Life Sciences Expertise

Validation& Qualification

At VectorPath Technologies, we understand the critical role that computer software, equipment, and processes play in life sciences-regulated environments. We provide end-to-end validation services that ensure your systems comply with industry regulations, from methodology development to end-user training.

Our team of experts follows best practices and leverages test automation capabilities to reduce your implementation and validation time. We can help you transition from traditional Computer System Validation (CSV) to a more modern Computer Software Assurance (CSA) approach, which can improve your quality and efficiency.

Trust us to provide full-service validation and support to keep your systems compliant and help you achieve your business goals.

As companies are adopting SaaS, PaaS, and IaaS at an exponential rate, VectorPath Technologies helps clients scale their CSV SOP and execution infrastructure to account for these changes. They also assist clients in validating AI & ML models, upgrading their SDLC policies to SDLC, and integrating Data Integrity and CSV programs to eliminate the silos.

Validation Services for Life Sciences GxP Environments:

VectorPath Technologies provides comprehensive validation services for systems, equipment, and processes in various life sciences GxP environments, whether on-premises or cloud-based. We have expertise in qualifying, verifying, and validating a wide range of systems, including blood and plasma systems, clinical systems, laboratory systems and equipment, and manufacturing systems and equipment. Additionally, we offer validation services for regulatory publishing and submissions, software as a medical device, and UDI and serialization.

If you have any questions about how we can help with your specific GxP system requirements, please fill out our contact form, and we will review your request. With our validation best practices and test automation capabilities, we ensure that your systems are compliant, and our expertise significantly decreases your implementation and validation time.

Data Integrity

Effective data management and data integrity are crucial components of any organization, but they are particularly important for highly-regulated life sciences companies. Inaccurate or incomplete data can compromise product quality, safety, and efficacy, leading to serious consequences including penalties and product removal from the market. At VectorPath Technologies, we offer comprehensive data integrity assessments and tailored improvement plans that address policies, training, and culture to ensure your quality system is fully integrated with best practice data integrity principles. We can also help you comply with regulatory requirements such as 21 CFR Part 11 by providing digital signature collection and storage, audit trails and FDA compliance, and GxP-compliant cloud data software and training. Contact us to establish a data integrity program that fits with your organization's risk tolerance and priorities.

GxP Cloud Managed Services

At VectorPath Technologies, we understand that life sciences companies face unique IT challenges that can impact regulatory compliance as they progress through the R&D, clinical trials, and commercialization phases. Our goal is to help your organization focus on what matters most - getting your life-saving therapies to market - by taking on the burden of IT and compliance management.

Our team of regulatory and technical experts has been working exclusively with biotech, pharma, medical device, and CROs/CMOs for over two decades, and we have the knowledge and experience to help bridge the gap between your quality and IT teams. With our managed services, you can offload compliance and technology management to us, and we'll ensure continuous cloud compliance of your entire tech stack.

Our services are bundled into subscription models or fixed fees to control your IT spending while maintaining compliance. We offer a range of services, including Cloud Assurance Continuous Compliance, GxP Managed Services, GxP Workflow and Process Automation, Technical Managed Services, Cybersecurity, Content and Data Governance, and Quality Management Framework. Let us take care of the technical details so you can focus on what you do best –an innovation that saves lives.

GxP Training & Education

At VectorPath Technologies, we understand the importance of staying up-to-date with the constantly evolving regulatory landscape. Our customized training programs are designed to ensure that your internal teams and external partners are equipped with the knowledge and skills necessary to remain compliant with industry regulations. We work with you to develop training programs that meet your specific needs and goals, whether it's a one-time course for a new team or recurring annual training requirements.

Our compliance training courses cover a range of topics, including GxP, risk management, design control, quality management systems, and more. We offer on-site and remote training options, and our pricing is based on the number of courses, attendees, and sessions to ensure cost-effectiveness.

Our GxP training programs include hands-on workshops and comprehension tests to measure training effectiveness, and we can customize training materials to align with your organization's processes and procedures. Additionally, we include staff learning in our programs to ensure that everyone on your team is wellinformed and up-to-date.

Choose VectorPath Technologiesas your trusted partner for regulatory compliance training and ensure that your team is equipped to navigate the complex and ever-changing regulatory landscape.

Audits & Risk Assessments

Audits

For many years, VectorPath Technologies has been conducting audits and assessments in the biotech, medical device, and pharmaceutical industries. Our team of highly qualified auditors follows the U.S. Food and Drug Administration (FDA)’s Quality Systems Inspection Technique to ensure that your regulatory requirements are met and that your Quality System is operating in a state of control.

Our approach to regulatory audits is focused on investigating specific systems and processes to ensure that they meet industry standards and regulatory requirements. We identify any gaps and observations in systems, processes, and documentation, and we verify that processes are documented and being followed while ensuring that GxP records, objective evidence, and data integrity are adequate. If you need help ensuring compliance with regulatory requirements, please contact us through our website.

At VectorPath Technologies, we understand that knowledge is crucial for maintaining security. Our team of highly experienced auditors follows the Quality Systems Inspection Technique recommended by the U.S. Food and Drug Administration (FDA) to ensure your regulatory requirements are met, and your Quality System is operating in a state of control.

Our audit services cover a range of areas, including software vendor and supplier qualification, mock audits, GxP audits, audit readiness, and auditing-as-a-service. We offer single audit services, staffing augmentation, and managed services to meet your specific needs. Additionally, our assessment services take a holistic approach to your regulatory requirements, and we provide recommendations for remediation and prioritize them based on your unique circumstances.

At VectorPath Technologies, we also provide remediation services to help address any findings from our assessments. Contact us today to see how we can help your organization.