Quality control and assurance
ScinoRx offers skillful services in assessing and enhancing quality assurance and controls—from the way technical issues are handled to the organizational structure of quality units. Our team is proficient in the roles of QA & QC which includes:
- Evaluating written procedures and standard operating procedures
- Helping to interpret regulations in concert with industry standards
- Developing laboratory quality, analytical methods, methods validations, and product component specifications
- Creating a program to meet current FDA expectations for GCP Compliance
- Consulting self-evaluations
- Building sampling plans
- Performing trend analysis
- Providing corporate oversight programs and enhancement—including good governance practices; corporate quality/compliance functions and oversight practices, senior managers, and board members
- Implementing site oversight programs, including internal audits and performance metrics
- Reviewing and enhancing management control.
- Reviewing and enhancing organizational structures—including functions, reporting relationships, responsibilities, staffing and competence; communication systems and performance (vertical and horizontal); and independence, staffing, and competence of quality units.