Implementation of FDA’s Design Control requirements (21 CFR 820.30) changed an entire medical devices and diagnostic industries. The Quality system requirements define the approach to medical device validation, product design, manufacturing process, and test method validation studies. Validation studies must demonstrate that product design, process, test methods, requirements and specifications determined during development can be met in the environment the product to be used.

Medical device validation is a complex process that must be completed and documented before releasing the products into market to meet the strict regulatory requirements including FDA. Success in the Medical Device industry requires adherence to applicable FDA regulations - ISO 13485, ISO 14791, 21 CFR 820 and 21 CFR Part 11. The FDA believes through careful design and software validation of the process and process controls, a medical device manufacturer can establish a higher degree of confidence. Successfully validating a process will reduce the dependence upon intensive in-process and finished product testing.

The current validation process is predominantly manual and paper based. The paper-based manual validation processes, stifle innovation, cause compliance risks and compromise a medical device firm’s ability to bring products to the market on time. Inefficiencies in the validation process cost regulated manufacturers millions of dollars annually, mainly attributed to the use of paper, or paper/hybrid.

ValGenesis completely replaces the inefficient paper-based validation process with a 100% paperless, electronic system. 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.

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.