GxP Documentation

At Sequoia, our technical writers are subject matter experts, with extensive biotechnology, medical device and pharmaceutical experience. We see the big picture, and we get the details right.

Our documentation team understands the life sciences value chain, and has extensive experience with biotech processes, regulations and technologies. We support you through the entire process of document and template creation, review, revision and approval, taking you from Phase I to production. We use standardized and consistent documentation practices that reduce review times, deviations and inconsistencies in existing records.

Sequoia writers have manufacturing, automation, engineering, validation and quality systems experience. We communicate proactively and work collaboratively to achieve cross-functional buy-in, which enhances document quality and streamlines the review, revision and approval process.

We write, edit and review:

  • GxP manufacturing documents
  • Batch records
  • Administrator and operator SOPs
  • Work Instructions
  • Validation & commissioning protocols
  • Design specifications & qualifications
  • User requirements specifications (URS)
  • Functional Specifications (FS)
  • Test cases
  • Summary reports
  • Workflow diagrams and charts
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