MasterControl Software Systems for Medical Device Companies:

MasterControl DHF Jumpstart™
MasterControl DHF JumpStart is a tool for medical device developers who work in small- to medium-sized companies. It’s a preconfigured document control database that helps device developers swiftly organize their work so they spend less time with administrative duties and more time in development. The software provides multiple simple routes for collaboration, approval, and review and is an affordable solution for companies who want some customization in their document control process.

MasterControl DHF Express™
MasterControl DHF Express provides a solution for collecting, organizing, and reviewing all the documents required to meet FDA requirements. The software is specifically created for automating the design control process at a price affordable for startup and small-sized medical device companies.

MasterControl CAPA MD™
MasterControl CAPA MD 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 approach to quality management.

MasterControl Customer Complaint MD™
MasterControl Customer Complaint MD is a complete solution that automates complaint handling, integrates it with the quality system, and manages complaint resolution swiftly and effectively. Complaint data is instantly available to quality and regulatory specialists as well as development engineers for evaluation, so product review and redesign may commence immediately, if necessary. This is a tremendous advantage in today's litigious society, when slow response to customer complaints can land a manufacturer in the courtroom.

White Papers Specifically for Medical Device Companies:

White Paper: Reducing the Documentation Burden in FDA Design Control
It is not uncommon for a single medical device to generate hundreds of pages of documentation to demonstrate design control compliance. Engineers must design, develop, and test new medical devices, and at the same time ensure that all of the necessary documentation is in place to demonstrate FDA compliance with design controls.

This white paper discusses ways to reduce your documentation burden and covers the following:

Q&A: Compliance with ISO 13485 and 21 CFR Part 820 for Med Device Companies
Whether it's a simple thermometer or a sophisticated cardiac pacemaker, the goal of FDA's 21 CFR Part 820 and ISO 13485 international standard is to ensure medical device quality and safety and to reduce, if not prevent, injuries and deaths.21 CFR Part 820 outlines Quality System Regulations (QSR) for medical device manufacturers and importers. ISO 13485, a voluntary quality standard, provides a framework for meeting medical-device quality requirements in the international market.

Q&A: CDRH / ORA Investigator Offers Insights on Medical Device Inspections
From contact lenses to thermometers to artificial hips, chances are every American has used a medical device at some point. More than 20,000 companies worldwide manufacture over 80,000 brands and models of medical devices for the U.S. market. This question-and-answer white paper addresses the following:

Q&A: ISO 14971 Medical Device Risk Management
ISO 14971 Medical Device Risk Management, Risk management is more than just a buzzword in the medical device industry. It's considered essential — both by ISO and FDA — in ensuring the safety and reliability of medical devices. ISO 14971:2000 (Medical Devices – Application of Risk Management to Medical Devices) is an international standard used by manufacturers as a tool for conducting risk assessment. The FDA recognizes it as an acceptable risk management model and the European Union has made it mandatory.

White Paper: Does Your CAPA System Need a CAPA?
The FDA requires establishment of a corrective/preventive action (CAPA) process to help improve product quality and safety. For manufacturers, the CAPA process also helps the bottom line by preventing product returns, rework, and recalls. But establishing a CAPA system that works and at the same time keeps compliance cost down is a major challenge for most companies.

White Paper: How to Kick-Start Your CAPA Process
"How to Kick-Start Your CAPA Process," an industry white paper offered by MasterControl Inc. and PathWise Inc., describes a time-tested method using deductive reasoning and comparative analysis to help organizations get to the root causes of nonconformance, deviations, out of specifications, customer complaints, and other factors that can lead to corrective action.

White Paper: 21 CFR Part 11 Industry Overview: Ready for an FDA inspection?
21 CFR Part 11 Industry Overview: Ready for an 21 CFR Part 11, how the regulation is affecting life sciences companies, and how they can improve their compliance programs and always be prepared for an FDA inspection.

White Paper: Automating Electronic Engineering Change
Every manufacturer needs an engineering change order (ECO) process for initiating and controlling any modifications in a drawing, part, process, or equipment. The ECO process is crucial in ensuring high quality, safety, and consistency of products. For this reason, ECO is key to compliance In the FDA and ISO environments.

White Paper: Five Ways MasterControl Ensures System Compliance with 21 CFR Part 11
It is often said that it is not quality, but the lack of it, that costs a lot of money. This is especially true in the strict FDA and ISO environments. This white paper suggests that an optimal quality management system, as a foundation for FDA and ISO compliance, will help you avoid the high cost of poor quality. Prepared by MasterControl Inc., this white paper offers six practical tips for optimizing your quality management system, ranging from automation of quality processes to utilizing training as a tool for continuous quality improvement.

Other MasterControl Software Systems:

MasterControl Documents™
MasterControl Documents helps increase the quality unit's efficiency and effectiveness by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation, making search and retrieval easy. MasterControl Documents, the core application in the MasterControl quality management suite, integrates all quality processes such as change control, customer complaints, corrective/preventive action, audits, etc., for a closed-loop solution.

MasterControl CAPA™
The MasterControl CAPA system interconnects different quality subsystems and tracks incidents that can escalate into a corrective action. It includes a best-practice "8D" process to guide the quality team through every step of CAPA implementation, from identification of the problem through corrective action. A CAPA form can be launched directly from another form (e.g., nonconformance or deviation report), automatically entering relevant data into the CAPA form, reducing data entry and eliminating errors from manual transfer of information. Through the Internet, customers, vendors, and others outside the company can submit customer complaint or other forms that could lead to CAPA.

MasterControl Change Control™
MasterControl Change Control streamlines the entire change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change implies great impact on the product and is likely to require regulatory filing. Customizable reports provide real-time status not only of change control tasks but of the entire quality system.

MasterControl Training™
MasterControl Training automates assignment and monitoring of training tasks and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed; the next one is automatically launched. Provides group sign-off feature for verifying training of large groups of employees. Training management can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.

MasterControl Nonconformance™
MasterControl Nonconformance is a robust solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. The solution's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance. This solution offers the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrants it. Training will automatically invoke training tasks upon approval of the change.

MasterControl Audit™
MasterControl Audit automates, streamlines, and effectively manages the audit process. It provides advanced tracking capability, from scheduling and planning to execution and completion. MasterControl offers best-practice forms for tracking basic audit information and audit findings. It automates scheduling of all recurring audit-related activities and provides advanced analytics and reporting capability, so managers get a real-time view of the audit process.

MasterControl Customer Complaints™
MasterControl Customer Complaints streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with a resolution of the issue. MasterControl's advanced reporting capabilities increase management oversight and demonstrate appropriate controls to regulatory agencies. MasterControl is Web-based, so customers can submit complaints from virtually anywhere.

MasterControl Forms™
MasterControl Forms automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. This solution offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Forms created in Microsoft Word, Excel, or PowerPoint can be converted to PDF as is, so users will see the same form and won't need new training. A company may also improve existing forms or designs new ones to suit its needs.

MasterControl Submissions Gateway™
MasterControl Submissions Gateway™ facilitates electronic delivery of FDA applications (such as IND, NDA, and BLA) by providing control in assembling and tracking necessary documentation. It provides appropriate templates to streamline the dossier-creation process. MasterControl can be integrated with leading e-submission applications, connecting approved documents and forms-based content with the dossier assembly process, to accelerate submissions.

MasterControl SOX™
For companies seeking compliance with the Sarbanes-Oxley Act, MasterControl SOX is a complete and easy-to-use solution that automates and effectively manages business processes, including voluminous documents, records, and SOPs. It includes a pre-configured form that documents and collects data pertaining to risks, internal controls, and tests. It links every risk with its control and test through pre-built workflows. It allows testing to be automatically scheduled and incorporates escalation to ensure that tests are completed.

MasterControl Enterprise™
MasterControl Enterprise a part of the MasterControl integrated quality management suite, provides powerful filtering capability that allows individual business units to manage certain aspects of their processes independently.

MasterControl Rules™
MasterControl Rules, a part of the MasterControl integrated quality management suite, is a configurable and easy-to-use solution for effective monitoring and management of critical quality events and tasks. It also empowers individual users to manage their own tasks more efficiently and effectively.

MasterControl Projects™
MasterControl Projects automates the process of controlling projects, particularly those that are document and/or process-based. It automates task assignment, routing, escalation, and tracking. It streamlines the workflow and provides project transparency that fosters accountability.

MasterControl Document Connections™
MasterControl Document Connections allows companies to integrate their existing electronic repositories ECM, PLM, or other types — with MasterControl Training™, MasterControl CAPA™, MasterControl Forms™, and other cutting-edge MasterControl applications. By using this module, integration of MasterControl solutions with external repositories can be made easily and immediately, without expensive custom coding.

MasterControl Toolkit™
MasterControl Toolkit allows companies to integrate MasterControl's robust quality management solutions with other enterprise applications to optimize operations. The toolkit enables the exchange of files and data between MasterControl and other software applications.

MasterControl Transfer OQ™
MasterControl Transfer OQ (TOQ) is a key part of MasterControl's continuous validation approach. Based on a company's corporate policy and risk assessment, it may choose to assimilate or "transfer" OQ documentation as part of its overall validation effort, saving both time and money.

MasterControl Electronic Batch Records™
MasterControl Electronic Batch Records is designed based on the Instrumentation, Systems and Automation Society's S88 model (ISA-S88 or S88), is a powerful EBR management solution for automating and controlling batch processes.

MasterControl CAPA Pharma™
MasterControl CAPA Pharma is a complete solution designed to help pharmaceutical companies automate and effectively manage the CAPA process and integrate it with their quality processes, such as change control, audit, training, nonconformance, and customer complaints. It allows staff to file all forms in one place, for easy review and retrieval.

MasterControl Customer Complaint Pharma™
MasterControl Customer Complaint Pharma is a complete solution that automates complaint handling, integrates it with the quality system, and manages complaint resolution swiftly and effectively. Complaint data is instantly available to quality and regulatory specialists as well as product engineers for evaluation, so product review and redesign may commence immediately, if necessary. This offers a tremendous advantage in preserving a company's reputation from legal entanglements that may arise from unhappy customers seeking reprisal, whether warranted or not.

MasterControl GCPDocs Express™
MasterControl GCPDocs Express provides a solution for collecting, organizing, and reviewing all the documents required to meet the GCP requirements. It is specifically designed to help organize and control nonclinical, clinical, and regulatory documents for smaller pharmaceutical and biotechnology companies. It helps take the "complicated" out of the burdensome paperwork requirements.

MasterControl Electronic GCPDocs JumpStart™
MasterControl GCPDocs JumpStart provides a solution for collecting, organizing, and reviewing all the documents required to meet the GCP requirements. It is specifically preconfigured according to regulatory standards and industry best practices to help organize and control nonclinical, clinical, and regulatory documents to meet NDA document requirement needs for growing pharmaceutical and biotechnology companies. The software provides multiple simple routes for document collaboration, approval, and review. It's an affordable solution for companies who want to automate their document control process.

Other White Papers / Q&A Descriptions:

White Paper: 21 CFR Part 11 Product Positioning
21 CFR Part 11 Product Positioning, in 1998, MasterControl Inc. introduced the first quality management software especially designed to help the life sciences industry comply with Part 11. This white paper provides a table that shows how MasterControl addresses major Part 11 requirements.

White Paper: 21 CFR Part 11 Risk of Non-Compliance
The FDA is re-examining 21 CFR Part 11, the regulation that made electronic records and signatures as valid as paper records and handwritten signatures in regulatory submissions. The focus of this scrutiny is the scope of 21 CFR Part 11's interpretations.

White Paper: 21 CFR Part 11 System Validation (Risk Management Plan)
This article discusses the concept of computer software validation in relation to 21 CFR Part 11. The FDA requires computer systems validation through a development lifecycle containing strict guidelines with concept, user, and functional requirements.

White Paper: Automating Training Control Processes
Automating Training Control Processes. , While most companies agree that training needs to be a continuous process, their main stumbling block remains training control, especially if they rely on a paper-based or hybrid system. How do you track, document, and manage the process? How do you know who needs what training when? Who's training whom? Who passed or failed which training? If these things sound familiar, then this white paper is for you. It discusses the following:

White Paper: Automating Document Control Processes
Document control is critical in making sure that production processes and methods are all pre-approved and that any change in these processes are restricted to authorized personnel and tracked for future review. Despite the underlying importance of document control, many companies continue to rely on paper-based and partially electronic document control systems that are plagued by inefficiency and errors that could cause Form 483 citations. Automating a paper-based document control process may be challenging, but it ultimately helps eliminate common errors that could lead to Form 483 citations.

White Paper: Change Control-Quality Improvements in FDA and ISO Environments
For FDA-regulated and ISO-certified companies, effective handling of customer complaints is not just a matter of good business practice but compliance. This white paper, prepared by MasterControl Inc., discusses the deeper implications of consumer complaints in the FDA and ISO environments and how companies can turn complaints into opportunities for quality improvement.

White Paper: Sarbanes Oxley Compliance-Challenges and Solutions for Sustained Compliance Achieving Quality Across the Global Manufacturing Network
The Sarbanes-Oxley Act (SOX), which affects thousands of public companies in the United States, has changed the landscape of regulatory compliance. For the first time, regulatory noncompliance means personal criminal liability — steep fines and imprisonment for responsible executives. Under Sarbanes-Oxley, the level of scrutiny is also more extensive, affecting a wide range of a public company's day-to-day activities. And more than any other regulation, Sarbanes-Oxley requires organizations to maintain a constant state of audit-preparedness.

White Paper: Quality Audit- A tool For Continuous Improvement and Compliance
Many people dread audits because they see it as adversarial. The fact that the audit process casts auditors on one side and auditees on the opposite side creates a general impression that an audit is inherently negative. This white paper prepared by MasterControl shows that audits and audit management do not have to be a negative experience. When implemented properly, audit management can be one of the most effective means for improvement. More and more FDA-regulated and ISO-certified companies use audit as a management, compliance, and quality tool.

White Paper: Standard Operating Procedure SOP Management as a Compliance Tool in FDA and ISO Environments
Most companies need standard operating procedures (SOPs) for a variety of reasons. SOPs can be simple or complex, but they usually describe a procedure and instruct an operator how to perform it. While most organizations need SOPs for business reasons, FDA-regulated and ISO-certified companies need them for compliance as well. This white paper, prepared by MasterControl Inc., discusses why SOPs are more than just a tool of operation. Once established, an efficient and effective SOP management system will serve as a foundation for an organization's sustainable compliance and long-term success in the market.
This white paper covers the following:

White Paper: Complaint Handling as an Integral Part of FDA and ISO Compliance
For FDA-regulated and ISO-certified companies, effective handling of customer complaints is not just a matter of good business practice but compliance. This white paper, prepared by MasterControl Inc., discusses the deeper implications of consumer complaints in the FDA and ISO environments and how companies can turn complaints into opportunities for quality improvement.

White Paper: Effective Nonconformance Management Key to FDA and ISO Compliance
A product's safety and quality depend to a great extent on its conformance to specifications that have been tested and proven safe. For this reason, the proper handling of nonconforming products is incorporated in FDA regulations covering drugs, medical devices, and biologics, and ISO international standards, which apply to manufacturers of a wide range of consumer goods.

White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
It is often said that it is not quality, but the lack of it, that costs a lot of money. This is especially true in the strict FDA and ISO environments. This white paper suggests that an optimal quality management system, as a foundation for FDA and ISO compliance, will help you avoid the high cost of poor quality. Prepared by MasterControl Inc., this white paper offers six practical tips for optimizing your quality management system, ranging from automation of quality processes to utilizing training as a tool for continuous quality improvement.

Q&A: CDER Official Offers Tips on GMP Inspections
CDER Official Offers Tips on GMP Inspections, Validation of manufacturing processes, handling of deviations, and laboratory operations are the top three areas that FDA investigators scrutinize during GMP inspections, according to a senior regulatory operations officer with the Center for Drug Evaluation and Research (CDER).

Q&A: CAP Accreditation and Document Control
CAP Accreditation and Document Control, What's document control got to do with CAP accreditation? If your lab wants to obtain or maintain accreditation by the College of American Pathologists, a quick check of the inspection checklists will show you that document control is a requirement for those who fall under the "Laboratory General" category. And, for labs belonging to most other categories, document control is required for keeping electronic manuals.

White Paper: ISO 9000:2000 Quality Standards
ISO 9000 standards are a collection of international standards for application in all types of organizations. It is one of the most widely used quality standards in the world. This white paper lists specific requirements of ISO 9001:2000, the latest version of this standard, and how the MasterControl™ software solution meets them. It outlines ISO requirements vis-à-vis MasterControl functionality and shows how the software can help with such things as:

White Paper: ISO 14000 Quality Standards
ISO 14000 Quality Standards, The ISO 14000 series were designed to incorporate environmental aspects into manufacturing operations and product quality standards. ISO 14000 is the world's most recognized environmental management system (EMS) framework. It is applicable to organizations of all sizes, from small businesses to multinational companies. This white paper lists the requirements of ISO 14000 vis-à-vis the functionality of the MasterControl™ integrated quality management solution. It outlines specific requirements and how MasterControl addresses them, including:

Q&A: Compliance with FDA's Good Tissue Practice Regulations
GTP refers to FDA requirements that are meant to ensure the safety of human cell, tissue, and cellular and tissue-based products (HCT/Ps) by preventing the introduction, transmission, and spread of communicable disease.

Q&A: Risk Management for Pharmaceutical Companies Under FDA's Q9 Guidance
Q9 Quality Risk Management, "the document outlines principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality."

Medical Device Regulations - 21 CFR Part 820 Quality System Regulation QSR Requirements for Medical Device Manufacturers for Part 820 Compliance:

FDA 21 CFR Part 820, also known as the Quality System Regulation QSR outlines Current Good Manufacturing Practice CGMP regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe and effective. Medical device manufacturers undergo FDA inspections to ensure QSR compliance.

The MasterControl™ GxP process and document management suite is an integrated, configurable, and easy-to-use software solution especially designed to facilitate compliance with 21 CFR Part 820 and other FDA regulations. Here's how MasterControl can help medical device companies meet key QSR requirements and at the same time increase efficiency and keep compliance costs down:

About MasterControl

Corporate Headquarters: MasterControl Inc.
6322 South 3000 East, Suite 110
Salt Lake City, Utah 84121
P 801.942.4000
F 801.942.7088
www.mastercontrol.com
Toll Free: 800.825.9117
Contact by E-mail

European Headquarters:

MasterControl Global UK, Ltd.
7200 The Quorum
Oxford Business Park North
Garsington Road
Oxford OX4 2JZ
United Kingdom
P +44 (0) 1865 487188

F +44 (0) 1865 233233
www.mastercontrolglobal.co.uk

Toll Free: 800.825.9117
Contact by E-mail

Categories this company is listed under in the In Vitro Diagnostics Suppliers Directory:

• Electronic and Mechanical Components and Software: Software for Instrumentation Control (32 companies)
• Electronic and Mechanical Components and Software: Software for Product Design and Manufacturing (16 companies)