Cerebtec Technologies Interview Questions and Answers

Discrepancy refers to a difference or inconsistency between two or more pieces of information. It is used to identify and resolve errors or inconsistencies in data.

• Discrepancy is commonly used in quality control and validation processes.

• It can be identified through comparing data from different sources or through manual review.

• Examples of discrepancies include mismatched data, missing information, or conflicting data.

• Discrepancies should be resolved before finalizing data or ...read more

Yes, I perform validation activities as part of my job responsibilities.

• I am responsible for ensuring that all processes and systems meet regulatory requirements.

• I conduct validation tests and document the results.

• I work closely with cross-functional teams to identify and address any issues that arise during the validation process.

• Examples of validation activities I have performed include software validation, equipment validation, and process validation.

21 CFR Part 11 is a regulation by the FDA that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

• 21 CFR Part 11 applies to electronic records and electronic signatures used in FDA-regulated industries, such as pharmaceuticals, medical devices, and biologics.

• It requires that electronic records be secure, accurate, and accessible, and that electronic signatures be unique, verifiabl...read more

Validation deliverables include validation plan, protocols, reports, and summary.

• Validation Plan: outlines the scope, approach, and resources for validation

• Validation Protocols: documents the testing procedures and acceptance criteria

• Validation Reports: summarizes the results of testing and any deviations from acceptance criteria

• Validation Summary: provides an overall assessment of the validation process and results

GAMP 5 is a category for software validation in the pharmaceutical and biotech industries.

• GAMP 5 stands for Good Automated Manufacturing Practice 5.

• It provides guidelines for the validation of automated systems in the pharmaceutical and biotech industries.

• It categorizes software based on its impact on product quality and patient safety.

• The categories range from Category 1 (low impact) to Category 5 (high impact).

• Examples of Category 5 software include systems that control cri...read more