Why Choose Us
Expert Validation & Compliance Solutions
Unique Infinity Solutions is a leading validation consulting organization providing total regulatory compliance solutions. We ensure GxP compliance for Pharmaceuticals, Biotechnology, Chemicals, Healthcare, Clinical Research, Medical Device and Food Manufacturing industries. Our expertise in validation, regulatory compliance, and engineering solutions helps businesses meet stringent industry standards effectively.
- Regulatory Compliance Assurance
- Cost-Effective Validation Services
- Experienced Engineering Team
- Comprehensive Documentation Support
Our protocols are based on GAMP 5 guidelines
- Validation Plan (VP)
- System Requirement Specification (SRS)
- GAP Analysis (GAP)
- Risk Assessment (RA)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Validation Summary Report (VSR)
Reasons for Validation
FDA, or any other food and drugs regulatory agency around the globe not only ask for a product that meets its specification but also require a process, procedures, intermediate stages of inspections, and testing adopted during manufacturing are designed such that when they are adopted they produce consistently similar, reproducible, desired results which meet the quality standard of product being manufactured, such procedures are developed through the process of validation. This is to maintain and assure a higher degree of quality of food and drug products. Validation is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification.
Importance of Computer System Validation / PLC Validation
With the increasing stringency of GAMP 5 regulations, Computer System Validation (CSV) and Programmable Logic Controller (PLC) Validation have become essential for life science companies. Ensuring compliance is crucial to avoid regulatory issues and reputational damage.
Challenges in Implementing Fully Automatic Systems
Pharmaceutical companies face significant challenges in installing and maintaining fully automatic systems for different stages of production while ensuring compliance with regulatory requirements.
Our Expertise
Our team has extensive experience in validation services, ensuring that your systems are validated in a cost-effective manner. We guarantee that all predicate rules are satisfied, and complete activity documentation is provided.
Benefits of Our Validation Services
- Cost-effective validation solutions
- Ensured compliance with GAMP 5 regulations
- Proper documentation of complete activity
- Experienced team with expertise in validation services
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What We Do
Our Services
Unique Infinity Solutions provides comprehensive validation and regulatory compliance services across various industries, including Life Sciences, Healthcare, Pharmaceuticals, Clinical Research, and Medical Device Manufacturing. We specialize in ensuring compliance with GxP, GAMP 5, and international regulatory standards through structured validation processes.
Computer System Validation Services
We provide expert validation services ensuring IT systems function seamlessly and reliably.
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Our CSV Services Include:
We offer a wide range of Computer System Validation (CSV) services to ensure regulatory compliance and quality assurance for various industries. Our services include:
- PLC (Control System) validation
- HMI (Human-Machine Interface) validation
- SCADA (Supervisory Control and Data Acquisition) validation
- DCS (Distributed Control System) Validation
- Packaging equipment validation
- Laboratory equipment validation
- LIMS (Laboratory Information Management System) validation
- EMS (Environmental Monitoring System) validation
- BMS (Building Management System) validation
- FMS (Facility Monitoring System) validation
- DAS (Data Acquisition System) validation
- UDMS (Utility Data Monitoring System) validation
- CDMS (Central Data Monitoring System) validation
- Robotics based system validation
- DMS (Document Management System) validation
- QMS (Quality Management System) validation
- LMS (Learning Management System) validation
- E-logbooks validation
- e-BMR (Electronic Batch Manufacturing Record) software validation
- Warehouse Management System validation