Our Service

S&D International Group Inc.

Our Service

Our professional services includes Computer System Validation(CSV) on a project basis, stuff augmentation, outsourced services, software process improvement and support for virtually all other aspects of software quality assurance and testing. We apply risk analyses throughout each engagement to stablish practical priorities consistent with business objectives and regulatory guidelines.

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We supply Quality Asurance (QA) solutions to help our clients ensure that their software-base system do what they are supposed to do. This includes veryfing functional, performance, and usability objectives; achieving regulatory compliance; and reducing the risk that seroius technical problems will surface later on during deployment and production usage.

"Using our Knowledge of FDA regulations and best practices, S&D consultans work with you to performe the required verifiation and testing activities throughout the entire Software Life Cycle and to check the porper operation of the software in its intended used enviroment. "

PRODUCTS

Validation Planning
Requirements definitions and traceability
Risk Assesment and Risk Mitigation
Software development Life Cycle(SDLC)
Vendor Interactions
Internal and External Audits
Installation Qualification(IQ)
Operational Qualification(OQ)
Performance Qualification(PQ)
Validation Summarization.
Inspections
Preventing Maintenance (PM)
Product Development

During on going operation of the system, S&D Consultants help you meet the challanges associated with maintaining validation status and working with you to:

Poperly document and validate system changes.
Accumulate sufficient evidence of management awareness and control.
Prepeared for audits and regulatory inspections.

The goal for the regulators is to ensure that quality is built into the system at every step, and not just tested for at the end, as such validation activities will commonly include training on production material and operating procedures, training of people involved and monitoring of the system whilst in production. In general, an entire process is validated; a particular object within that process is verified. The regulations also set out an expectation that the different parts of the production process are well defined and controlled, such that the results of that production will not substantially change over time. This also extends to include the development and implementation as well as the use and maintenance of computer systems. The software validation guideline states: “The software development process should be sufficiently well planned, controlled, and documented to detect and correct unexpected results from software changes.”