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Oracle Quarterly Patches and FDA Validation

In today’s fast moving SaaS environment, organizations are provided quarterly feature releases and the opportunity to continually innovate and enable new digital capabilities. 

Many companies, however, struggle to keep up with quarterly testing cycles and are missing the opportunity to achieve new, high-impact business outcomes through their Oracle investments.

To truly harness the value of Oracle, companies need a provider that can transcend traditional support services and guide them in their ongoing strategic journey. GoSaaS’ proven tools and methods operationalize & automate quarterly release planning and execution activities while preparing you for what’s ahead – Allowing you to focus on enablement of new digital capabilities and innovation.

Are you facing these challenges?

Difficulty with resource/ramping productivity during release cycles

Uncertainty and challenges arise from the extensive release documentation, leaving questions about its applicability

Irregular adoption of new features that maybe holding you back

The effort put into supporting unnecessary extensions or applications

Absence of a strategic plan that takes into account upcoming releases.

GoSaaS has provided software application validations to several manufacturing Companies across industry verticals.
Validations include:

  • Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)

  • Validation scripts that have been developed and delivered based on FDA andvindustry standards

  • Scripts are provided for each module of Oracle Product Lifecycle Management (PLM) Cloud, GoSaaS Environmental Governance & Compliance (EG&C) and GoSaaS Employee Training System (ETS)

  • ​GoSaaS has provided resources/people for running the scripts and support when customers prefer to run the scripts themselves

  • GoSaaS has options for automatically performing ongoing validations or providing updated scripts in the case of software application updates and upgrades. For example: Oracle Product Lifecycle Management (PLM) Cloud receives quarterly updates for which customers may or may not opt in. GoSaaS performs the validations as required by the FDA and other regulatory bodies and reports the results automatically.

Value add services

  • Tailored release notes

  • Functionality gap assessment

  • Customization rationalization

  • Innovation workshopping

  • Flexible commercial terms for support contracts

Validation Pack Creation Workflow

GoSaaS Validation scripts are developed and delivered based on FDA and industry standards. We provide staff augmentation for running the scripts and support when customers prefer to run them themselves.

Our process workflow is as follows:


  • PLM/Product Design finalized 

  • Validation Plan Created 

  • SRS Creation

  • Assess risks

  • Create URS/FRS/TM

  • Provide OQ

  • Create test cases for IQ

  • Create test cases for PQ

  • Provide/Execute Documents

Can currently offer automated testing for the PLM Performance Qualification and ETS Operational Qualification.

fda process validation guidance

Let us keep your organization in great shape while you focus on your business.

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