(ATS6-APP08) ADQM SolutionDeploymentBill BuoteCTO ADQMADQM Business UnitBill.Buote@accelrys.com
The information on the roadmap and future software development efforts areintended to outline general product direction an...
ADQM Deployment• Objective is to provide a fast time to benefit for you– IT installation– IQ/OQ/PQ– Content development: m...
ADQM DeploymentRapid Deployment of ADQM Applications• Environmental Monitoring (Microbiological)• Immediate Release Solid ...
Open Virtualization Format PackageTraditional IT installation with BestPractice ContentORPre-Configured VirtualMachine App...
Import the Appliance
ADQM Application Packs• EnvironmentalMonitoringIncorporating:• Accelrys LIMS (EM)
Preconfigured Application
DemoConfiguring Standard Content• Edit an entity• Run Qualification Report
Sample Type
Qualification Report
What is a Sample Type?• Sample Types describe the workflow, datacapture and chain of custody for individualEM samples.• Th...
What is a Location/Location Type?• Location Types define both the information that is recorded and specific to thattype of...
DemoConfiguring Standard Content• Update a workflow• Run Qualification Report
Workflow
What is a Sampling Plan?• A Sampling Plan defines both the frequency ofsampling and the locations to be sampled.• Planned ...
Dissolution Example ContentDissolutionParametersProcessProduct/MaterialTrainingSupporting ContentMethodProcedureMethodProc...
ADQM Application Packs• Immediate Release• Solid Dosage• Single APIIncorporating:• Accelrys LIMS (SSM & IM)• Accelrys LES
Customers201 - Routine SM WorkflowSample isreceived in theLabSample isbooked intoSMProductSpecification isassignedLES Test...
1 - Routine SM Workflow DetailSample isreceived in theLabA Sample is received against a Work Request and createdas a recor...
1 - Routine SM Workflow DetaileMethods requested by SM are executed in the LES by theAnalyst. This is detailed in Story 2....
Customers232 – eMethod ExecutioneMethod isopened in LESfor executioneMethodParameters arecollectedInventory Datais collect...
2 – eMethod Execution DetailAn eMethod, executed in the Accelrys LES, is a genericand reusable analytical method skeleton ...
2 – eMethod Execution DetailData can be gathered electronically from most RS232 capableinstruments, e.g balances and pH me...
Story 2 – What is an eMethod?Parameter Name Parameter ValueProduct PseudozoneSample Weight 1.0000gSample Volume 100mLSampl...
2 – What is an eMethod?• An eMethod is an analytical technique focused generic and reusable method.• Product specific para...
2 – What eMethods are included?Potency (& impurities) ThicknessDissolution FriabilityContent Uniformity Water ContentCU by...
Customers29Story 3 – Creating a Product SpecificationTest Templatesare created inLIMSProductSpecification iscreatedTests a...
3 – Creating a Product SpecificationA template Test is created in LIMS. This may be definedonce and used in many Product S...
• Standard Best Practice Content is the key to rapid deployment• Access to this content can be provided in a number of way...
32Thank you.Accelrys, Inc.9 Industrial RoadMilford, MA 01757
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(ATS6-APP08) ADQM Solution Deployment

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This session will demonstrate a new approach to LIMS implementations eliminates the complexities, excessive customization and lengthy associated validation requirements inherent with legacy LIMS—offering fast, “out-of-the-box” deployment capabilities, no custom coding, easy integration into existing software platforms and enterprise-wide data management capabilities.
Each Accelrys LIMS application comes with Workflow Editors that eliminate traditional software custom-coding processes, enabling your own internal system administrator to deploy needed applications, workflows and procedures using a simple drag-and-drop process and dialog interface.
When finished with the workflow editing, a single mouse click generates a complete validation document for the application, workflow or procedure created. Built-in compliance at the “core technology” level turns qualification/validation into a simple, fast document review with no need for external validation consultants, even in regulated environments.

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(ATS6-APP08) ADQM Solution Deployment

  1. 1. (ATS6-APP08) ADQM SolutionDeploymentBill BuoteCTO ADQMADQM Business UnitBill.Buote@accelrys.com
  2. 2. The information on the roadmap and future software development efforts areintended to outline general product direction and should not be relied on in makinga purchasing decision.
  3. 3. ADQM Deployment• Objective is to provide a fast time to benefit for you– IT installation– IQ/OQ/PQ– Content development: methods / process– Qualification and Validation• Long term objective is “Cloud” deployment– Both public and private cloud• Standard best practice content is being made availablenow based on 15 years of deployment experience
  4. 4. ADQM DeploymentRapid Deployment of ADQM Applications• Environmental Monitoring (Microbiological)• Immediate Release Solid Dosage FormsStandard Content• Preconfigured Entities• Automatic Qualification Documents
  5. 5. Open Virtualization Format PackageTraditional IT installation with BestPractice ContentORPre-Configured VirtualMachine Appliance
  6. 6. Import the Appliance
  7. 7. ADQM Application Packs• EnvironmentalMonitoringIncorporating:• Accelrys LIMS (EM)
  8. 8. Preconfigured Application
  9. 9. DemoConfiguring Standard Content• Edit an entity• Run Qualification Report
  10. 10. Sample Type
  11. 11. Qualification Report
  12. 12. What is a Sample Type?• Sample Types describe the workflow, datacapture and chain of custody for individualEM samples.• The package contain N pre-configuredSample Types:• Contact Plates• Settle Plates• Non-viable Air
  13. 13. What is a Location/Location Type?• Location Types define both the information that is recorded and specific to thattype of location and the Sample Type to be collected.• Individual Sampling Locations are then assigned the Location Type and theproperty values are entered.Property ValueLocation Type Floor Settle PlateLocation Name 001 Vessel 1Room Micro ProductsAlert Limit 1 CFUAction Limit 5 CFUProperty ValueLocation Type Viable AirLocation Name 002 Hood 1Room Aseptic FillAlert Limit 0 CFUAction Limit 1 CFU
  14. 14. DemoConfiguring Standard Content• Update a workflow• Run Qualification Report
  15. 15. Workflow
  16. 16. What is a Sampling Plan?• A Sampling Plan defines both the frequency ofsampling and the locations to be sampled.• Planned sampling dates are the represented inan interactive calendar view that facilitates rapidworkflow processing.
  17. 17. Dissolution Example ContentDissolutionParametersProcessProduct/MaterialTrainingSupporting ContentMethodProcedureMethodProcedures ReportsReportsInstrumentsInstrumentsProtocolsProtocolsTypes andTemplatesReferencedModules
  18. 18. ADQM Application Packs• Immediate Release• Solid Dosage• Single APIIncorporating:• Accelrys LIMS (SSM & IM)• Accelrys LES
  19. 19. Customers201 - Routine SM WorkflowSample isreceived in theLabSample isbooked intoSMProductSpecification isassignedLES Tests arerequested andassignedTests areexecuted in LESResults areposted back tothe SampleSample Testsare approvedSampleDisposition ismade
  20. 20. 1 - Routine SM Workflow DetailSample isreceived in theLabA Sample is received against a Work Request and createdas a record in the SM Module of Accelrys LIMS. Pertinentsample information is collected as part of the record; Lot,Market, Product, etc.Sample isbooked intoSMProductSpecification isassignedA Product Specification is a managed entity within SM whichcontains all of the Test and Component records required bythe Sample. A component is a combination of result entryfield and an optional specification limit.LES Tests arerequested andassignedProcedure Sessions are created in the LES directly from SMand can be assigned to an Analyst or Group.
  21. 21. 1 - Routine SM Workflow DetaileMethods requested by SM are executed in the LES by theAnalyst. This is detailed in Story 2.Test results are automatically posted back to the TestComponents belonging to the Product Specification assignedto the Sample. Any limits are checked, in real-time, as theresults are posted.Sample and Test approvals are made in SM. A sampledisposition is made. The Work Request may then becompleted, or remain open for further related samples tobe appended.Tests areexecuted in LESResults areposted back tothe SampleSample Testsare approvedSampleDisposition ismade
  22. 22. Customers232 – eMethod ExecutioneMethod isopened in LESfor executioneMethodParameters arecollectedInventory Datais collectedfrom IMTest Data ismanuallyrecordedTest Data iscollected fromInstrumentsTest Data iscollected fromReportsFinal Resultsare determinedeMethodexecution isreviewed
  23. 23. 2 – eMethod Execution DetailAn eMethod, executed in the Accelrys LES, is a genericand reusable analytical method skeleton which can beused many times by externalizing product specificparameters and gathering them at execution time. Seefollowing slide for more detail.Consumables and Inventory, e.g. reagents, are tracked in theeMethod using the Accelrys LIMS IM Module.As required by the eMethod data may be entered manuallythrough context specific data entry fields. E.g. calendarcontrols, drop downs and format specific fields.eMethod isopened in LESfor executioneMethodParameters arecollectedInventory Datais collectedfrom IMTest Data ismanuallyrecorded
  24. 24. 2 – eMethod Execution DetailData can be gathered electronically from most RS232 capableinstruments, e.g balances and pH meters.The eMethod will also verify the suitability of use for thespecific instrument via the LIMS Metrology Module.Data can be gathered electronically directly from PCgenerated reports, e.g. PDF, CSV, XLS. Also, direct to databasecommunication is standard for Empower CDSResults may be calculated and limits applied in real time,flagging potential issues to both Analyst and Manager. TheeMethod is then reviewed and the record completed readyfor posting back to SM.Test Data iscollected fromInstrumentsTest Data iscollected fromReportsFinal Resultsare determinedeMethodexecution isreviewed
  25. 25. Story 2 – What is an eMethod?Parameter Name Parameter ValueProduct PseudozoneSample Weight 1.0000gSample Volume 100mLSample Diluent MethanolDetection Wavelength 254nmPath Length 1cmParameter Name Parameter ValueProduct CureallSample Weight 0.500Sample Volume 200Sample Diluent WaterDetection Wavelength 214Path Length 1Parameter Name Parameter ValueProduct CureallSample Weight 0.500Sample Volume 200Sample Diluent WaterDetection Wavelength 214Path Length 1Parameter Name Parameter ValueProduct CureallSample Weight 0.500Sample Volume 200Sample Diluent WaterDetection Wavelength 214Path Length 1Parameter Name Parameter ValueProduct CureallSample Weight 0.500Sample Volume 200Sample Diluent WaterDetection Wavelength 214Path Length 1Sample Weight [g] 0.9998Methanol ID 1423209UV Equipment ID UV01Absorbance [AU] 0.613Potency [%w/w] 98.7Potency eMethod [UV]Sample PreparationWeigh 1.0000g of Pseudozone into a100mL volumetric flask. Dilute tovolume with Methanol.MeasurementsMeasure the absorbance of thesolution at 254nm using a 1cm pathlength (cuvette).ManyinterchangeableeMethod parametersets
  26. 26. 2 – What is an eMethod?• An eMethod is an analytical technique focused generic and reusable method.• Product specific parameters such as API name or sample preparation requirementsare merged with the eMethod at time of execution.• eMethod parameter sets are defined and managed within Accelrys LIMS.• An eMethod is not intended to be used in the absence of the official controlledanalytical method.• During execution procedural clarity is provided as a combination of the embeddedgeneric procedure text and data collection instructions, the context provided bydata collection field names and through the display of product specific parametersare key points of the eMethod workflow.
  27. 27. 2 – What eMethods are included?Potency (& impurities) ThicknessDissolution FriabilityContent Uniformity Water ContentCU by Weight Variation IdentificationAverage WeightAppearance Generic Solutions PrepHardness Generic Standards Prep
  28. 28. Customers29Story 3 – Creating a Product SpecificationTest Templatesare created inLIMSProductSpecification iscreatedTests areappended toSpec. fromTemplatesTests areassignedspecificationLimitsSpec is routedthroughApprovalsprocessEffective date isassigned toSpec.Spec becomes‘live’ onEffective dateSpec isavailable to beassigned tosamples
  29. 29. 3 – Creating a Product SpecificationA template Test is created in LIMS. This may be definedonce and used in many Product Specifications.A Product Specification is created in LIMS andTests assigned from templates. It is at this stagethat specification limits are assigned.Once defined the Product Specification is routed through anelectronic Qualification process defined by an internalworkflow.Test Templatesare created inLIMSProductSpecification iscreatedTests areassignedspecificationLimitsSpec is routedthroughApprovalsprocessEffective date isassigned toSpec.Spec becomes‘live’ onEffective dateSpec isavailable to beassigned tosamplesOnce approved an effective date is assigned to the ProductSpecification. Once this date has been reached theSpecification becomes ‘Active’ and assignable to futureincoming samples.
  30. 30. • Standard Best Practice Content is the key to rapid deployment• Access to this content can be provided in a number of ways– Traditional Server Installation– VM Appliance– Cloud• http://accelrys.com/products/process-management-and-complianceSummary
  31. 31. 32Thank you.Accelrys, Inc.9 Industrial RoadMilford, MA 01757

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