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.

1. (ATS6-PLAT08) AEP in a Validated
Environment
Mike Wilson
Advisory Product Manager
Platform Product Management
mike.wilson@accelrys.com

2. The information on the roadmap and future software development efforts are
intended to outline general product direction and should not be relied on in making
a purchasing decision.

3. Agenda
• Software validation challenges
• AEP tools available to help with validation
• Recommended AEP development practices

4. Overview
• Software Validation

5. Trends Driving Our Customers
Governmental Regulation
• Process Compliance Reporting
• Growing New Regulations
• Defect Tracking

6. Example Software Validation Process
Software Validation
Validation is defined as documented evidence that the system…
– Is installed per system requirements (IQ)
– Operates and performs per business functional
requirements and system requirements (OQ)
– Performs per business requirements (PQ)

7. • AEP can be viewed as a commercial-off-the-shelf application:
– Development and maintenance is performed under Accelrys’ Quality
Management System (QMS)
– Customers can perform a vendor audit (remote or on-site) of the QMS as
part of their validation process
• Customers will author a validation plan for AEP
– A methodology to control data and interfaces into and out of a protocol
may also be required
Validation Strategy for AEP
AEP can be validated today

8. Validation Services
• Working with the customer’s
business, validation, and
quality groups to author
validation deliverables such as:
– Validation Plan
– Client User Requirements
– Configuration Specifications
– Change Management
Procedures
– Test Plan
– Training Plan
– User Acceptance Test Scripts
Validation Collateral
• AEP Functional Requirements
• Functional Verification
(executed test scripts against
the functional requirements)
• Requirements Traceability
Matrix (Excel)
Validation Services Offered by Accelrys

9. Questions
• How many have validated AEP within their company?
• What were the major challenges?

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 functionality
changes
• Export/Import Configuration
– Transfer complete server configurations to other servers

11. Protocol Development Practices for Validation
Development Test Production
Build
• Build components &
protocols in Pipeline
Pilot on AEP server
• Write regression
protocols to test
Test
• Final verification
confirming correct
publishing per Test
• Run regression suite
Publish
• Upon completion of
Test approvals,
publish Package to
Production
Test
• Validation and User
Acceptance testing
• Run regression suite
Test
• Initial testing
• Create Package on
AEP server
Publish
• Publish Package to
Test
• Iterate changes
through Development

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 limit
potential for change to validated protocols and components

13. Package Benefits
• Packages can be useful to show consistent, controlled
deployment 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 tests
are included, packages
form a complete, self-
verifiable unit of
functionality

14. Packaging Resources
• “Application Packaging Guide”
– Part of Integration collection
– Pipeline Pilot Help Center in the
Developer category
• ATS6-DEV06 session recording
– “Using Packages for
Enterprise Application
Delivery”
– Practical, how-to session

15. Regression Test Protocols
A regression framework is an essential tool in maintaining a component
collection 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. Regression Protocols
Regression protocols are standard protocols that write one or
more data files as the job results
• At the end of the job, each output file is compared against a
baseline file and any differences are reported
• Use non-binary writer components to write out the data that
you want to compare
• The regression utility automatically compares the outputs to
the baseline files of the same name

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 automatic
execution
– 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 test
plan to prove published components and protocols are
operating as designed and tested

18. Regress.exe Resources
• “Component Development
Regression Test Guide”
– Pipeline Pilot Help Center in
the Developer category
• Accelrys Community forum

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 protocol
packages
– Most likely from Test to Production
– Or, copy Production to Development to reset that environment for new
development

20. Export/Import Usage Notes
• Currently supported when importing on the same
operating system
– Windows -> Windows, Linux -> Linux
• Importing a configuration removes all existing settings on
the target server and replaces them with the settings in
the imported file
– Current configuration is automatically backed up before import

21. Protocol Development Practices for Validation
Development Test Production
Build
• Build components &
protocols in Pipeline
Pilot on AEP server
• Write regression
protocols to test
Test
• Final verification
confirming correct
publishing per Test
• Run regression suite
Publish
• Upon completion of
Test approvals,
publish Package to
Production
Test
• Validation and User
Acceptance testing
• Run regression suite
Test
• Initial testing
• Create Package on
AEP server
Publish
• Publish Package to
Test
• Iterate changes
through Development
Workflow also applicable to complete servers using export/import

22. Summary
• AEP can be – and has
been – validated
– Standalone
– As part of compliance
support applications like
ELN, LES, EBR, etc.
– Accelrys has passed
customer audits – our
controls and development
lifecycle are proven
• AEP includes features to
help with validation efforts
– Packages
– Regression Tests
– Export/Import Configuration
• Additional Resources
– Accelrys Community
– Accelrys Developer
Documentation (Help Center
Developer Mode)