Compliance Skills
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- » Validation Master Plan (VMP)
- » Computer Systems Validation
- » Risk Assesment
- » Systems Review and Remediation
Computer Systems Validation Services
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.
Validation Services
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 as well as validation master plan development and protocol development and execution. 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.
Validation Master Plan
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
- SOP's
- Training Approach
- System Maintenance, Backup and Security
- System Retirement
- Executive Summary
Computer Systems Validation
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
Risk Assesment
In order to ensure that the appropriate activities and effort are exerted in the validation process, a Risk Assessment should be performed. The assessment should take into account a systems impact on product quality and safety.
Systems Review and Remediations
Frequently a company is unsure of what is required for a computer system to be in compliance with FDA regulations. IAS can help by executing a systems review and remediation plan to bring current or legacy systems into compliance with FDA regulations. This could include configuration modifications, process changes or software modifications.