Engineering, Validation & Software
Karya's marketplace is at the forefront of accelerating the progress of life science companies through specialized Engineering, Validation, and Software Services.
In an industry where innovation is critical, these skills are pivotal in navigating the complex terrain of product development, regulatory compliance, and market introduction.
Engineering expertise is essential for designing and optimizing the physical and technological infrastructure necessary for groundbreaking research and production. From biomedical equipment to facility design, our engineers ensure that life science companies have the robust systems needed to pioneer new treatments and technologies.
Validation services are crucial for affirming the reliability, accuracy, and consistency of the equipment, processes, and software in use. This rigorous testing and documentation process ensures that products meet stringent regulatory standards, reducing risks and safeguarding patient safety.
Engineering
A wealth of specialized expertise, diverse experiences, and technological proficiency drives the engineering services provided by Karya members.
Collaborating closely, they integrate unique perspectives to craft solutions that are efficient and innovative and precisely tailored to client's specific needs, ensuring their success. With a commitment to flexibility, these services are delivered through adaptable models that can swiftly scale up to meet project demands wherever and whenever clients require assistance.
Among the key areas of expertise are mechanical and electrical engineering, manufacturing engineering, and systems and software engineering.
Computer System Validation
Karya's validation specialists, all independent consultants affiliated with Karya's platform, employ cutting-edge techniques to validate computer systems for regulatory compliance.
They bring extensive expertise from pharmaceuticals, biotech, and other industries to ensure clients' systems are inspection-ready.
Commissioning, Qualification, and Validation
The life science consulting experts on the Karya marketplace platform offer process validation services for designing, qualifying, and continuously verifying manufacturing processes, ensuring clients maintain quality and compliance for cGMP-regulated products.
Partnering with global teams ensures each validation process step is properly executed, delivering documented evidence to regulatory agencies that systemic attention is applied and products meet necessary quality attributes.
Adopting a product lifecycle approach, Karya members help optimize product quality by identifying process variation and its impact on efficiency and quality, minimizing risks, and ensuring robust processes for reliable quality product delivery.
Cleaning and Sterilization Validation
Collaborating with organizations, Karya members develop and implement reliable and compliant validation programs.
This includes cleaning and sterilization, covering the physical and microbiological aspects of various sterilization methods.
Good Manufacturing Practices Product Lifecycle Methods
Leveraging regulatory requirements, Karya members ensure success throughout each phase of the product manufacturing lifecycle.
evaluating product analytical methods' reliability, reproducibility, and performance in cGMP environments.