validation services - process and fda software validation

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Welcome to Automation and Validation Group

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Page 1: Validation Services - Process and FDA Software Validation

Welcome to Automation and Validation Group

Page 2: Validation Services - Process and FDA Software Validation

About us

ADB Automation and Validation Group provides custom automated equipment that we tailor for each client’s specific needs. We design, program, and build automated equipment for use in a variety of sectors, including research and development, manufacturing, and quality control.

Page 3: Validation Services - Process and FDA Software Validation

Photo Gallery

Page 4: Validation Services - Process and FDA Software Validation

Our Validation Services

Automated System ValidationEquipment ValidationProcess ValidationSoftware Validation ProcessFDA Validation ComplianceProduct Software ValidationProduct Validation ProcessNon Product Software ValidationFDA Software Validation

Page 5: Validation Services - Process and FDA Software Validation

Automated System Validation

The basic idea of validation is to ensure that the client’s current and long-term needs are met properly. Obviously, if the system is not capable of serving the intended purpose, there is no fun of moving forward to other processes such as quality assurance.

Page 6: Validation Services - Process and FDA Software Validation

Equipment Validation

Equipment Validation service is specifically for lab and medical equipments. Chemical and Medical industry is one of those industries that require precise and accurate results. A wrong reading by the equipment may lead to fatal consequences and even loss of life.

Page 7: Validation Services - Process and FDA Software Validation

Process Validation

Process Validation involves the review of production batch records to establish thorough documented evidence assuring that the process will consistently produce a product that meets the quality standards and specifications.

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Software Validation Process

Software Validation Process is the process of determining that the specifications of the software coincide with the user’s needs and perform functions for which it is intended.

Page 9: Validation Services - Process and FDA Software Validation

FDA Validation Compliance

If the FDA Validation Compliance finds a manufacturer violating the compliance, the consequences can be detrimental. This may result in temporary shutdowns, warning letters, mandatory product recalls and criminal penalties depending on the severity of the violation.

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Product Software Validation

Product Software validation encompasses various services which include design reviews, code inspections, test plan development, formal validation, and off-the-shelf software.

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Product Validation Process

Product validation process is a sequence of steps that are taken to determine whether the product will be able to successfully achieve the intended purpose or not.

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Non Product Software Validation

The Non Product Software Validation is actually a process of producing evidence that confirms that all the user requirements have been fulfilled and implemented completely and correctly. These requirements shall be traceable to software requirements and all verification/validation activities shall be performed.

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FDA Software Validation

The motive of the FDA Software Validation is to speed up the availability of new software technologies into the market without compromising scientific integrity in the decision-making process or the ability of FDA to protect and promote public health.