(ATS6-PLAT08) AEP in a ValidatedEnvironmentMike WilsonAdvisory Product ManagerPlatform Product Managementmike.wilson@accel...
The information on the roadmap and future software development efforts areintended to outline general product direction an...
Agenda• Software validation challenges• AEP tools available to help with validation• Recommended AEP development practices
Overview• Software Validation
Trends Driving Our CustomersGovernmental Regulation• Process Compliance Reporting• Growing New Regulations• Defect Tracking
Example Software Validation ProcessSoftware ValidationValidation is defined as documented evidence that the system…– Is in...
• AEP can be viewed as a commercial-off-the-shelf application:– Development and maintenance is performed under Accelrys’ Q...
Validation Services• Working with the customer’sbusiness, validation, andquality groups to authorvalidation deliverables s...
Questions• How many have validated AEP within their company?• What were the major challenges?
AEP 9 Features Supporting Validation Efforts• Packages– Read-only groups of protocols and components• Regression Tests– Pr...
Protocol Development Practices for ValidationDevelopment Test ProductionBuild• Build components &protocols in PipelinePilo...
Package Overview• Packages are groups of protocols and components– Organized per your requirements• Packages make distribu...
Package Benefits• Packages can be useful to show consistent, controlleddeployment of functionality for validation• Package...
Packaging Resources• “Application Packaging Guide”– Part of Integration collection– Pipeline Pilot Help Center in theDevel...
Regression Test ProtocolsA regression framework is an essential tool in maintaining a componentcollection for Accelrys Ent...
Regression ProtocolsRegression protocols are standard protocols that write one ormore data files as the job results• At th...
Facilitating Validation Test Efforts• Regression protocols and baselines can be part of a package– Inheriting the read-onl...
Regress.exe Resources• “Component DevelopmentRegression Test Guide”– Pipeline Pilot Help Center inthe Developer category• ...
Export/Import Configuration• Export the server’s configuration for use in another server– New in AEP 9– Different from XML...
Export/Import Usage Notes• Currently supported when importing on the sameoperating system– Windows -> Windows, Linux -> Li...
Protocol Development Practices for ValidationDevelopment Test ProductionBuild• Build components &protocols in PipelinePilo...
Summary• AEP can be – and hasbeen – validated– Standalone– As part of compliancesupport applications likeELN, LES, EBR, et...
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(ATS6-PLAT08) AEP in a Validated Environment

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Validation requires well documented plans, practices, and records to prove a system is operating correctly. Attend this session to learn more about how Accelrys Enterprise Platform can be effectively deployed in validated environments and tooling that is available to assist in validating AEP deployments.

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(ATS6-PLAT08) AEP in a Validated Environment

  1. 1. (ATS6-PLAT08) AEP in a ValidatedEnvironmentMike WilsonAdvisory Product ManagerPlatform Product Managementmike.wilson@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. Agenda• Software validation challenges• AEP tools available to help with validation• Recommended AEP development practices
  4. 4. Overview• Software Validation
  5. 5. Trends Driving Our CustomersGovernmental Regulation• Process Compliance Reporting• Growing New Regulations• Defect Tracking
  6. 6. Example Software Validation ProcessSoftware ValidationValidation is defined as documented evidence that the system…– Is installed per system requirements (IQ)– Operates and performs per business functionalrequirements and system requirements (OQ)– Performs per business requirements (PQ)
  7. 7. • AEP can be viewed as a commercial-off-the-shelf application:– Development and maintenance is performed under Accelrys’ QualityManagement System (QMS)– Customers can perform a vendor audit (remote or on-site) of the QMS aspart of their validation process• Customers will author a validation plan for AEP– A methodology to control data and interfaces into and out of a protocolmay also be requiredValidation Strategy for AEPAEP can be validated today
  8. 8. Validation Services• Working with the customer’sbusiness, validation, andquality groups to authorvalidation deliverables such as:– Validation Plan– Client User Requirements– Configuration Specifications– Change ManagementProcedures– Test Plan– Training Plan– User Acceptance Test ScriptsValidation Collateral• AEP Functional Requirements• Functional Verification(executed test scripts againstthe functional requirements)• Requirements TraceabilityMatrix (Excel)Validation Services Offered by Accelrys
  9. 9. Questions• How many have validated AEP within their company?• What were the major challenges?
  10. 10. AEP 9 Features Supporting Validation Efforts• Packages– Read-only groups of protocols and components• Regression Tests– Protocols that can be used to detect baseline functionalitychanges• Export/Import Configuration– Transfer complete server configurations to other servers
  11. 11. Protocol Development Practices for ValidationDevelopment Test ProductionBuild• Build components &protocols in PipelinePilot on AEP server• Write regressionprotocols to testTest• Final verificationconfirming correctpublishing per Test• Run regression suitePublish• Upon completion ofTest approvals,publish Package toProductionTest• Validation and UserAcceptance testing• Run regression suiteTest• Initial testing• Create Package onAEP serverPublish• Publish Package toTest• Iterate changesthrough Development
  12. 12. Package Overview• Packages are groups of protocols and components– Organized per your requirements• Packages make distribution easier– Supports a release process functionality changes• Package content can NOT be edited– AEP enforces the read-only nature of package contents• Recommendation: use packages wherever possible to limitpotential for change to validated protocols and components
  13. 13. Package Benefits• Packages can be useful to show consistent, controlleddeployment of functionality for validation• Packages can be used for change control– Build in Development instance– Package and deploy to Test– Deploy to Production• When regression testsare included, packagesform a complete, self-verifiable unit offunctionality
  14. 14. Packaging Resources• “Application Packaging Guide”– Part of Integration collection– Pipeline Pilot Help Center in theDeveloper category• ATS6-DEV06 session recording– “Using Packages forEnterprise ApplicationDelivery”– Practical, how-to session
  15. 15. Regression Test ProtocolsA regression framework is an essential tool in maintaining a componentcollection for Accelrys Enterprise Platform (AEP)• Write and maintain a set of regression protocols– Test for backward compatibility– Test for functional regression between releases of your collections and protocols– Incorporate in your validation test plan• AEP includes a regression testing tool– Deployed with all server installations– Reports protocol failures– Reports results that differ from stored baselines
  16. 16. Regression ProtocolsRegression protocols are standard protocols that write one ormore data files as the job results• At the end of the job, each output file is compared against abaseline file and any differences are reported• Use non-binary writer components to write out the data thatyou want to compare• The regression utility automatically compares the outputs tothe baseline files of the same name
  17. 17. Facilitating Validation Test Efforts• Regression protocols and baselines can be part of a package– Inheriting the read-only attributes of packaged protocols• Regression test runs can be scheduled for automaticexecution– For continuous integration during protocol development– To support OQ/PQ in test and production environments• Create sets of regression tests as part of validation test plan• Consider using regression tests as part of a validation testplan to prove published components and protocols areoperating as designed and tested
  18. 18. Regress.exe Resources• “Component DevelopmentRegression Test Guide”– Pipeline Pilot Help Center inthe Developer category• Accelrys Community forum
  19. 19. Export/Import Configuration• Export the server’s configuration for use in another server– New in AEP 9– Different from XMLDB backup/restore• Promote an entire server configuration– Users, Groups, Permissions– Server Settings, Security Assignments• Could be used in a promotion workflow similar to that of protocolpackages– Most likely from Test to Production– Or, copy Production to Development to reset that environment for newdevelopment
  20. 20. Export/Import Usage Notes• Currently supported when importing on the sameoperating system– Windows -> Windows, Linux -> Linux• Importing a configuration removes all existing settings onthe target server and replaces them with the settings inthe imported file– Current configuration is automatically backed up before import
  21. 21. Protocol Development Practices for ValidationDevelopment Test ProductionBuild• Build components &protocols in PipelinePilot on AEP server• Write regressionprotocols to testTest• Final verificationconfirming correctpublishing per Test• Run regression suitePublish• Upon completion ofTest approvals,publish Package toProductionTest• Validation and UserAcceptance testing• Run regression suiteTest• Initial testing• Create Package onAEP serverPublish• Publish Package toTest• Iterate changesthrough DevelopmentWorkflow also applicable to complete servers using export/import
  22. 22. Summary• AEP can be – and hasbeen – validated– Standalone– As part of compliancesupport applications likeELN, LES, EBR, etc.– Accelrys has passedcustomer audits – ourcontrols and developmentlifecycle are proven• AEP includes features tohelp with validation efforts– Packages– Regression Tests– Export/Import Configuration• Additional Resources– Accelrys Community– Accelrys DeveloperDocumentation (Help CenterDeveloper Mode)

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