Highly experienced in the development and implementation of Quality Systems for pharmaceutical, biotech and medical device organizations that are compliant with all applicable Code of Federal Regulations (21 CFR 210, 211 and 21 CFR 820).
ATV can develop, implement and audit Quality Systems to ensure your organization is compliant with applicable standards developed by the International Standard Organization (ISO).
ISO compliance provides a method for a company to continuously self-improve in order to achieve and maintain an error-free environment. ISO is a reputable organization, therefore an ISO certification grants credibility to companies seeking to operate globally. Additionally, some partnership contracts require ISO compliance; there certification opens new business relationships.
ISO standards have been adopted globally and certification has become a mark of distinction in the industry.
Quality System Development
ATV can author and implement compliant Standard Operating Procedures (SOPs) governing all aspects of a cGMP operation. Quality Systems include but not limited to the following:
- Quality Manual
- Quality Policy
- Change Control Systems
- Deviation Procedures
- CAPA Systems
- Document Control
- Good Documentation Practices
- Supplier Management
- Training program
ATV can assess your company's compliance level by auditing the Quality System for adherence to applicable ISO standards and / or the Code of Federal Regulations (CFR). ATV utilizes highly experienced Certified Quality Auditors to perform all audits. A comprehensive audit report will be provided at the conclusion of each audit. ATV can also assist in closing the compliance gaps identified.
Audit Support / Management
Whether it is developing your facilities' Inspection Readiness plan, hosting the audit, or developing recommendations and strategies to address previous audit observations, ATV can support your facility through all types and stages of a regulatory or customer audit.