Oligonucleotide Quality Assurance: Quality Management System Components

Key components of our QMS (quality management system) include: certificates of analysis; document control; change notification; vendor management; business agreements; and, corrective and preventive actions. Each component drives quality assurance, and for verification, we routinely host rigorous registrar, internal, and customer audits

Certificates of Analysis

Our certificates of analysis (CoA) come with relevant information, such molecular weight and melting temperature. We can also include mass spectral and analytical HPLC traces. In addition, we can work with you to develop the content and format for your CoA to meet your incoming release criteria and streamline your acceptance process.

Document Control

Good documentation practices are critical to our QMS including detailed batch records for ISO 13485 manufacturing. Staff are continuously trained to stay current on document and underlying process changes.

Change Notification

Customers who are included in our Change Control Notification program are linked with our Quality Assurance Change Management process for transparency and risk mitigation.

Vendor Management

We produce the highest quality chemicals and reagents providing unmatched strength in supply chain management. For externally sourced materials, our supplier qualification program ensures materials meet our exacting standards. Our enterprise resource planning systems and meticulous record keeping provide complete material traceability throughout manufacturing.

Business Agreements

Establishment of confidential disclosure and supply agreements are key to a successful partnership. Our agreements clearly communicate expectations and responsibilities to ensure confidentiality, product requirements and continuity of supply.

Corrective and Preventive Actions

We continually strive to improve the effectiveness of our QMS by eliminating and preventing nonconformances in addition to validating actions taken along with their effectiveness.

Conclusion

Several key components of our QMS are a big part of our overall quality assurance. If additional help is needed, please consult our technical services group at oligotechserv@sial.com.