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Our founders have experience providing FDA compliance validation for companies governed by FDA regulations.
Call 267-661-8362 to learn more about our FDA Compliance experience.
"I have worked with IAS for over 8 years; over that time they have developed innovative solutions that have become true advantages over our competitors. IAS has been great to work with due to their flexibility, quick response and quality performance. The solutions that they have created are easy for our users to learn and are custom fit for our operations. They have been a great partner." - Wes Farley, Director
“IAS has been providing Pecora with IT support for over 10 years. From desk top and network administration to software development, IAS provides outstanding and timely support. “ Deb Raskob, Controller, Pecora Corporation
"It is with great pleasure that I recommend Information Age Systems, LLC. They have been Dudlik Industries Inc. IT consultants since 2007. IAS has always displayed a high degree of knowledge, responsiveness, and professionalism with all aspects of the IT world. IAS was able to switch our entire network, and software with very minimal effect on our daily operations. They assisted us with the purchasing of hardware, and software while always keeping our budget in mind. All aspects of our network and system implementation were discussed, and documented prior to any work being started. IAS is willing to work after hours as to not disturb our daily operations and also with our employees that are located in Florida and Oregon. Information Age Systems would be an asset to any organization, and I am happy to give them my wholehearted endorsement." - Jay Obarowski of Dudlik Industries, Inc.
IAS provides a complete range of validation services for companies regulated by the FDA. These services include risk assessment, gap analysis, validation planning, and remediation. Whether it is the implementation of a new system or an audit and remediation of an existing application Information Age Systems can help. We utilize the principals outlined for Good Automated Manufacturing Practices, (GAMP) to help our customers adhere to computer systems validation requirements.
IAS also has experience with Chapter 21 Part 11 Audit Trails and Electronic Records Signature requirements.
A solid Validation Master Plan is one of the key documents for ensuring that a computer system or architecture meets the requirements for compliance. The VMP provides an auditor with your company's validation strategy and guiding principles. The document identitifies a structured approach for ensuring compliance. Typical components of a VMP are:
- Systems Scope
- Roles and Responsibilities
- Organization Structure
- Validation Strategy
- Acceptance Criteria
- Change Control
- Training Approach
- System Maintenance, Backup and Security
- System Retirement
- Executive Summary
As predicated in the Validation Master Plan, the development of appropriate testing protocols is required to provide documented evidence that a particular system is operating as designed and is appropriate for the designated task. The Validation should include
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- Design Specification (DS)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Performance Qualification (PQ)
- Executive Summary