Validation Services

Since 2004, HepTronik has provided real-world experience in the GLP, GCP, and GMP environments, working with Computer Systems, Automation, and Facilities/Utilities/validation for our many clients. Our experience in Pharmaceutical, with a focus on compliance, quality, and validation. We offer a variety of Validation Services to Life Sciences clients including:

• Big Pharma
• Specialty
• Biotech
• Device
• Generic

We employ Validation, Quality, Project Management, and Operations; and, with an our scientists, engineers, pharmacists, and PhDs are respected throughout the industry for their knowledge and expertise.

Computer Systems Validation:

HepTronik has performed computer system validation since our inception in 2004. Our methodology is easily adaptable and interchangeable with current industry standards such as GAMP4, PDA and proprietary corporate policies no matter the size of your organization. Whatever your validation needs - outlining a validation plan, writing test scripts, developing a comprehensive system validation or managing an enterprise-wide program – HepTronik has the flexibility, resources, and expertise to deliver a higher quality solution.

Validation:Computer Systems Validation (CSV) has become a major area of investment as well as ongoing discussion in the regulated industries. Many users and developers believe that the validation process adds a significant overhead and contributes minimally to the quality of the system and the integrity of its data. The most common cause for poor CSV efforts is the inefficient execution of CSV projects because of varying interpretations of regulatory requirements that focus attention on the style and format of CSV documentation, rather than the ultimate quality of the system.

In light of FDA’s evolving views regarding the value of implementing risk-based approaches , organizations now have the opportunity to reevaluate, improve, and optimize their system life cycle (SLC) and validation methodologies and thus produce better systems more effectively and more efficiently, while ensuring patient safety, data integrity and regulatory compliance.

How HepTronik Can Help : HepTronik's computer system validation and 21 CFR Part 11 services formally incorporate a business process-driven, risk-based approach to compliance as an integral part of the SLC to ensure compliance with regulatory requirements. HepTronik consultants have expertise in regulatory requirements, CSV methodologies, the technical aspects of computer system development, and the surrounding business processes. The team's comprehensive knowledge and experience are essential for effective and efficient scaling and execution of CSV activities. Our senior consultants are experts in managing and coaching developers, users, and validation teams to ensure successful conclusion of system implementation and validation efforts. HepTronik's CSV services cover the full system life cycle, from requirements analysis through system retirement, and are fully integrated with complementary business and regulatory compliance services.