In the regulated Life Science environment applications such as Quality Management System (QMS), Laboratory Information Management System (LIMS), Supply Chain Management (SCM), Enterprise Resource Planning (ERP), and Manufacturing Execution Systems (MES) are commonly used in the Pharmaceutical and Biotech industry. For each of these types of systems validation information is critical during their lifecycle. For example, validation status information of assets is critical in ERP systems, change request related information for each asset is critical in QMS and MES systems and data from LIMS systems is a critical requirement for process and analytical method validation requirements. With ValGenesis VLMS the challenges of manual disconnected validation processes are eliminated. Communication between departments and sites is available in real-time strengthening your validation process.
Through ValGenesis VLMS business systems can be interfaced either directly or via an integration layer resulting in centralized information and avoidance of data silos and islands of information..
ValGenesis Integration Technology
ValGenesis offers a comprehensive set of integration technologies built on top of the ValGenesis Gateway which dramatically reduces the effort associated with integration. ValGenesis provides multiple options to integrate with other systems by leveraging standard technologies like SQL, Web Services and APIs. For our customers the ValGenesis Gateway provides a proven integration with any enterprise application or system. The ValGenesis Gateway delivers a cost-effective solution to integrate quickly.
The following Integration Technologies are available with ValGenesis:
- SAP Integration through XI/PI
- Interfaces with Document Management Systems (DMS)
- Interfaces with Quality Management System (QMS)
- Interfaces with Test Automation Tools – HP QTP and MS VSTS
- Interfaces with Laboratory Information Management System (LIMS)
- Interfaces with Learning Management Systems (LMS)
- Synchronize user information through Active Directory
- Single sign-on integration
- Lookup master data
- Automatically pull and push data
Functions of ValGenesis Gateway
- Reduce the time and cost of double entry by looking up assets and process information directly from your existing production systems.
- Eliminate the quality gap by automatically converting defects identified by your production systems into workflow based nonconforming material events in ValGenesis.
- Prevent poor data quality by selecting from existing data in external systems, such as product, supplier, customer, etc.
- Shorten your inventory cycles by automatically releasing products put on hold in your production systems when the appropriate investigation and release phases have been completed in ValGenesis.
- Minimize risk in product releases by scanning systems for open quality issues prior to release and automatically preventing product releases if issues are found.
ValGenesis is a certified SAP partner and has developed integration scenarios specifically for SAP implementations. These integration scenarios enable the ValGenesis Gateway to compliment an organization’s existing SAP solution, and provide additional integration tools to ValGenesis’ already robust and proven integration options.
In most of the scenarios, assets (instrument, equipment, computer systems etc.) are managed within SAP. Through this integration equipment details will be dynamically populated in ValGenesis through the validated interface. The validation process is managed within ValGenesis VLMS and once the asset (instrument, equipment, computer systems etc.) is validated the status of the asset will be updated in SAP. Once all the validation tasks have been completed and reviewed the validation status is updated and performance indicators are passed to SAP for aggregate analysis to allow for better business decisions.
Interfaces with Document Management Systems
ValGenesis provides validated connectors for commonly used document management systems. This interface provides an end-to-end, secured, 100% paperless validation lifecycle management solution plus central storage of validation documents and data provided by these two complementary systems.
This interface will seamlessly provide global access, retrieval and storage of corporate validation data and documents generated by ValGenesis within the corporate document management system. This leverages real-time reporting and search capabilities inherent to most document management systems for validation data and documents. Furthermore, document management staff can apply federated retention policies to unify management practices across all documents and record types throughout their organizations, ensuring consistent compliance to regulatory requirements.
Interfaces with Quality Management System:
Quality incidents, including deviations, CAPAs and change controls are triggered by corporate quality management systems, quality audits, customer complaints or some other source. These quality incidents can trigger validation requirements during the resolution process. Typically, the validation process is managed manually through paper or through a hybrid of paper and electronic systems. Typically there’s a disconnect between quality incidents and validation processes that are triggered, making data collection time consuming and laborious. Without a system to connect the dots, critical information may fall through the cracks and the root-cause investigation is likely to be unreliable.
Interfacing ValGenesis with Quality Management Systems provides a closed-loop quality process with a complete genealogy of the quality process and the impacted validation/controlled documents. The need to search for data in real-time is accommodated by a wide range of query and search capabilities. Powerful reports with graphical analyses can be generated within seconds using a centralized repository. This enables users to search across all relevant database areas for recurring quality problems. For example, by entering a product number one can use a single query to find every non-conformance, deviation, corrective action, investigation and validation associated with this product. Furthermore, this useful information can provide the necessary reports and metrics to ensure proper analysis.
Interfaces with Test Automation Tools:
Automated testing tools such as HP’s Quick Test Professional (QTP) or Microsoft’s Visual Studio Team System (VSTS) are designed to allow users to program sophisticated tests that bring out hidden information from software applications. With automated testing tools, more tests can be run in significantly less time with fewer resources. Leveraging automated testing tools for validation requirements will greatly reduce validation cycle time and cost. However, on their own, test automation tools do not meet the regulatory compliance requirements regarding controlled workflows and content management, audit trails, accountability and e-signatures.
The integration of ValGenesis VLMS and automation testing tools leverages the power of automated test engines with the compliance controls to meet stringent regulations. The integrated system provides automated software validation that is fully compliant for the Life Sciences industry.
In addition, critical phases of the validation process including planning, requirements management, traceability, risk assessment, periodic review and change control will be harmonized with an automated validation process. Approved validation documents generated through an automated validation process are stored in the Library module in ValGenesis VLMS or can be migrated into a corporate document management system with all the necessary security to ensure the integrity of the documents.
Interfaces with LIMS:
Laboratory Information Management Systems (LIMS) are software applications for QC and analytical laboratory use. They are designed to administer samples and acquire/manipulate data and report results. Process, method and cleaning validation processes require documentation of tests and comparison of the test results against the specification limits, in addition to documenting the process. The ValGenesis VLMS interface with LIMS systems provides a mechanism to share sample test data with documented validation process information. This significantly aides in the management of process, cleaning and method validation processes completely electronically and 100% paperless.
Interfaces with Learning Management Systems:
The regulated Life Science industry must ensure that employees have the right training to perform their assigned tasks. Employees should be qualified on the basis of their education, training or experience in systems and processes. Training records should be maintained and available as mandated by regulatory requirements.
ValGenesis can be interfaced, through rich web services, with corporate learning management systems to allow only qualified users to conduct specific validation tasks. This will ensure compliance in the corporate validation process. In addition, this integrated approach to managing validation and change control with learning management enables impacted users to retrain in the changed system and/or process by alerting them and creating the retraining requirements.
Synchronize User Information through Active Directory
ValGenesis provides seamless integration with Active Directory (AD) with single or multiple domains.
Enabling Active Directory integration with ValGenesis is a simple, wizard driven process. Integration with AD eliminates the need to manage separate user lists and passwords, dramatically reducing the need for IT intervention and thereby lowering the total cost of ownership. When an IT administrator creates a new user account, that user is automatically available in ValGenesis for access configuration to the appropriate documents and functions in the system.
ValGenesis supports single sign-on through Okta, an enterprise grade identity management service for web-based applications. With single sign-on, users are able to login to their network and the system will automatically authenticate the user in ValGenesis based on the login credentials provided. Sharing user data between Okta and ValGenesis is achieved through the user management system inherent to Okta. The user management system manages data sharing and allows administrators to identify the users that will have access to ValGenesis. If changes need to be made at a later time, the user management system can import the updates from ValGenesis or, if the updates were made in Okta, the user management system can push the updates to the ValGenesis user table. This keeps the user data in synch between ValGenesis and the enterprise identity management systems.
When a ValGenesis user successfully authenticates with Okta and tries to access the ValGenesis instance, a token is sent to the instance authorizing the user so they do not have to sign in again. In addition to single sign-on, ValGenesis supports the use of e-signatures through Okta.