Oligonucleotide Quality Assurance & Control
Demonstrated compliance and comprehensive quality management systems.
Quality Management System
Oligo Factory has a documented Quality Management System (QMS) conforming to the quality system requirements of the following:
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Quality Management System (QMS) includes:
- Device Master Records
- Control of Documents
- Control of Records
- Certificate of Analysis
- Supply Chain Management and Material Traceability for Critical Raw Materials
- Commercial Contracts (Non-disclosure, Material Transfer, Supply Agreements, Supplier Quality Agreements including Change Notification managed by Quality Assurance)
- Corrective and Preventative Actions (CAPA)
- Installation Qualification, Operational Qualification and Process Qualification (IQ/OQ/PQ) programs for instrumentation
Quality for Oligonucleotide Synthesis and Purification:
- Closed-system single oligonucleotide synthesis platform
- Sequence Identity Verification by Mass Spectrometry (Molecular Weight confirmation)
- Validated Laboratory Information Management System (LIMS) – Waters NuGenesis LMS
- Purity Verification by Analytical HPLC – Ion Pairing Reverse Phase (IPRP) or Anion Exchange high-performance liquid chromatography
- Quantification by UV Spectroscopy
- Lyophilization by calibrated Labconco lyophilizers
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Quality Policy
Oligo Factory provides high-quality custom oligonucleotides that allow Life Science and Therapeutic customers a path from research to clinical and commercial stages.
We are committed to be on the leading edge of oligonucleotide preparation and ensuring complete customer satisfaction through process innovation, adaptability, and responsiveness.
We achieve this by:
Complying with applicable customer, quality, safety, and environmental requirements
Monitoring our customers’ satisfaction levels and taking appropriate actions for improvement
Continual improvement of our processes, people, and systems by establishing and reviewing Quality Objectives and maintain the effectiveness of the quality management system.
About
Quality Management at Oligo Factory
Founded in 2006 by oligo synthesis technology experts, Oligo Factory is a leader in manufacturing custom DNA and RNA oligonucleotides at medium- to large-scale quantities for the research, diagnostic, therapeutic and life science communities. At Oligo Factory, our commitment to exceptional quality control, adherence to stringent global regulatory standards, and customer service is core to our business purpose to drive the next generation of therapies and life science tools, resulting in a healthier, more sustainable future.
Oligo Factory has implemented a comprehensive Quality Management System (QMS) to align its operations with ICH Q7 GMP guidelines. This includes enhanced documentation and traceability practices, rigorous training programs for employees, regular audits, and continuous improvement initiatives.
Address:
56 Boynton Rd, Holliston, MA 01746
Contact:
Phone: (508) 275-3561
Email: Info@oligofactory.com
