Demonstrated compliance and comprehensive quality management systems.

Oligo Factory has a documented Quality Management System (QMS) conforming to the quality system requirements of the following:

ISO 13485:2016*

Certificate Coming Mid 2024

FDA Title 21 CFR 820

US FDA Quality System Requirements


Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

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  • 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
  • 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

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.


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.

56 Boynton Rd, Holliston, MA 01746

Phone: (508) 275-3561
Email: Info@oligofactory.com