Commissioning, Qualification & Validation
We help clients ensure their facilities and assets are properly commissioned, qualified, and validated in an efficient, compliant manner. We ensure that industry regulations are met, while still meeting aggressive timelines and budget constraints.
We have an experienced, diverse workforce with technical depth that enables us to effectively deliver projects right the first time. We implement standardized CQV approaches to ensure consistency and efficiency throughout all phases of your project.
We are well versed with science and risk-based approaches and have implemented verification methodologies on hundreds of projects, which has allowed us to effectively manage project risks and streamline project delivery. In addition, we have CSV experts that deliver automated assets in accordance with industry regulations and best practices to ensure data integrity. We leverage our technology partners and utilize technical solutions such as electronic validation to deliver projects efficiently and get your products to market faster.
Risk-based CQV activities are critical to compliance in highly regulated industries.
With an increased focus on compliance, speed to market, and equipment reliability, CQV or verification activities have never been more important. As a leader of manufacturing and packaging solutions within the Life Sciences industry, Verista specializes in and provides comprehensive risk-based verification strategies comprised of commissioning, qualification, and validation activities. We have experience providing CQV support for small and large-scale equipment, integrated manufacturing and packaging lines, cleaning systems, facilities, utilities, and HVAC systems. In addition, we ensure that your computer systems perform accurately, reliably, and consistently, with the ability to discern invalid or altered records and maintain manufacturing compliance. We streamline verification activities with first-time success and optimum schedule adherence.
Commissioning & Qualification
We provide commissioning and qualification (aka verification) services and support to our clients for their equipment, facilities and processes using the latest technologies and proven delivery strategies.
We develop and implement verification solutions that are compliant with industry regulations and drive increased efficiency, cost reduction and schedule compliance for our clients. In addition to our diverse, technical expertise, we utilize cost-effective staffing strategies and software tools to deliver your projects on schedule and on budget to accelerate your speed to market.
We provide verification support throughout all phases of project delivery including planning, design, construction, commissioning, and qualification. We are intimate with current science and risk-based methodologies and practices and implement these solutions to efficiently deliver your assets. Our verification services include the development of verification plans, user requirements, risk assessments, design review reports and C&Q protocols.
Computer System Validation
Computer System Validation (CSV) is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistency of intended performance, and the ability to discern invalid or altered records is a critical requirement of compliance in pharmaceutical manufacturing. Our CSV professionals ensure that your automated assets and systems are validated in compliance with industry regulations (e.g., 21 CFR Part 11) and guidance (e.g., GAMP 5).
Validation LifeCycle Support
Per regulatory requirements and guidance, continued process verification is a requirement of validation. The integration of development work, process conformance, and continuing verification provides assurance that the product or process will consistently remain in control throughout an entire product lifecycle. Verista can help with this validation process throughout a product’s lifecycle. We have expertise in cleaning validation, cycle development, sterilization validation, test method validation, SOP development and process validation.
Change Management & Remediation
Change management and remediation processes are critical aspects of a pharmaceutical quality system. It is becoming increasingly difficult for companies to manage the peaks of activity that occur with significant changes related to capital projects, facility and equipment maintenance, process improvements, and general regulatory requirements. Verista’s highly trained teams enable clients to augment internal teams with professionals who understand what it takes to effectively manage change and support remediation efforts.
We develop and implement verification solutions that are compliant with industry regulations and drive increased efficiency, cost reduction and schedule compliance for our clients.
Examples of Manufacturing Validation Systems
Facilities and Utilities Validation
Shop Floor Manufacturing Systems
Sterile Filling and Packaging Systems
Warehouse Management Systems
PLC/SCADA and Distributed Control Systems
Manufacturing Execution Systems
Building Management Systems