Organizations today want to make the compliance shift not only to comply with the FDA, but to save ample amount of administration time that would be used for quality management and document control. Validation will always remain as one of the essential indicators of quality and efficiency which directly affects the production of high quality medicines and devices before it enters the market. Therefore, all the checklists must be met to ensure the systems are compliant with the industry regulations and standards.
Compliance with Industry Regulations and Standards
Deploying new software brings its own set of challenges especially in highly-regulated environments such as healthcare & medical devices. Companies under these industries have to be compliant with FDA and other international regulatory requirements for security, data integrity, electronic signatures and functionality through software validation.
ReliSource’s Validation team helps clients ensure that they are in compliance with the industry regulated standards so that the business risk can be minimized. As experts in computer system validation services, we help our clients in maintaining accuracy, reliability, performance consistency and detect invalid or altered records as described in the FDA 21 CFR Part 11. This compliance is essential for those companies that wish to use electronic quality records and signatures as opposed to paper-based to comply with FDA regulations faster and more efficiently.
- Computer System Validation
- Device Qualification
- Customized & COTS Application Qualification
- Network & Infrastructure Validation
- Data Center Validation
- Validation Planning
- Requirements Gathering & Documentation
- Installation, Configuration & Development
- Verification (IQ/OQ/PQ) Testing
- Validation Reporting
- Traceability Matrix
- Risk Assessment
- Process Development
- Validation Plan (VP)
- Business Process Description (BPD)
- Functional Requirement Specification
- System Design Specification
- Configuration Specification
- Installation Specification
- System Test Plan
- User Acceptance Test (UAT) Plan
- Design/Installation/Operation/Performance Qualification (DQ/IQ/OQ/PQ) Scripts
- Incident Report Forms (IRF)
- IQ/OQ Results (Test Environment)
- System Test Scripts (AST/MST)
- UAT Scripts
- System Test Results + Evidences
- UAT Results + Evidences
- Test Summary Report (TSR)
- Release Notes
- Release-to-Production Memo
- IQ/OQ Results (Product) & IRFs
- Validation Summary Report (VSR)
- Qualification Summary Report (QSR)
Values we bring in to increase your ROI
- Extensive Experience and Domain Knowledge obtained from working with Fortune 500 Companies in Healthcare & Medical Device industries
- Significantly reduce validation costs and expedite deployments
- Minimize the time and cost of validation associated with future enhancements and configuration changes
- Expertise on Industry Standards & Regulatory Compliance such as HIPAA, FDA regulations (21 CFR Part 11, Part 820, etc.)
- One-Stop Solution from Device/Application Development, Integration to Qualification and/or, Validation services
- Delivers Extremely High ROI by using latest tools & technologies and via proven working model
- Promote continual process improvement. As software is constantly evolving, there is a need to keep up with the increasing complexity that users experience. Therefore, validation is an ongoing necessity