FTL | ERP Software Validation

Validation Services.
FTL can assist you with your complete validation needs. From validation analysis and plans to specifications and standard operating procedures, FTL has experienced professionals to assist you.

Software Validation / Verification

Validation Plans

Concept/Proposal Documents

Requirements Specifications, User and Functional

Risk Assessment Reports

Design Specifications

Traceability Matrixes

PQ/IQ/OQ Documentation

Test Protocols and Test Reports

Standard Operating Procedures

Generation and revision of operation procedures for quality assurance purposes.

Training Programs “How To Write Standard Operating Procedures”: By using a common theme, attendees will be able to understand, remember and share with others the concepts behind writing great SOPs. By investing in well-written Standard Operating Procedures, companies will save money in training costs and achieve quantifiable goals.

FDA 21 CFR Part 11: Evaluation and re mediation planes for guideline compliance.

Audit Re mediation: Work with QA and Regulatory Affairs to remedy audit findings.

Gap Analysis: Perform system and software gap analysis for fiscal decisions.

Workflow & Process Diagramming: Visual diagrams of workflow and process flow for development and documentation purposes.

Technical Manuals: User Guides, Service Provider Manuals and Release Notes.

SOX IT404 Compliance Consulting
FTL has the SOX knowledge as well as the QAD knowlwdge to help you through the Sarbanses-Oxley maze. We can help you with:

Planning and Discovery
Procedure Review
Developing Control Matrixesl
Defining Control Activities
Design Test Plans
Control Testing
Remediation and Risk Management
Final Compliance Report

Experience That Counts
FTL consultants have real life management experience running FDA regulated manufacturing and IT departments. We've implemented and validated ERP systems for the high tech medical device and chemicals community for over 10 years.

For more information, contact Gordon:
Phone +1 408 210 7723 or
E-mail: gordon@ftlcorp.com