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 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation. Over time the traditional validation activities have become centered on documentation, which has increased tremendously and led to additional quality issues. For the most part, validation still requires a high degree of manual effort for tracking and reporting, and the execution of most validation protocols takes place on paper.

ValGenesis is the first software solution in the industry that completely replaces the inefficient paper-based validation process with a 100% paperless, electronic system. ValGenesis is a system of Validation records for major global pharmaceutical companies. As a core resource for compliance-based validation in regulated companies, ValGenesis is at the forefront of innovative software platforms, with far reaching results that provide end-to-end validation management, helping companies save up to 40-50% in time and cost across the validation process. ValGenesis’ unique technology manages the entire validation process end to end, dynamically tracking validation status in real time, streamlining the process, improving communication between all stakeholders and ensuring and enforcing compliance and consistency throughout the whole corporate validation process. ValGenesis is modularized, with modules for Planning, Risk Assessment (FMEA), Requirements Management, dynamic Traceability Matrix creation, Document Authoring, paperless Electronic Execution, Periodic Review scheduling and Content Management. ValGenesis helps to implement and enforce validation standards and procedures that are typically buried in validation master plans, SOPs and policy documents.

Assets Management

Pharmaceuticals and Biotechnology industries etc. can efficiently handle their unique asset management processes with real time validation status using ValGenesis Asset Management function.

Computer System Validation

ValGenesis is designed to manage the complete validation lifecycle for computerized systems. Life Science companies can replace tedious paper based manual system with an electronic, automated validation lifecycle management system that supports the risk based approach and makes the CSV process 100% electronic.

Equipment Validation

Equipment Validation and qualification is a time consuming process that has the potential to delay the release of products to the market.  Life Science companies can replace tedious paper or manual system with an electronic validation lifecycle management system that makes the equipment validation process 100% electronic.

Process Validation

The FDA describes in the latest draft process validation guidance that, “In all stages of the product lifecycle, good project management and good archiving that capture scientific knowledge will make the process validation program more effective and efficient. These practices should ensure uniform collection and assessment of information about the process, reduce the chance for redundant information gathering and analysis, and enhance the accessibility of such information later in the product lifecycle.”  It is almost impossible to achieve this requirement without using a software platform in order to access information quickly throughout the product lifecycle. Life Science companies can enforce the process validation requirements through ValGenesis.

Method Validation

Method validation is the process of establishing documented evidence that a method is suitable for its intended use. Life Science companies can replace inefficient paper manual system with an electronic validation lifecycle management system that makes the equipment validation process 100% electronic.

Cleaning Validation

The current cleaning validation approach, which relies on paper and manual systems, is time consuming and inefficient as documents are needlessly recreated and tedious manual tasks are performed on a routine basis. Life Science companies can replace tedious paper or manual base cleaning validation process with an electronic, automated validation lifecycle management system that supports the risk based approach and makes the cleaning validation process 100% electronic.

Facility Commissioning and Qualification

ValGenesis manages facility commissioning and qualification projects. Unlike manual paper system, ValGenesis allows engineering and validation professionals to control and track the status of each equipment or system from the initial requirements through risk assessment, traceability matrices generation and qualification.

Automated Periodic Review Process

Periodic review schedules are created and routed for approval through ValGenesis. Approved periodic review and revalidation schedules are automatically written to a central validation calendar. The validation schedule calendar can be viewed by the week, month or year. Selected Groups (groups selected at the time of schedule creation) will be alerted of upcoming or delayed periodic review and revalidation tasks automatically through corporate email system.

Change Management Process

ValGenesis system provides a closed loop change management process; the process begins with the initiation of the Change request, which may from an internal member of the company.  In ValGenesis, change control and validation are intertwined in order to achieve a completely closed loop quality management process.  The change control process with ValGenesis follows GAMP 5.0 guidelines while providing users with the flexibility to configure the change management process to meet their existing business processes.