Regulated Pharmaceutical and Biotech companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety. Validation has been an essential part of regulated industries for over 30 years, yet as the field continues to evolve, little has changed in the approach to validation. Over time, the traditional validation activities have centered more and more on paper-based records and documentation, which has increased immensely, leading to additional quality and compliance issues. For the most part, validation still requires a high degree of manual effort for document creation and review as well as approval, execution, tracking and reporting paper based validation activities.
ValGenesis is the first software solution in the industry that completely replaces inefficient paper based validation processes with a 100% paperless, electronic system. As a paperless electronic validation lifecycle system, ValGenesis is already being used by major global pharmaceutical companies. As a core resource for compliance-based efficient validation in regulated companies, ValGenesis is at the forefront of innovative software platforms. This can have far-reaching results in providing end-to-end validation management, thus helping companies reduce cycle time and cost savings of at least 50% during the entire validation lifecycle process. ValGenesis’ unique technology manages the entire validation process end to end paperless. In effect it dynamically tracks the validation status in real time, streamlining the process, improving communication between all stakeholders, while also ensuring compliance and enforcing consistency throughout the corporate validation lifecycle process. ValGenesis is designed to manage all types of validation processes, electronic logbook management, GxP Assets inventory management and application lifecycle management through a single instance of ValGenesis across multiple sites. ValGenesis helps to implement and enforce a uniform set of validation standards and procedures that are typically scattered in validation master plans, SOPs and policy documents across the organization.