ValGenesis is an integrated Validation Lifecycle Management System (VLMS), designed to harmonize the validation lifecycle process. In addition, ValGenesis can be leveraged to harmonize the corporate quality process by connecting the disparate cornerstone applications including QMS, ERP, LIMS, MES, DMS, etc.

Harmonization of Validation Lifecycle Process

The Validation Lifecycle process consists of several different phases, including Requirement Management, Risk Assessment, Test Case Development, Traceability Management, Test Case Execution, Periodic Review and a Change Control Process.

In some organizations, many of these activities are managed within the same department and have generally been managed separately, each with their own procedures and processes.  On occasion, they adopt computerized systems for requirements management, test case management and the change control process.

However, in most of these companies, Traceability Management, Test Case Execution and the Periodic Review Process are predominantly manual and paper-based.  In many of these cases, the separate and unconnected systems lead to inconsistency, inefficiency and non-compliance. In addition, with the newer regulatory pressures and the search for greater productivity and efficiency, leaders in the life science industries have explored and experimented with different methods to harmonize these systems. Until recently, the available options have required significant compromises. ValGenesis is designed to harmonize these disconnected phases of the validation lifecycle process while, at the same time, managing all the processes in a single instance, providing a holistic overview of the validation lifecycle process, at any given time. This harmonization standardizes, enforces consistency and improves the efficiency of the corporate validation lifecycle process.

Harmonization of the Quality Process through ValGenesis

ValGenesis interfaces/integrates seamlessly with other systems including ERP, Document Management, QMS, Calibration Management Systems, LIMS, MES and others, via its out-of-the box Web services.  ValGenesis connects all these systems to provide a holistic view of the corporate quality process. Real-time access to master data and the ability to integrate quality and manufacturing processes, such as Calibration, CAPA, Deviation, Change control, batch release and others, enables organizations to operate more efficiently, with improved consistency and enhanced compliance.

Interfacing with ERP
Regulated organizations use ERP systems, such as SAP, for plant maintenance, inventory and process manufacturing, etc. Interfacing ValGenesis with the corporate ERP system helps manage all C&Q, validation, revalidation and change control requirements for GxP systems. Through this integration, ERP systems maintain the real time validation status of any system.

Interfacing with QMS
Quality Management Systems (QMS) enable regulated organizations to ensure compliance, improve quality and reduce costs by centralizing and integrating all quality processes, including the management and reporting of deviations, customer complaints, supplier quality, internal and external audits, change control and corrective and preventive actions (CAPA). Any impact on these quality processes requires re-validation, or updating,  the validation documents, as currently the validation process is generally disconnected from the QMS.  Interfacing ValGenesis with QMS enables a closed-loop quality process. All validation requirements are managed in ValGenesis and final approved validation deliverables are available at the time of closing of the quality incidents. Through a single report, auditors can now view the complete genealogy of the quality process, concurrently with the validation details.

Interfacing with Calibration Management Systems

Calibration, preventive maintenance, periodic review and revalidation activities have generally been managed separately, each with its own procedure, and some managed through computerized systems. These disconnected systems are unproductive and inefficient. Should there be any out-of-specification results identified through calibration, it may require update and revalidation of the instrument/equipment. Currently, these validation activities are managed through a manual process, or a different system.  For efficient decision-making, interfacing ValGenesis with the calibration management system provides an extremely efficient process, managing the validation and calibration data in a single repository.  Regulatory and business pressures are driving life science companies towards harmonizing calibration, validation and maintenance, improving productivity and efficiency. The consolidated calibration and validation information will be available to ERP and QMS through ValGenesis, as required.

Interfacing with LIMS
LIMS enables laboratories to manage quality control (QC) data and provide real time information regarding the stability and quality of any raw materials, or products. Some companies are managing Cleaning, Method and Process Validation Data within LIMS; however, the process documentation is managed via a manual process, causing a disconnection, which leads to an inefficient and unproductive process. Interfacing ValGenesis with LIMS manages the Cleaning, Method and Process, Validation process 100% electronically, with real time information, keeping the validation data, with process documentation, in a single source.

Interfacing with MES
Manufacturing execution system (MES) is used to manage and monitor work-in-process on the factory floor. In addition, MES systems can be used to schedule tasks, by facility, equipment, work center, machine, and/or employee skill-set. Additionally, using an MES system, equipment performance and overall equipment effectiveness (OEE) management/monitoring can be achieved. However, MES requires manual updates for the validation status of any equipment, instrument, machine or even facility, whether the entity is under revalidation, or change control, etc. ValGenesis can be interfaced with MES to avoid manual updates and maintain the closed-loop compliance process.

Interfacing with Document Management Systems
Since regulatory agencies advocate the use of a single primary source for regulatory and compliance information, regulated companies use Document Management systems to manage their regulatory and compliance information and documents, in a single repository.  As the current validation process is predominantly manual and paper-based, the approved validation documents are stored in physical, secured cabinets. Still, many life science companies, including large pharmaceutical and medical device companies, continue to conduct audits, or welcome auditors with a huge stack of hard-copy paperwork. Not only does the paperwork result in unavoidable inefficiencies, it also acts as a significant waste of time, leaving auditors and senior management officers with less data, less options and less success.

Interfacing ValGenesis with Document Management systems allows all validation documents to be kept in a single repository, as a primary source. Auditors can view the validation documents in an electronic format. In addition, this integration helps companies provide access to auditors remotely. ValGenesis acts as User Interface (UI) to manage the validation lifecycle process with document management systems.