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Consent Decree Documentation Remediation

Are you involved in a Consent Decree Remediation project and need experienced writers?

Our writers and consultants are experienced working on large-scale FDA Consent Decree remediation projects. An important focus of remediation is the creation and updating of documentation. Experienced writers are key to the success of any remediation and we can provide you an experienced team of writers.

Some of the Consent Decree and Quality Systems documentation we have produced include:

    • CD Binders
    • Document Management SOPs
    • Engineering Document/Drawing Management SOPs
    • Engineering SOPs
    • Engineering Lifecycle SOPs
    • Environment Management SOPs
    • Facilities SOPs
    • Final Reports
    • Gap Analysis
    • General Policy SOPs
    • Information Technology (IT) SOPs
    • Maintenance SOPs
    • Manufacturing SOPs
    • Metrology SOPs
    • Organizational Assessments
    • Security SOPs
    • Summary Reports
    • Trace Matrices
    • Training Material
    • Training SOPs
    • Quality Assurance (QA / QE) SOPs
    • Quality Systems SOPs
    • Validation SOPs
    • Validated Computer System SOPs
    • Validated Computer System Lifecycle SOPs

We work effectively with members of your project team to establish the scope of your documentation efforts. Let Precisely Write build a plan for your project, drive the document review and approval process, and lead the writing effort from outline to finished documents.

Contact us at for a free consultation. Or call us at 1-800-985-7701.

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