Kneat Gx Compliance by Design


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Kneat Gx Compliance by Design

  1. 1. Kneat GxCompliance by Design 1
  2. 2. What is Kneat Gx Kneat Gx creates and maintains sets of product, process or equipment lifecycle documents with less effort and higher quality Kneat can be applied to any process where compliance and data integrity is business critical and information is shared across a set of documents For example – Large project execution – Manufacturing facility validation documentation 2
  3. 3. Some Large Project Execution Concerns….. Right First Time translation of requirements Collaboration across multiple stakeholders Engineering data management – Data flow between different stakeholders – Data integrity – Management of change C&Q process – Test plans need to be appropriate and optimised – Test documents need to be aligned with latest design – Management of deviations and re-work process Timely handover of accurate and complete data / information to operations 3
  4. 4. Typical Project Execution Outcomes Corrupt, inaccurate, missing data Test documents not aligned with design C&Q process delayed and over budget As-building exercise is a headache Handover to operations is problematic Non-optimal start up impacts company goals 4
  5. 5. Kneat Gx Paperless Approach Document content is dynamically linked to a database which provides structure and context Automated assessment of the impact of change across all documents Streamlined execution of changes to documents Downstream life cycle documents/ test reports are auto-generated Online test execution and deviation processing Cloning of suites of documents for new projects maintaining embedded relationships Efficiency, Quality and Compliance built in 5
  6. 6. Kneat Modeling Concept 6
  7. 7. Kneat’s Powerful Leveraging of Work RE204 bioreactor cloned documents are at development closed status and are waiting for a document number to be assigned. These are new units created by simply cloning RE201 including all of its associated documentation, embedded relationships and model objects. 7
  8. 8. Document Change Execution Process Affected Documents Approved Auto Generate re- Re-test Document Auto Impact Documents B1.0 test Documents Assessment ChangeA1.0 Initiation C1.0A1.1 D1.0B1.1 Change Change Pre- Change Post- Approval Completed ApprovalC1.1 All docs Change automatically Execution and updated re-testD1.1 Approved Documents 8
  9. 9. Kneat Fit in Large Project Execution All lifecycle documents are generated, approved and executed within Kneat Global collaboration Automated and streamlined change execution Just in Time release of test documents Online testing and deviation management Auto-generation of test and acceptance reports 9
  10. 10. Kneat Fit in Large Project Execution Note: A/E can own the MPD for smaller projects • User/functional requirements Requirements • Risk assessment Management • Requirements traceability Process A/E Data • Design verification Master Project Import* Automation Kneat Document Database (MPD) Integrator Owned by Database Change Operations Data Execution Construction Mgr • Auto-impact assessment • Auto-retest scripts • Auto doc updating Equipment • FAT/SAT Vendor Receipt C&Q • IV/FV Data Verification Process • Online testing / Deviation Mgt Process • Acceptance Reports Construction Mgt Kneat Gx application (Owned by Operator)* Import on demand,periodically or at milestone 10
  11. 11. Kneat Benefits for Project Execution Engineering specifications and verification process can be standardised Global project execution through collaboration and live management oversight Design and test documents always aligned – On-line document change execution – Auto impact assessment – Auto updating of affected life cycle documents – Just in Time release of test protocols Right first time project deliverables translates to reduced Business Risk - Quality, Safety, Financial, and Operational 11
  12. 12. Kneat Opportunity for Operations Kneat can continue to provide value to operations in a new facility Instant access to original requirements, design basis and associated risk assessments Retention of project knowledge, practices and templates for future projects Ongoing document change execution related to facility modifications and additions Documentation relating to new equipment can be cloned from similar existing equipment 12
  13. 13. Kneat Supporting Ongoing Operations Enterprise Document Management System Approved documents published from Kneat Kneat DatabaseInitiation Closeout Facility Design Verify Modifications / Upgrades Construct Facility Lifecycle (20 – 30 years) Retirement Change execution based on robust impact assessment Lifecycle documentation is always audit ready and easily accessed 13
  14. 14. Kneat Fit in Site Infrastructure Management of all site documents Publishing of EDMS approved Kneat documents Kneat CAPA Generation/ Site Change Control Management of the System content of lifecycle* documents Doc status and change details* Lifecycle documents describe a regulated process, where info is shared acrossdocuments and compliance and data integrity are business critical. eg FacilityQualification 14
  15. 15. Kneat Benefits for Operations Ability to copy/clone work done on previous projects provides significant efficiencies Reduced time to market for new product launches Optimal plant performance is achieved sooner Lifecycle documents are audit-ready and maintained in a state of compliance at all times Lower risk of citations and warning letters Lower cost of compliance 15
  16. 16. Kneat Gx Infrastructure Web application based on Microsoft’s .NET platform Browser based access to secure optimized database Controlled login over Secure Sockets Layer (SSL) Full enterprise level scalability Fully validated to GAMP 5 ISPE guidelines and 21CFR Part 11 regulations System architecture facilitates integration with other IT applications 16
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