I am a seasoned consultant in Regulatory Compliance and Computer System Validation (CSV) holding an MSc degree. My expertise lies in the realm of technical documentation and compliance validation, encompassing various regulatory authority guidelines.
I am committed to providing comprehensive assistance to companies navigating the complexities of compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures, as well as Annex 11, Computerized Systems. My focus extends to offering holistic solutions for quality management systems, encompassing various investigative processes within the pharmaceutical domain.
The process of Computer System Validation (CSV) is a pivotal aspect of our services. Widely employed in the pharmaceutical, healthcare, and other regulated industries, CSV is designed to ensure that computerized systems adhere to predefined requirements and regulatory guidelines. The primary objectives of CSV are to guarantee the reliability, integrity, and security of computer systems utilized in critical processes, such as manufacturing, laboratory testing, data analysis, and documentation.