validation services - process and fda software validation
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Welcome to Automation and Validation Group
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.
Our Validation Services
Automated System ValidationEquipment ValidationProcess ValidationSoftware Validation ProcessFDA Validation ComplianceProduct Software ValidationProduct Validation ProcessNon Product Software ValidationFDA 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.
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.
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.
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.
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.
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.
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.
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.
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.
Address: 8569 Pines Blvd Suite 215
City: Pembroke Pines
Zip Code: 33024
Phone: (877) 232-2276
Email: [email protected]