VATechWrite Services

VATechWrite provides the highest quality documentation for your business needs

Software and Process Validation VATechWrite has extensive experience providing verification & validation documents including:

    Master Validation Plan (MVP)
    Quality Assurance Plan (QAP)
    Configuration Management Plan (CMP)
    Test Plan (TP)
    Requirements Specification (FRS, SRS, IRS)
    Design Specifications (GDS, DDS)
    Installation/Operational Qualification (IOQ)
    Factory Acceptance Test (FAT)
      Site Acceptance Test (SAT)
      Functional Test Specification (FTS)
      Summary Test Report (STR)
For more information, review our Software Validation service page.

Manuals From small user manuals to unabridged Operation and Maintenance (O&M) manual sets, VATechWrite has experience in providing concise, accurate manuals written in simple, understandable terms. We provide customers with:

    Operation and Maintenance Manual
    Software User Manual
    Computer Operation Manual

For more information, review our Manuals service page

Policies and Procedures Good business practices call for documents that establish how a company conducts their business activities. VATechWrite has experience creating policies, procedures, and work instructions, easily understood by their target audiences.

For more information, review our Policies & Procedures service page.

Validation

Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

21 CFR Part 820 Medical Devices; Current Good Manufacturing Practice (CGMP); Final Rule, October 7 1996

Minimal Manual

The minimal manual focuses on the real tasks and activities - Instead of telling a reader how to use all the functions of product, the minimal manual tells them how to do a task.

Policy

Policies answer the question, "Why do we do this?" Policies consist of a statement of purpose and one or more broad guidelines as to how the guidelines will be achieved.

Procedure

Procedures, or sometimes referred to as process descriptions, and work instructions answer the questions: "What is done, who does it, where is it done, and when is it done?"