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VATechWrite provides the highest
quality documentation for your business needs
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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. |
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| 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?" |
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