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.

If you prefer, please feel free to fill out the form below and someone will contact you promptly.