About Us
CoGenyx has a proficient team of Technical Writers adept at creating qualification protocols and final reports that surpass standard requirements. If you’re still in the process of establishing a document template, rely on our experts. We can suggest essential components for your reports and protocols, and then tailor these elements to fit your specific site and applications. In addition, we offer our proficiency in refining existing documentation to improve compliance standards. With our extensive experience in global regulatory compliance, we are well-positioned to facilitate your journey towards global harmonization.
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Our Skills
Technical writing is a core skill for our engineers, especially in Computer Systems Validation and Assurance (CSV/CSA) and Commissioning, Qualification, and Validation (CQV). Our consultants focus solely on Technical Writing for controlled documents, such as work instructions, job aids, SOPs, and more.
We have extensive experience in the pharmaceutical industry. These are just a sample of the many documents we have produced for our clients.
- Change Control Records
- Standard Operating Procedures
- Engineering Documents
- Deviation Investigations
We take a full-service approach to ensuring your facilities, equipment and processes meet regulations set by regulatory bodies.