Why Choose Us for Software Validation?
1. Regulatory Expertise:
We understand the complex regulatory landscape governing the life sciences industry. Our validation processes align with key guidelines and standards, including:
Compliance with electronic records and electronic signatures.
Compliance with electronic records and electronic signatures.
Ensuring quality, safety, and efficacy across the product lifecycle.
Meeting FDA requirements for software validation.
Adhering to European regulations.
Global harmonization of technical requirements for pharmaceuticals.
ISO (International Organization for Standardization).
2. Risk-Based Approach:-
Our validation plans prioritize high-risk areas of your software system. By focusing testing efforts where they matter most, we optimize efficiency while ensuring full compliance.
3. Validation Master Plan (VMP):
We begin each project with a solid VMP. This detailed document outlines the validation strategy, deliverables, risk assessment, testing approaches, dependencies, scheduling, and resource allocation.
4. Training and Skills Development
Our validation plans prioritize high-risk areas of your software system. By focusing testing efforts where they matter most, we optimize efficiency while ensuring full compliance.
Our Comprehensive Validation Services
Custom software development requires thorough validation. We assess the entire development lifecycle, from design to deployment, ensuring compliance with industry standards.
Our validation process includes functional testing, security assessments, and performance validation.
When integrating software systems, we validate data exchange, interoperability, and seamless functionality.
We verify that integrated systems comply with relevant regulations and guidelines.
As cloud adoption grows, validating cloud-based solutions becomes crucial. We validate cloud infrastructure, data security, and access controls.
Compliance with 21 CFR Part 11 and other standards is central to our approach.
Existing legacy systems require validation to ensure ongoing compliance.
We assess legacy systems, identify gaps, and implement necessary updates.
Documentation Details
We create detailed validation protocols for each software system. These documents outline the specific tests, acceptance criteria, and procedures used during validation.
Protocols cover installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Our traceability matrix maps requirements to test cases. It ensures that every requirement is adequately tested and validated.
We maintain comprehensive test scripts and generate detailed test reports. These documents provide evidence of successful validation.
Our change control procedures document any modifications to the software system during its lifecycle. This ensures that changes do not compromise compliance.
Benefits of Our Services
Our validation processes guarantee compliance with industry regulations, reducing risks and potential penalties.
Validated software systems lead to improved product quality and patient safety
Efficiently validated systems streamline operations, saving time and resources.
Demonstrating compliance and quality gives your organization a competitive advantage.
Software Validation
Ensuring Compliance, Quality, and Efficiency
At VitelyTech, we specialize in providing comprehensive software validation services tailored specifically for the life sciences sector. Our team of experts combines industry knowledge, regulatory expertise, and cutting-edge technology to ensure that your software systems meet the highest standards of compliance, quality, and efficiency.