MasterControl All Access: An Appetizing Selection of Specialized Tools

There's a sweet new way to manage the multiple responsibilities quality professionals are required to handle. MasterControl All Access™ equips professionals with more than 30 specialized tools that can be used as needed. What could be more appealing than getting the software solutions you crave precisely when you need them?

All Access was designed for MasterControl customers like you who:

  • Need integrated, specialized solutions that address the many challenges you face;
  • Have difficulty convincing management to invest in expert tools that would save your company both time and money;
  • Find that it's not cost effective to invest in general purpose tools that you only use once in a while;
  • Require a complete quality management system (QMS) that handles every aspect of your job.
Document Management Process - MasterControl Documents™
Training Management and Tracking - MasterControl Training ™
Business Process Automation - MasterControl Process™

What is All Access?

MasterControl All Access is a comprehensive offering designed to work as a single solution, rather than a combination of components from multiple vendors. MasterControl recognizes that businesses have different requirements. It ensures that MasterControl customers have the exact software solutions they need, when they need them. Plus, your company will be spending less than if they had to individually purchase all the products they need from separate vendors.

All Access gives you:

  • Instant access to more than 30 MasterControl products
  • The right tool for the right job at the time you need it most
  • Flexibility to use additional new tools as your company's needs grow
  • Potential to expand to optional integrated MasterControl products
  • A vast array of services and support options

All Access puts the ultimate set of professional tools at your fingertips. Full of tantalizing solutions for today's challenges and ready to handle those that pop up in the future, All Access provides the software tools you need as your business grows and adapts to market changes.

What Do I Get With All Access?

All Access provides access to all of the following MasterControl software solutions:

Accident & Injury

Severe fines can be imposed on companies that do not report or appropriately investigate work-related accidents and injuries. MasterControl Accident/Injury™ is a dream solution that enables companies to streamline accident and injury reporting while improving compliance at the same time. The MasterControl Accident/Injury solution has been specifically designed to help companies comply with OSHA Regulation 1904 and also effectively and efficiently manage accident and injury reporting.


MasterControl Audit™, an integrated part of the MasterControl? quality suite, enables companies?especially those with large, global teams?to manage their entire audit process from planning and scheduling audits and resources to executing the audits, capturing findings offline, managing the associated findings, responses, and CAPAs, reporting on the resulting data, and create rich text final audit reports.


MasterControl BOM controls all BOM iterations generated during the design process and enables users to exchange BOM data with suppliers. Documents defining components are easily viewed from the BOM, ensuring that the right documents and revisions are used during the manufacturing process. MasterControl extracts BOM data from PDM systems and pushes it through to ERP systems automatically.


Corrective and Preventive Action (CAPA) ? the overall effort to investigate and correct quality issues to prevent recurrence ? is the crux of any quality system. It is a regulatory requirement that both FDA inspectors and ISO auditors consider singularly critical. MasterControl CAPA? is an easy-to-use software solution designed to automate and effectively manage the CAPA process and integrate it with other quality processes, such as change control, audit, training, nonconformance, and customer complaints, for a holistic quality management.


This solution automates the change control process for faster turnaround. It offers a best-practice form that incorporates priority level, as well as escalations. Real-time reports provide authorized users with the status of all change control tasks. If MasterControl Training has been purchased, any change to a document/process that warrants new training will automatically send training tasks to the e-mails of affected employees.


With this add-on to the Training module, employees can view and sign up for a class associated with their training task. Employees can view when, where, and how many seats are available for each class. Completion of a class is documented in the course and can be viewed through the training file and Analytics reports. Classes, in conjunction with Exams, will ensure you have proper documentation of your employees training.


MasterControl Customer Complaints™ provides a secure, centralized platform for receiving customer complaints and storing all documentation pertaining to a complaint's investigation and correction.


MasterControl Copies™ enables users with the appropriate rights to print controlled copies of documents. The copies are uniquely numbered, watermarked and tracked to ensure that only the most current version of a document is in circulation. The print date, document owner and location are recorded in the system to provide additional security.


Deviations may occur at any point: during sampling and testing, raw material and finished product acceptance, manufacturing, and product distribution. MasterControl Deviations automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures and specifications.

Document Collections

With MasterControl's Document Collections software solution, a bundle of documentation can be approved while all of the contents are also approved at the same time. When a component item within a document collection is revised, the full bundle has a new revision or version,


MasterControl Documents™ assigns a unique identifier to each document, and automates the routing, delivery, escalation, and approval of documents ands. The software solution can handle all types of documents regardless of the software used to create them. MasterControl features a centralized, secure repository that makes search and retrieval easy during inspections and audits. The software solution?s Web-based platform provides access to authorized users from any physical location.


The FDA's medical device reporting (MDR) regulation 21 CFR Part 803 requires device manufacturers to report to the FDA any deaths or serious injuries, as well as certain malfunctions associated with their devices. MasterControl eMDR™ enables MasterControl users to implement their FDA adverse event reporting process electronically.


MasterControl manages the calibration schedule and automatically generates calibration tasks before due dates are reached. Detailed reporting capabilities provide insight into calibration activities and help avert bottlenecks.


MasterControl manages the equipment maintenance schedule and automatically generates preventive maintenance tasks before due dates are reached. Detailed reporting capabilities provide insight into maintenance activities and help avoid bottlenecks.

Event Analyzer

Setting up tracking is a real advantage for trending when coupled with alarms that sound to notify the CAPA owner/manager of an out of trend situation. The Event Analyzer allows users to contrast and track any Quality Event and compare Quality Events to one another.


With this add-on to the Training module, your company can document your employees? competency in the course materials through an exam. Exam questions types include true/false, multiple choice, matching and others. They can be randomized so that employees receive different questions. After an employee takes an online exam, his or her exam is auto-graded and instantaneously recorded.


The MasterControl Guest Connect™ software solution allows companies to give practical interaction capabilities?notifications, task assignments, reports, etc.?to external parties such as suppliers, partners, consultants, or processors early in the development cycle without having to give them a full access account. Early involvement in document and specification creation that is provided by MasterControl's automated system can streamline a wide variety of processes.

HR Finance

MasterControl HR Finance™ routes preconfigured, electronic HR forms for electronic signature approval, and automates the delivery of notifications and follow-ups. A full set of configurable standard reports is provided; all reports can be further customized using MasterControl Analytics.


An integral part of quality management is the ability to capture quality events as a starting point for containment, corrective action, and preventive action. Examples of such defined quality events include: Nonconformances, Deviations, Variances and Customer Complaints. Other issues and observations may occur that do not fit any of these categories with the consequence of either being ignored or fed into one of these event handling systems regardless of suitability. MasterControl Incident Reporting serves as a pre-screen system to capture a wide variety of quality and non-quality events and to escalate issues to the appropriate channels.

Meeting Notes

The MasterControl Meeting Notes™ software solution serves as an aid in managing meetings of any kind by supplying Action Items that automatically tracks assigned tasks that must be completed as a result of a meeting's discussion and conclusion.


MasterControl automates data collection, routing, follow-up, and escalation of nonconformance events. The electronic ?in box? tracks all active tasks and provides tools for staying on top of things. This enables approvers to review and sign off on nonconformances electronically.

Out of Specification (OOS)

The Out-of-Specification (OOS) software solution from MasterControl automates OOS processes (including routing, notification, escalation, and approval) to help companies comply with FDA CGMPs and 21 CFR Part 211 regulatory requirements. Because the software is Web-based, employees, customers, and suppliers can participate in the forms-based OOS process from virtually anywhere.


MasterControl Process™ expedites forms-based processes, and controls the user?s ability to launch processes (based on his or her rights). This expedites processes and saves time and money, while reducing the potential for making mistakes. Configurable workflows automate routing to appropriate participants and can escalate tasks if timelines are not met. Tasks can be processed concurrently by multiple users or even groups. These features greatly speed up turnaround time.


With MasterControl Projects™, the project plan is connected to the project tasks. When a document is approved or a process is completed, MasterControl automatically updates the project plan thereby eliminating the need for manual intervention.


MasterControl Risk™ is a "one-stop shop" that unifies all risk-related activities and documentation in a single, centralized repository. The MasterControl Risk solution provides a complete and accurate picture of the risk landscape across product lines, business processes, and business units, precluding reputation damage from recalls or regulatory action.

Risk Analysis

Many of MasterControl's quality solutions include triggers for performing risk analysis. The Risk Analysis software enables a team of risk experts (designated by your company) to automatically receive information (about a deviation, for example) that triggers a risk analysis. MasterControl supplies the risk metrics, which can be further defined by your company to match specific needs. This ensures consistent, objective and defensible quality decisions.


MasterControl Rules™ enables managers to set thresholds for being notified of quality events such as customer complaints, raw material nonconformances, etc. This enables managers to receive alerts and respond immediately to (for example) a customer complaint received from 10 individuals, rather than having to wait for weekly or monthly customer complaint reports.


With MasterControl Supplier™, all supplier status and quality information (such as conforming material reports) is contained in a single, easy to access location. In addition to providing an easily maintainable AVL, the Web-based solution features a user-friendly interface for accessing all documentation and records related to each supplier.

Supplier Deviation

MasterControl Supplier Deviation™ allows a supplier to request an exception to specification before the material is shipped. This avoids the receipt of shipments that are unacceptable to the quality department and saves a great deal of time and effort on the part of everyone involved.


Documenting training is critical for any regulated company. MasterControl automates the routing, tracking, documentation, training and retraining of training tasks. Whenever there?s a change in an SOP or other document linked to a course, all affected employees automatically receive new training tasks and notification via their email. Users are provided with training materials within the training task and their competency of the material can be documented through use of an Exam add-on. Configurable training reports show pending, past due and completed training plus other critical information.


The MasterControl Variance™ software solution offers a formal mechanism for evaluating whether or not a material that fails its quality attribute specification should be accepted. The MasterControl system automatically routes requests to appropriate internal personnel to make a final decision. The rationale for decisions on variances are recorded and retained in MasterControl?s secure, centralized repository, which creates a permanent record and supports future audits and/or investigations.

Additional Products from MasterControl

Other optional MasterControl solutions can be added onto any All Access purchase. These additional MasterControl offerings are tailored for specific customers. For example, there are lines of products designed specifically for:

  • Larger enterprises that need solutions for multiple groups or sites. MasterControl provides multiple products to help enterprises efficiently implement a multi-site solution, segment the business into multiple units, optimize performance across the company's network, etc.
  • Companies that wish to connect MasterControl to other enterprise applications. For example, MasterControl supports connectors to a variety of PDM solutions in use by medical device companies and manufacturers of all types. Similarly, MasterControl provides connectors to submission-generating tools employed by pharmaceutical companies. Additionally, MasterControl has connectors to general purpose tools, such as SharePoint, scanning solutions, etc. And finally, MasterControl enables integrations with other enterprise applications, such as ERP, CRM, MES and other systems through a robust API and other integration options.

For more information about additional products that complement All Access, contact your Regional Account Executive or call (800.825.9117) or e-mail ( a MasterControl specialist.

Services and Support that Can Accompany an All Access Purchase

Data Migration Services

For companies using MasterControl's client/server system who now want to upgrade to the MasterControl web-based platform, the Professional Services team coordinates the entire migration effort. This helps maximize the benefits of new technology while minimizing disruptions to your day-to-day operations.

When employing MasterControl's Data Migration Services, all migrations are implemented using our proven project methodology. This methodology utilizes a full test migration at our facility prior to the live data migration at your site. This ensures that any data integrity issues are identified and corrected prior to the final migration of your critical data. Following a successful test at our facility, the consultant assigned to your project will repeat this comprehensive migration test plan when onsite.

Educational Services

MasterControl Inc. provides a variety of educational resources to help you gain a complete understanding of the MasterControl software suite, with the ultimate goal of improving your organization's productivity and efficiency.

Whether your needs focus on enabling a new system or building a stronger understanding of a current system, MasterControl is ready to help you meet your goals. Our Education Services Department offers a variety of instructional materials and courses designed to teach both users and administrators how to get the most from MasterControl's products.

Process Consulting and Implementation

Companies with outdated business processes can find themselves tied up in bureaucratic knots. MasterControl?s experts analyze your business processes, suggest new ways to manage them, and lead the way to automated systems that put you back in control and most importantly save you time and money. Our experts meet with your staff?typically employees in IT, quality, regulatory compliance, manufacturing and finance?to review your business flows and design better ways to accomplish organizational goals.

Integration Services

In addition to using MasterControl software to automate internal processes, companies frequently deploy a variety of other third-party software applications as well. Examples may include enterprise resource planning (ERP), customer resource management (CRM), clinical trial management system (CTMS), manufacturing execution systems (MES), and product data management (PDM) applications. You?ll be happy to know that MasterControl integrates nicely with many major software applications typically used by our customers. In some cases there are many connection points between MasterControl?s system functionality and the functionality of other applications. When properly configured, these connection points can vastly improve the overall performance and automation of your entire company. The MasterControl Connections Toolkit enables companies to bridge that functionality by integrating MasterControl products with third party systems.

Project Management Services

MasterControl offers Project Management Services to help alleviate the challenges of project management and ensure successful implementation of your new software. Through this service, MasterControl will provide the continuity and quality that you need throughout the deployment process. An experienced MasterControl project manager will provide management expertise, serve as a project champion, coordinate activities, and communicate critical milestones. This provides a single-point of accountability and communication for the entire project.

Technical Support Services

Even the most proficient users of MasterControl occasionally have questions about its specific features, functions or benefits. Technical support is the service provided by MasterControl to answer questions and provide solutions to customers using the software. MasterControl maintains several levels of support, ranging from online self-help via the customer website to one-on-one, in-person assistance. Our goal is to provide 100% customer satisfaction. The technical support program includes the Self-Service Web Portal (, Maintenance Support Service, IT Training, MasterControl Installation and Custom Support Options. MasterControl products are supported according to several time-based phases: Mainstream Support, Extended Support and Ongoing Support.

Validation Services and Solutions

Our team of highly skilled experts has a wide range of industry backgrounds and collective experience performing software validation. Whether you are looking for a completely outsourced model, formal training, or just a little advice to assist your internal efforts, our team of seasoned professionals will help you meet today?s regulatory requirements and complete your systems process compliance.

Due to constraints in resources, deadlines, or internal priorities, many MasterControl customers request an outsourced model to help with their validation requirements. MasterControl stands ready to assist with this effort at all levels including project assessment and planning, project management, executing protocols, systems audits, conducting third-party reviews, and more. And since we communicate with you frequently throughout the entire validation process you can rest assured that problems are being addressed and that the entire project is moving forward as efficiently as possible.

Configuration Services

MasterControl's Upgrade Configuration Services will assist current MasterControl customers by providing the necessary knowledge and skills to quickly update, configure, train and plan the required validation and project activities needed to implement the newly upgraded features of the MasterControl system.

About MasterControl

MasterControl Inc. produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company?s critical information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the entire enterprise.