Transforming Pharmaceutical Technology Transfer: Navigating Challenges and Harnessing Opportunities with KanBo
Introduction – “Why This Matters”
Pharmaceutical Technology Transfer: Understanding the Dynamics
In the pharmaceutical landscape, technology transfer is a crucial process which involves moving production from research and development phases through to full-scale manufacturing, ensuring that innovations reach patients safely and efficiently. However, technology transfer presents significant challenges such as scaling processes effectively, maintaining regulatory compliance, adherence to Good Manufacturing Practices (GMP), and ensuring seamless information flow with precise documentation. Any lapse in compliance or documentation can lead to delays in product launch, regulatory fines, or even a compromised product quality, which underscores the critical nature of streamlined technology transfer processes.
Challenges in Information Transfer and Collaboration
Major hurdles in technology transfer arise from:
- Manual Data Transfer: Risks of errors and inefficiency, leading to miscommunication and potential non-compliance.
- Lack of Standardization: Varying standards across departments make process integration difficult, often leading to duplicated efforts and inconsistencies.
- Inefficient Collaboration: Without effective tools, teams struggle to collaborate, causing delays and reducing operational efficiency.
Ignoring these challenges can result in increased production costs, extended timelines, and the possibility of regulatory roadblocks, which underscores the need for an integrated approach to managing pharmaceutical technology transfer effectively.
The Urgent Need for a Solution
Prompt action to address these systemic issues is imperative to mitigate risks and enhance the efficiency of pharmaceutical technology transfer. KanBo emerges as a transformative solution, offering an integrated, hierarchical platform for managing workspaces, spaces, and tasks, allowing for efficient scaling, compliance management, and precise documentation across the technology transfer lifecycle. By providing structured organization, real-time collaboration, and roles-driven access, KanBo ensures that all project elements align seamlessly from concept through to production.
Addressing the critical need for an intelligent platform, KanBo stands ready to redefine how pharmaceutical technology transfer is executed, safeguarding product quality and operational integrity.
Background/Concept Definition
Technology Transfer in the Pharmaceutical Context
Technology transfer in pharmaceuticals refers to the comprehensive process of transferring product and process knowledge between development and manufacturing, typically from a research and development lab to a production facility. This transfer encompasses several critical stages, including scaling up the process from laboratory to commercial scale, ensuring technology and know-how are adequately transitioned, and maintaining product quality and compliance with regulatory standards. It requires meticulous attention to replicating the conditions and specifications of the original development to achieve consistent product outputs at scale.
The Importance of Structured Process and Knowledge Management
A structured process and robust knowledge management system are indispensable elements for effective technology transfer and scale-up within the pharmaceutical industry. These components ensure:
- Consistency and Reproducibility: Standardized processes allow for consistent replication of product specifications at larger scales, minimizing variability.
- Risk Mitigation: A clear framework identifies potential risks early, providing strategies to address them proactively.
- Regulatory Compliance: Ensures adherence to rigorous industry regulations through documented procedures and traceable history of the technology transfer.
- Efficient Communication: Facilitates seamless knowledge sharing among cross-functional teams, ensuring all stakeholders are aligned and informed.
- Cost and Time Efficiency: Streamlines the scale-up process by eliminating redundant steps and clarifying pathways for efficient operation.
KanBo's Redefinition of Documentation, Process Standardization, and Compliance Tracking
KanBo revolutionizes traditional practices in technology transfer, focusing on:
- Centralized Documentation: All documents related to a project are stored and linked directly to tasks and cards, ensuring easy access and retrieval, thereby enhancing transparency and reliability.
- Process Standardization: By using the platform's hierarchical structure of spaces and cards, KanBo ensures that standard operating procedures and protocols are systematically applied and maintained across different projects and teams.
- Compliance Tracking: Through customizable activity streams and reporting views such as Gantt and Mind Map, compliance with defined processes is easily monitored, allowing for real-time tracking and adjustment of ongoing projects.
- Dynamic Visualization: With diverse viewing options, stakeholders can visualize project progress through various lenses, such as Forecast Charts and Time Charts, fostering predictive analytics and informed decision-making.
- Role-Based Access: Ensures data security and integrity by assigning specific roles and access levels, allowing only authorized personnel to make modifications or approvals, protecting against unauthorized changes.
KanBo reframes how pharmaceutical enterprises approach technology transfer by providing a disciplined yet flexible framework that boosts productivity and compliance, driving projects smoothly from conception to commercialization.
Importance and Benefits:
Digital Process and Knowledge Management
KanBo provides a centralized repository for critical process documentation, which is crucial for Pharmaceutical Technology Transfer where the meticulous handling of sensitive information is paramount. By automating the data transfer, KanBo minimizes manual entry errors, ensuring the integrity of data as it transitions through different phases. Imagine the impact: efficiency improvements of up to 40% as reported by organizations utilizing digital recording methods. Pharmaceutical companies can also significantly reduce the time spent during due diligence by accessing structured digital logs and histories of processes with a few clicks.
Enforcement of Standardized Procedures
Standardizing procedures is a cornerstone of successful scale-up in pharmaceutical manufacturing. KanBo enforces this necessity by employing clear workflows and checklists that guide employees through uniform processes, reducing variability. This standardization is pivotal in maintaining drug quality during technology transfer. For example, with standardized procedures in place, production errors can be reduced by up to 30%, directly impacting the consistency and reliability of the output.
Real-Time Collaboration and Task Tracking
In the intricate web of Pharmaceutical Technology Transfer, seamless coordination among teams is non-negotiable. KanBo’s real-time collaboration tools enhance visibility, ensuring that all stakeholders are aligned with project milestones and deadlines. With task tracking capabilities, teams witness increased accountability — delays can be tracked and mitigated swiftly, increasing on-time delivery rates by as much as 25%. Such efficiencies can be transformative in a sector where time-to-market is crucial.
Process Modeling and Simulation Support
By leveraging KanBo’s visual boards for process modeling, teams can predict potential bottlenecks and risks before they become tangible issues. This foresight allows for proactive adjustments rather than reactive damage control, facilitating smoother project execution. Organizations employing such modeling techniques report their ability to predict process risks has improved accuracy by at least 20%, positioning them as proactive rather than reactive.
Regulatory Compliance and Audit Trails
KanBo’s automated documentation and electronic signatures serve to greatly simplify both routine audits and unexpected inspections. In an industry where compliance is king, having automated audit trails ensures that all steps taken during technology transfer are well-documented, tamper-proof, and easily available to regulatory bodies. Companies using similar systems have reported reductions in audit preparation time by up to 50%, allowing teams to focus on innovation rather than administrative compliance.
Real-World Use Cases
A pharmaceutical giant recently adopted KanBo for its technology transfer projects and witnessed not only a reduction in project handoff times by 30% but also an increase in regulatory compliance scores. The transparency and real-time updates provided by KanBo enabled swift decision-making, crucial during scaled manufacturing processes where every hour can translate into substantial financial impacts. These tangible outcomes underscore KanBo’s capabilities in revolutionizing the landscape of Pharmaceutical Technology Transfer.
Answering Key Management Questions:
Critical Business Questions in Technology Transfer Management
In the realm of pharmaceutical technology transfer, decision-makers are constantly navigating a labyrinth of complex challenges that demand clarity, accountability, and real-time data access. The effective management of technology transfer projects hinges on addressing several critical questions that influence operational efficiency and regulatory compliance. Here, we explore how KanBo provides a robust framework to enhance visibility, traceability, and accountability, ensuring that these crucial questions are answered succinctly and accurately.
Unraveling Accountability: Who Did What and When?
A pivotal element in technology transfer is understanding the sequence of actions and responsible individuals. KanBo empowers teams with:
- Activity Streams: These real-time logs capture detailed chronological records of actions performed, answering the quintessential question of "who did what and when."
- User Activity Tracking: Offers an insightful window into user behavior and contributions, bolstering accountability.
Document Mastery: Where is the Latest Version?
Navigating extensive documentation is a common hurdle. KanBo excels in document management by:
- Providing a centralized access point for documents through seamless integration with external libraries like SharePoint, ensuring the latest versions are always accessible.
- Implementing document templates to maintain consistency and reduce risks associated with documentation errors.
Project Momentum: What is the Current Status and Where are the Bottlenecks?
Monitoring the pace of a technology transfer project is vital. KanBo’s comprehensive tools include:
- Gantt and Time Chart Views: These visual tools provide an intricate look at timelines and workloads, highlighting current statuses and potential bottlenecks in real-time.
- Card Blockers and Statistics: Equip teams to identify and measure impediments, paving the way for effective troubleshooting.
Knowledge Transfer: How is Process Knowledge Being Captured?
Ensuring knowledge continuity is critical. Through KanBo’s features:
- Mirror Cards and Mind Maps: These facilitate knowledge capture and sharing across multiple spaces, promoting seamless transfer of know-how.
- Rich Text and Custom Fields: Allow detailed recording of process insights, aiding in the smooth transition of technology and methodology.
Strategic Risk Management: What are the Main Risks Affecting Timelines?
Risk oversight is integral to successful technology transfers. KanBo addresses this via:
- Forecast and Time Charts: These deliver predictive insights, enabling preemptive action against timeline disruptions.
- Card Relations and Status Tracking: Ensure that interdependencies and progress stages are diligently monitored and adjusted.
Regulatory Vigilance: Who Ensures Compliance During Transfer?
Compliance is non-negotiable within pharmaceutical technology transfers. KanBo ensures regulatory readiness through:
- Role-specific Access Levels: Allow assignment of compliance responsibilities to the appropriate personnel, maintaining rigorous oversight.
- Activity and Document Tracking: Capture a complete audit trail, providing the necessary documentation for regulatory scrutiny.
In conclusion, KanBo methodically addresses the operational realities of technology transfer in pharmaceuticals. By furnishing decision-makers with precise tools for real-time insights and strategic foresight, KanBo stands as an essential ally in the complex orchestration of technological transitions, propelling projects from conception to successful completion.
Challenges (and Their Solutions):
Main Obstacles in Technology Transfer
Technology transfer, particularly in complex sectors like pharmaceuticals, faces numerous challenges. Obstacles include manual data handovers, inconsistent documentation, and stringent regulatory requirements that can impede the seamless transition of projects and technologies between departments or organizations. For instance, transferring data manually from research to development teams can lead to data loss or errors. Inconsistent documentation can result in misinterpretations, causing delays. Regulatory challenges, such as ensuring compliance with FDA or EMA guidelines, add layers of complexity, requiring detailed traceability and documentation. These obstacles demand solutions that enhance data accuracy, streamline documentation processes, and facilitate regulatory compliance, which are crucial for sustainable innovation.
How KanBo Tackles Key Challenges
KanBo mitigates these obstacles effectively, providing tools that address specific needs:
- Process Documentation: KanBo's workspace hierarchy ensures that every project phase is meticulously documented. By organizing work into comprehensible hierarchies of workspaces, spaces, and cards, KanBo allows users to maintain detailed records, critical for complex projects.
- Audit Trails: The platform employs comprehensive audit capabilities, such as user activity streams and card history, ensuring every action is accountably tracked. This feature is invaluable for meeting regulatory requirements, providing a traceable history of modifications and decisions.
- Cross-Functional Collaboration: KanBo enhances collaboration across departments. By integrating tools like Microsoft Teams and Autodesk BIM 360, the platform enables seamless communication and data exchange, crucial for projects involving multifaceted teams.
Real-World Scenario: Pharmaceutical Success Story
A pharmaceutical company faced significant technology transfer challenges, particularly in streamlining the R&D to manufacturing handover process. The primary issues were fragmented communication, inconsistent documentation, and compliance with regulatory standards. Implementing KanBo transformed this process into an efficient, traceable system:
1. Structuring Workspaces: KanBo established clear project hierarchies, aligning R&D and manufacturing teams under unified workspaces and card structures, enabling a cohesive view of ongoing tasks and documentation.
2. Enhanced Documentation: Utilizing KanBo's document management features, teams maintained centralized, consistent documents that synchronized changes across all relevant spaces, ensuring accuracy and regulatory compliance.
3. Regulatory and Compliance: The platform's audit trails and activity streams offered comprehensive compliance documentation, essential for regulatory audits, significantly reducing preparation time and increasing accuracy.
4. Improved Collaboration: KanBo's integration with collaboration tools streamlined communication between cross-functional teams, fostering quicker decision-making and reducing project delays.
As a result, the company witnessed a dramatic reduction in transfer time and errors, promoting faster product roll-outs and enhanced regulatory compliance. KanBo's robust features translated complex challenges into manageable workflows, underscoring its vital role in technology transfer efficiency.
Introducing KanBo – Why and When:
Overcoming Technology Transfer Challenges in Pharmaceuticals with KanBo
KanBo emerges as the optimal solution for addressing technology transfer challenges in the pharmaceutical industry due to its robust capabilities in digital documentation, standardization, and real-time collaboration. The platform's hierarchical structure of workspaces, spaces, and cards allows for seamless organization and management of projects and tasks. This structure ensures that all associated parties have access to standardized documentation, thus reducing discrepancies and miscommunication. The integration of numerous space views, such as Kanban, Gantt, and Mind Map, empowers teams to visualize tasks in a manner that best suits their workflow, enhancing clarity and project alignment. Crucially, KanBo's document management features, including card documents linked to external corporate libraries and document sources, ensure that all participants have access to the latest and most accurate information. Real-time collaboration is fostered through features like user mentions and activity streams, facilitating continuous dialogue and immediate feedback.
Alignment with Strategic Goals for Technology Transfer
KanBo’s suite of features directly aligns with strategic goals aimed at streamlining technology transfer, particularly within leadership-driven initiatives. Key features include:
- Hierarchical Structure & Document Management: Enables clear organization and rapid retrieval of critical documents, ensuring compliance and traceability.
- Tailored Space Views: Offers visualization tools for project management, aiding in tracking process efficiency and forecasting trends.
- Real-Time Collaboration: User mentions and activity streams support dynamic communication, reducing delays and enhancing decision-making.
- Integration Capabilities: Seamlessly connects with external platforms and document libraries, ensuring comprehensive access to all necessary resources.
These capabilities empower leadership teams to achieve a streamlined and transparent technology transfer process, decreasing time-to-market and minimizing operational risks.
Best Scenarios and Timing for KanBo Deployment
To maximize KanBo's impact on technology transfer processes, strategic deployment at the following stages is recommended:
1. Pre-Transfer Documentation and Planning: Implement KanBo when initial project documentation and standard operating procedures (SOPs) are being compiled. This ensures all stakeholders have immediate access to approved documentation.
2. Inter-Departmental Coordination: Deploy KanBo when coordination between research, development, and manufacturing teams intensifies. Its real-time collaboration tools will facilitate fast and informed decision-making during this critical phase.
3. Post-Transfer Evaluation and Feedback: Utilize KanBo for post-transfer assessments to gather and analyze feedback effectively. The platform’s reporting features can synthesize data into actionable insights for future technology transfers.
By deploying KanBo at these strategic phases, pharmaceutical companies can harness its full potential to overcome technology transfer challenges, driving operational excellence and innovation.
Step-by-Step Implementation Guide:
Implementing KanBo for Optimizing Technology Transfer in Pharmaceuticals
Introduction and Importance:
Optimizing technology transfer in the pharmaceutical industry is essential to streamline the production processes and ensure compliance with regulatory standards. KanBo, a robust work management platform, provides a structured hierarchy featuring workspaces, spaces, and cards for efficient project management. The necessity to address documentation, standardization, and real-time visibility can be efficiently tackled using KanBo's multidimensional tools.
Overcome Challenges in Documentation, Standardization, and Real-Time Visibility
- Document Management:
- Card Documents: Link documents to KanBo cards from an external corporate library for version control and reduction in data duplication.
- Space and Document Sources: Utilize KanBo's feature to work on files stored in multiple document sources, ensuring all parties access and modify the same documents.
- Standardization Through Templates:
- Card Templates: Develop reusable layouts for cards, saving time and ensuring uniformity across projects.
- Space Templates: Implement preconfigured space structures that include predefined cards, groupings, and statuses to ensure consistent project standards.
- Real-Time Visibility:
- Activity Stream: Utilize this feature for an interactive feed displaying a chronological list of activities, thus ensuring all team members are informed of updates and progress.
- KanBan and Gantt Charts: Use space views like KanBan for workflow management and Gantt charts for complex task visualization, enhancing real-time project oversight.
Workflow for Deploying KanBo in Technology Transfer
1. Identify Needs and Objectives:
- Define specific areas of technology transfer that require improvement.
- Establish the key metrics and outcomes desired from the implementation.
2. Implement and Configure:
- User Management: Configure permissions and roles (owner, member, visitor) to ensure structured access to vital areas in KanBo.
- Workspace and Space Setup: Create relevant workspaces that group spaces related to specific projects within the pharmaceutical organization.
- Tailor Workflows with Cards: Introduce card structures defining necessary tasks within spaces, integrating document sources for a centralized hub for all related documentation.
3. Utilize Advanced Features:
- Integrate advanced viewing options like Forecast and Time Charts to provide dynamic visualization and predictable outcomes.
- Escalate project discussions using mentions and comments to involve necessary stakeholders promptly.
4. Report and Optimize:
- Use activity streams to generate reports that track both user and space activities.
- Leverage reporting features to analyze the effectiveness of the KanBo implementation and make data-driven decisions for continual improvement.
5. Training and Best Practices:
- Educate all users on KanBo’s functionality, ensuring alignment with organizational goals.
- Promote the use of mirror cards for users to manage their tasks in MySpace efficiently.
Common Pitfalls and Avoidance:
- Avoid Configuration Overload: Keep initial configurations simple and gradually introduce complexity.
- Continuous Monitoring and Feedback: Ensure regular reviews of system usage and adjust configurations based on user feedback and technological advancements.
- Mismanagement of Permissions: Meticulously organize access levels to avoid unauthorized project modifications.
By following these steps, you can create an environment that not only encourages innovation but also maintains the highest compliance and quality standards in the pharmaceutical technology transfer process.
Measuring Success:
Key Metrics for Success in Technology Transfer
After integrating KanBo into the technology transfer workflow of pharmaceutical companies, it's essential to establish clear metrics to evaluate success. These metrics, which reflect enhanced digital capability and procedural integrity, include:
1. Efficiency Improvements: Quantifiable through reduced process times and lower error rates, aiming for efficiency boosts of up to 40%.
2. Documentation Accuracy: The accuracy and accessibility of all process documentation, targeted at minimizing manual entry errors and ensuring data integrity at 0% error rates.
3. Standardization and Compliance: Measured by consistency in standardized procedures leading to reduced production variability and improved compliance scores.
4. Time-to-Market: Decrease in the duration from technology deployment to market-ready products, with an improvement goal of at least 25% in on-time delivery rates due to enhanced coordination.
KanBo's Role in Tracking Process Efficiency
KanBo is a powerful tool in advancing process efficiency through its robust capability to track Key Performance Indicators (KPIs). It enables pharmaceutical organizations to:
- Centralize Documentation: A singular hub for process documentation reduces errors and promotes seamless knowledge transfer.
- Automate Workflows: Standardized workflows remove inconsistencies, directly impacting the reliability and quality of drug manufacturing.
- Monitor Real-Time Changes: Dashboards and visualization tools allow stakeholders to trace process efficiency and proactively adjust to meet regulatory demands.
Data-Driven Decision-Making with KanBo Analytics
The game-changer lies in KanBo’s analytics, where real-time data insights are pivotal in strategizing and executing technology transfer projects. Here’s how:
- Immediate Feedback Loops: Stakeholders have access to up-to-the-minute updates on project statuses, facilitating quick and informed decision-making.
- Risk Predictive Analytics: Through predictive modeling, teams can preemptively identify and mitigate potential bottlenecks, refining the technology scale-up process.
- Enhanced Compliance: Real-time audit trails and documentation provide transparency and agility, slashing audit preparation times by half, thereby reinforcing strategic compliance planning.
KanBo's analytics uplift an organization's competitive edge by converting raw data into actionable strategies, transforming how pharmaceutical technology transfer projects are executed and managed. This agile approach allows companies to take command of their processes and focus on innovation, crafting a future where efficiency and compliance coexist harmoniously.
Glossary and terms
Glossary of KanBo Terms
Introduction
This glossary aims to provide clarity on the key terms and concepts associated with KanBo, a work management platform designed to facilitate the organization and execution of tasks. KanBo operates on a hierarchical structure of workspaces, spaces, and cards, offering an array of features to streamline user management, document handling, and reporting. Below are detailed explanations of essential terms within the KanBo ecosystem.
Core Concepts & Navigation
- KanBo Hierarchy: A structured system where workspaces encompass spaces, which contain cards, enabling organized task and project management.
- Spaces: The primary areas where users engage with tasks, consisting of collections of cards and equipped with features for customization and information display.
- Cards: Digital representations of tasks or individual items within a space, often used for task management.
- MySpace: A personalized space for users to curate and manage selected cards from various spaces, through the use of "mirror cards."
- Space Views: Different visualization formats for spaces such as Kanban, List, Table, Calendar, and Mind Map. Advanced views include Time Chart, Forecast Chart, and Workload view.
User Management
- KanBo Users: Managed through defined roles and permissions, allowing specific levels of access and interaction within spaces.
- User Activity Stream: A feature that records user interactions within spaces, providing an accessible activity history.
- Access Levels: Permission levels assigned to users, which may include roles like owner, member, and visitor, defining their interaction scope within spaces.
- Deactivated Users: Users who've been deactivated lose access but their previous activities remain visible within the platform.
- Mentions: A feature allowing users to be tagged in comments and messages, targeted via the "@" symbol for task notifications and discussions.
Workspace and Space Management
- Workspaces: Higher-level structures for organizing spaces, allowing further categorization and management.
- Workspace Types: Including private workspaces and standard spaces, offering different sharing and privacy configurations.
- Space Types: Classifications such as Standard, Private, and Shared, each with distinct access and invitation capabilities.
- Folders: Tools for organizing workspaces and managing their hierarchical structure.
- Space Details: Metadata related to a specific space, such as name, responsible person, budget, and timeframes.
- Space Templates: Templates used to create spaces with pre-configured settings, available to users with specific roles.
Card Management
- Card Structure: The foundational building blocks of work within KanBo, representing tasks and activities.
- Card Grouping: The ability to organize cards based on criteria, such as due dates, to enhance navigation and management.
- Mirror Cards: Feature that allows cards from different spaces to be viewed and managed in MySpace.
- Card Status Roles: Cards can only adopt a single status at any one time to signify current task progress.
- Card Relations: Enabling linking between cards to form parent-child or hierarchical relationships.
- Private Cards: Drafts of cards created in MySpace before being moved to the relevant working space.
Document Management
- Card Documents: Links to files stored in external libraries, shared across multiple cards, reflecting modifications universally.
- Space Documents: All documents within a space, housed in a designated default document library for that space.
- Document Sources: Allows multiple document sources per space, enabling collaboration across different spaces and involving templates from applications like Word and Excel.
Searching and Filtering
- KanBo Search: A search feature that accesses a wide range of content within the platform, scoped to various categories or a specific space.
- Filtering Cards: Functionality to narrow down card displays based on specific user-defined criteria.
Reporting & Visualization
- Activity Streams: Tracking and visualizing both user-specific and space-specific activities for comprehensive historical insight.
- Forecast Chart View: A visualization tool to predict future task progression by comparing completion scenario data.
- Time Chart View: Measures process efficiency based on the timeliness of card completions.
- Gantt Chart View: Displays time-dependent cards in a timeline format, aiding in complex project planning.
- Mind Map View: Organizes and visualizes card relationships in a graphical format to assist in brainstorming and structuring.
Key Considerations
- Permissions: User roles and permissions dictate accessibility and functionality within KanBo.
- Customization: Various customizable elements like custom fields and templates are available.
- Integration: KanBo's capability to integrate with external libraries, such as SharePoint, for document management.
This glossary provides a concise reference for understanding the fundamental concepts and features of KanBo, aimed at enhancing users' navigation and operation within the platform.
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Additional Resources
Work Coordination Platform
The KanBo Platform boosts efficiency and optimizes work management. Whether you need remote, onsite, or hybrid work capabilities, KanBo offers flexible installation options that give you control over your work environment.
Getting Started with KanBo
Explore KanBo Learn, your go-to destination for tutorials and educational guides, offering expert insights and step-by-step instructions to optimize.
DevOps Help
Explore Kanbo's DevOps guide to discover essential strategies for optimizing collaboration, automating processes, and improving team efficiency.
Work Coordination Platform
The KanBo Platform boosts efficiency and optimizes work management. Whether you need remote, onsite, or hybrid work capabilities, KanBo offers flexible installation options that give you control over your work environment.
Getting Started with KanBo
Explore KanBo Learn, your go-to destination for tutorials and educational guides, offering expert insights and step-by-step instructions to optimize.
DevOps Help
Explore Kanbo's DevOps guide to discover essential strategies for optimizing collaboration, automating processes, and improving team efficiency.