ValGenesis for Contract Organizations
Contact Organization can be contract research or manufacturing or clinical trial. When a company transfers manufacturing and/or clinical trial and/or research functions to a contract organization, the CxO becomes subject to the same regulatory action as its client. Contract organizations work with different companies with different regulations. CxOs will be frequently audited by their clients. Having a robust quality system for CxO is not an option but a mandatory requirement.
Contract organizations that work with make medical devices is subjected to FDA's 21 CFR Part 820 and 21 CFR Part 11. Organizations contracted by medical device companies with presence in the global market are also likely to conform to ISO 13485 and ISO 9000 quality standards. Contract organizations work with pharmaceutical companies must comply with regulations including 21 CFR Parts 210-211 and 21 CFR Part 11.
Contract Organizations must address the many challenges related to quality and compliance requirements. Currently, most of the companies with multiple facilities and employees in different locations maintain separate quality systems, especially paper-based or hybrid systems. These systems are inefficient, requiring tremendous man-hours in terms of completing validation tasks which includes requirements management, traceability maintenance, document authoring with review and approval, validation execution with review and approvals, managing SOPs and other controlled documentation, leveraging users from different sites, face-to-face meetings to discuss changes, and manual search and retrieval of documents during internal and external including FDA audits.
It is a difficult task to standardize and harmonize the validation and quality process across the sites if it is a paper based manual process. Quality processes that are not connected to each other can cause delays and poor results. For example, disconnected Validation, Change control, CAPA, Deviation, Training, and other quality processes are likely to cause delays with islands of data. Integrated quality system with validation process will help to expedite the critical compliance tasks and provide a complete genealogy of any quality incidents. The quality system will be always ready for audits.
ValGenesis software solution completely replaces the inefficient paper-based validation process with a 100% paperless, electronic system. 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.
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 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.
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 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.
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.