Kneat Gx Compliance by Design
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Kneat Gx Compliance by Design

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Kneat Gx Compliance by Design Kneat Gx Compliance by Design Presentation Transcript

  • Kneat GxCompliance by Design 1
  • 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
  • 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
  • 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
  • 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
  • Kneat Modeling Concept 6
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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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