Quality Advice is a consulting company dedicated to meeting the needs of clients within the regulated life sciences industry by providing guidance and support for the implementation or monitoring of quality and computer systems; and the conduct of data integrity audits, computer system validations, and training.
- Provide quality assurance guidance and monitoring
- Conduct audits
- Provide training
- Prepare or review standard operating procedures
- Prepare or review computer system validation packages
Ensuring continued quality and compliance, efficiently.
- US FDA and OECD GLP regulations
- US FDA and EudraLex Volume 4 GMP regulations.
- US FDA 21 CFR Part 11 and EudraLex Volume 4 Annex 11
- FDA Quality System Regulation