Cancard Interview Questions and Answers

CSV stands for Computer System Validation. Automation testing is the use of software to execute tests.

• CSV is a process of ensuring that a computer-based system meets its intended requirements and is compliant with regulatory standards.

• Automation testing involves using software tools to run tests automatically, reducing the need for manual testing.

• CSV and automation testing are often used together to ensure that computer systems are validated and tested thoroughly.

• Examples of ...read more

21 CFR part 11 is a regulation by the FDA that defines the criteria for electronic records and electronic signatures in the pharmaceutical industry.

• 21 CFR part 11 is a regulation under the Code of Federal Regulations (CFR) Title 21, which is enforced by the U.S. Food and Drug Administration (FDA).

• It sets the standards for electronic records and electronic signatures used in the pharmaceutical industry.

• The regulation ensures the authenticity, integrity, and reliability of elec...read more

GAMP guidelines are a set of principles for validation of computerized systems in pharmaceutical and biotech industries.

• GAMP stands for Good Automated Manufacturing Practice

• It provides a framework for validation of computerized systems in regulated industries

• GAMP guidelines are divided into five categories: Category 1-5

• Category 1 is for infrastructure and Category 5 is for software applications

• Gxp Project related bugs are those that affect the compliance of the system with GA...read more

There are several categories of software, including system software, application software, programming software, and malware.

• System software

• Application software

• Programming software

• Malware

SDLC refers to the software development life cycle. There are various types of hardware such as input, output, storage, and processing devices.

• SDLC is a process followed by software development teams to design, develop, and test software.

• Hardware can be classified into four types: input devices (e.g. keyboard, mouse), output devices (e.g. monitor, printer), storage devices (e.g. hard disk, USB drive), and processing devices (e.g. CPU, GPU).

• Validation engineers ensure that the...read more