engineering analyses may be attached to the change packet.
Revision history is automatically compiled for each item included in a change packet, showing a description of changes and effective date for each revision. Document authors no longer have to worry about updating the revision history table in each document as changes occur.
Task Automation: MasterControl automates all tasks pertaining to change control, including routing, notification, follow-up, escalation, and approval. Automation helps simplify the compliance environment, making it easier to maintain compliance.
Integration: MasterControl allows users to access change information directly from a document. Items on any given ECO are automatically linked to the ECO form for easy access. The MasterControl system also automatically generates a revision history for every document.
Flexibility: MasterControl makes certain that your change process is only as complex as it needs to be. With MasterControl one size doesn’t have to fit all — users can create multiple change types for varying degrees of complexity. Change workflows can include a step for approval by a change review board prior to having the changes implemented.
Revision Control: With MasterControl, it is easy to identify documents that are under revision, even if the user doesn’t have rights to draft documents. These users see an indication that the document is under revision, but cannot see the draft document itself. MasterControl provides automatic revision history through the InfoCard, the MasterControl tool that summarizes basic information for every record. All changes made to the InfoCard are tracked, including reason(s) for every change.
Analytics and Reporting: Provides standard and customized reports. Data can be summarized in multiple levels, so change orders can be reported by product, department, root cause, etc. MasterControl’s advanced analytics and reporting capability includes dashboard, drill-down, and scheduling features.
Compliant System: MasterControl facilitates continuous compliance by keeping your quality system ready for inspections and audits at all times.
Part 11-Compliant Features: MasterControl provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy the FDA's 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.
Web-based Platform: MasterControl is Web-based so it connects all users involved in change control from virtually anywhere. Individuals throughout the organization can be involved in the change process in an easy-to-use Web-based environment.
Training Integration: MasterControl integrates the change control process with training management. Any change to a document or process that calls for new training will automatically invoke training tasks. The system automates the process of distributing online exams and grading.
Integrates with Existing Repositories: Integrates with existing document repositories and enterprise applications like ERP, LIMS, etc., without expensive custom coding.
Continuous Validation: For companies doing business in regulatory environments, MasterControl offers a continuous validation approach that dramatically cuts the time, pain, and cost involved in validation. MasterControl's continuum of innovative products and services include MasterControl Transfer OQ.
Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer’s needs, from initial installation to regular maintenance.

QMS-Anbieter für die FDA

MasterControl Inc. und sein Partnerunternehmen i4DM erweitern ihr FDA-Projekt und wollen als QMS-Anbieter für einen zweiten FDA-Bereich fungieren. Die beiden Unternehmen sind seit 2009 als QMS-Anbieter für das Office of Regulatory Affairs der FDA tätig und möchten nun auch als Qualitätsanbieter für die Division of Pharmaceutical Analysis fungieren, die Teil des Center for Drug Evaluation and Research der FDA ist.

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