Field Issue System

Field Issue System allow companies to manage service requests required for resources located at customer sites.

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Product Accountability Systems

Product Accountability systems ensures that the traceability of parts and product are traceable from the raw material stage to the receiving user.

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Returns Goods Systems

Return Goods Systems allows product return requests and receipts to be managed to support product traceability.

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Supplier Management Systems

Supplier Management Systems allows workflow processing and tracking of compliance for vendors and suppliers required to follow qualification and maint ....

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Training Management Systems

Training Management Systems allow tracking of specifications, users, training matrix, and training classes.

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Version Control Systems

Version Control Systems allow the management of software files with the ability to revert, branch, version, and track related changes.

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Document Management Systems

Document Management Systems allow users the possibility of full/hybrid electronic document, data and signature management via enterprise or paper-base ....

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Complaints Systems

Complaint Management Systems allow the storage of field generated events related to the product or supporting process.

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Non-Conformance Systems

Non-Conformance Systems allow users to track deviations from expected manufacturing and Quality Control Processes.

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Corrective and Preventative Action Systems

Corrective Action and Preventative Action Processes allow Quality Assurance to employ an assessment, investigation, and resolution of customer and int ....

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Cleaning Validation

Cleaning Validation is the process of obtaining documented evidence that assures than an equipment-specific cleaning process will consistently yield r ....

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Design Controls

“Design Controls” refers to several processes and procedures that the manufacturers need to follow when designing and developing medical devices. The ....

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Equipment Validation

The medical and laboratory equipments need to deliver results with a high degree of precision. Therefore, they must be validated and verified to confi ....

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Failure Mode Effects and Analysis

The detection of failures and defects in the later stages of development or during the final testing phase is expensive and time consuming. Failure Mo ....

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Process Failure Mode Effects and Analysis

Process Failure Mode Effects and Analysis (pFMEA) is a strategic approach that helps identify and eliminate potential failures of the manufacturing pr ....

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Process Validation

Once the manufacturing documentation clearly defines the final production steps, the next stage is to validate the development process. ADB Consulting ....

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Software Validation

The quality and reliability of software products is now becoming the key consideration for the majority of businesses, particularly the highly regulat ....

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Test Method Validation

Test Method Validation is another regulatory mandate by FDA that confirms whether the analytical procedure employed for a specific test is suitable fo ....

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Validation

Validation of IT solutions has become a mission critical subject during the last few years. The process which is just another phase of software develo ....

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Installation Qualification

No one can understand your automated and quality management systems better than the people who themselves design, develop and support them. The traine ....

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Clinical Failure Mode Effects and Analysis (cFMEA)

Assuring patient safety and improving the quality of care is the foremost priority of every healthcare firm. Clinical Failure Mode Effects and Analysi ....

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Design Failure Mode and Effects Analysis

Design FMEA is a systematic procedure to identify that the materials being used in the product design are according to the customer specifications, an ....

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Functional Testing

Functional Testing is a quality assurance process that verifies that the software application performs and functions in accordance with the pre-determ ....

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Performance Qualification

Performance Qualification verifies whether the device or equipment function correctly and consistently for the intended application or not. This phase ....

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User Assessment testing

End-user requirements and expectations with the product are subjected to review and change. User assessment testing verifies that the product or syste ....

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Operational Qualification

Operational Qualification is a process of producing evidence that the system components are working in accordance with the pre-determined specificatio ....

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Continual Improvement Procedures

Continual Improvement is an important part of the industry’s quality management system. It involves various procedures designed for the continuous imp ....

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Design Verification Procedures

Design Verification Procedures refer to a set of activities performed to ensure that the product design is capable of performing tasks as intended. Ma ....

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Equipment Preventative Maintenance Procedures

Taking care of assets is critical for the industries to ensure that equipment is capable of meeting production schedules on time, efficiently supports ....

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Facility Management Procedure

Healthcare facilities including medical industries are constantly needed to maintain a healthy and clean environment. For medical firms, it is import ....

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Facility Preventive Maintenance Procedures

Facility Preventive Maintenance Procedures

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Health Canada Mandatory Reporting Procedures

Health Canada encourages manufacturers, importers and device user facilities to report any medical device related issues that have occurred during dev ....

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Identification and Traceability Procedures

Product protection and visibility is very crucial for safe and secure supply chains. This visibility is obtained when the movement of products along ....

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Labeling and packaging procedures

Product protection and visibility is very crucial for safe and secure supply chains. This visibility is obtained when the movement of products along ....

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Laboratory Notebook Procedures

Lab notebook is a legal document that needs to be obtained during patent approval or FDA audit trials. It is a complete and accurate record of exper ....

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Process Performance Qualification

Process Performance Qualification (PPQ) is a stage of process validation in which the process design is evaluated to determine if it is capable of re ....

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Process Validation Procedures

Process Validation Procedures establish the controls required to validate the industrial processes. The framework provides a high degree of assurance ....

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Product Development Plan

The manufacturing industries, especially medical device and pharmaceutical, today face numerous challenges. Some of these include lack of ability to ....

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Risk Analysis Procedures

Risk analysis involves determining the consequences and identifying the likelihood of risks that may affect the success of a project or fulfillment of ....

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Risk Management Procedures

Product liability and regulations have become critical issues for the medical device industry. For this reason, device manufacturers struggle to have ....

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Safety Manuals

A safety manual is a crucial part of every medical device industry. It basically outlines company’s rules and policies that the employees are obliged ....

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Shipping procedures

According to FDA regulations, the medical devices that emit radiations and that are imported into the United States must comply with applicable U.S. r ....

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Software Validation Procedures

FDA’s ‘General Principles of Software Validation’ outlines several guidelines that industries should consider for software validation. Especially for ....

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Statistical Techniques and Applications Procedures

In medical and healthcare industry, analyzing and recording service utilization data and risks is a quite difficult process. This has given rise to t ....

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Storage handling and disposal of Biohazards Procedures

Storage handling and disposal of Biohazards Procedures

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Tooling Specification procedures

Tooling management is an urgent need for the efficient medical device manufacturing environment. Accurate functioning of instruments, gauges, apparatu ....

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Independent Code Review

Pushing code for your industrial applications to enter the production process without first properly reviewing it for reliability and security adds si ....

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Unit Testing

Unit testing is a software testing method in which smallest, individual units of source code are tested to check whether they can achieve their own si ....

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Design Validation Procedures

Design validation procedures refer to a set of activities performed to ensure that your design is capable of meeting user defined specifications and r ....

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What our customers have to say about us:

Andre and his team were professional, focused and sensitive to the timing issues associated with my project. Most importantly, after the project completed Andre and his team did not disappear. As I needed answers and follow up information, his team followed up in a timely and accurate manner. I look forward to using the services again and would recommend them highly.
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