Du All Controls, LLC


Your Partners in Compliance


Services

As seen below we follow the V model in most cases unless client request other models.

Validation V Model

Guidance

Predicate Rule Guidance
CFR 21 Part 11 Guidance
CSV (Computerized System Validation) Guidance
Change Control Guidance
Quality Assurance Guidance
Quality Control Guidance
System Design Development Guidance
SDLC Model (System Development Life Cycle) Guidance
GAMP 5 (Good Automated Manufacturing Practices) Guidance
IEEE (Institute of Electrical and Electronics Engineers) Software Development Guidance

Specialized Systems

EDMS (Electronic Document Management) Systems
ERP (Enterprise Resource Planning) Systems
LIM (Laboratory Information Management) Systems

Training

Audit Participation Training
Validation Training
cGMP (current Good Manufacturing Practices) Training
CFR (Code of Federal Regulations) Chapter 21 Part 11 Training
SOP (Standard Operating Procedures) Development Training

Validation

Validation Preparation Documentation

Concept Documentation
User Requirements Document
Risk Assessment Document
Functional Requirements Specification Document
System Design Specification Document
System Configuration Specification Document
Validation Plan

Protocols Preparation

Unit Test (UT)
Factory Acceptance Test (FAT)
Site Acceptance Test (SAT)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)

Protocol Execution

Unit Test (UT)
Factory Acceptance Test (FAT)
Site Acceptance Test (SAT)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)

Final Reports

Unit Test (UT)
Factory Acceptance Test (FAT)
Site Acceptance Test (SAT)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Validation Summary Report

Audits

Internal

Pre FDA Audit Preparation
CFR Chapter 21 Part 11
CFR Chapter 21 Parts 210 and 211
CFR Chapter 21 Parts 204 and 205
CFR Chapter 21 Part 820

External

Software Vendor
Pre Selection Software Vendor
Q7A for API or other Component Manufacturing Vendor
Contract Manufacturing Vendor