Compliance Bundle for ERP Validation
The Cetec ERP Compliance Bundle provides the controlled software environment, documentation, testing records, and release controls needed to support ERP validation and ongoing maintenance.
Cetec ERP Compliance Bundle Can Help You
Validation requires more than testing your configuration once before go-live. Your validation partner needs documented software requirements, testing evidence, controlled releases, and a way to assess changes as the underlying ERP evolves. The Compliance Bundle gives your team and validation partner that foundation.Unite ERP + QMS in One System
- Manage ERP and quality processes in the same platform
- Keep production, quality, inventory, and financial records connected
- Reduce reliance on separate QMS software and disconnected records
- Carry traceability and quality data across the full manufacturing process
Unite ERP + QMS in One System
- Manage ERP and quality processes in the same platform
- Keep production, quality, inventory, and financial records connected
- Reduce reliance on separate QMS software and disconnected records
- Carry traceability and quality data across the full manufacturing process
What’s Included in the Compliance Bundle
Controlled Hosting & Release Schedule
Cetec ERP provides a controlled software environment with scheduled releases, giving regulated manufacturers a more stable baseline for validation and change assessment.
Cetec ERP Quality Manual
Documentation covering the quality practices Cetec ERP uses to manage software development, testing, and releases.
User Requirements Specification
A documented baseline of Cetec ERP software requirements that can be used as an input to customer validation activities.
Test Matrix & Results
Access documented test coverage and results that show how Cetec ERP requirements are tested.
Release & Testing Plans
Review the scope of Cetec ERP releases and the testing performed before software changes are deployed.
Summary Documentation
Receive summary documentation covering Cetec ERP software testing and the supporting evidence available for customer validation.
Detailed Release Documentation
Maintain a clear record of software changes so your validation team can assess whether a release affects intended use.
Sandbox Environment
Use a separate Cetec ERP sandbox environment for customer testing, release review, and validation activity before changes reach production.
Partner With Regulatory Experts
Benten has helped establish the compliance bundle, and can support all of your regulatory support requirements.
Why It Matters
Medical device manufacturers need more than ERP software with quality functionality. The system has to be validated for its intended use, and that validated state has to be maintained as the software changes.
One of the most time-consuming parts of that process is establishing what the software provider controls, what requirements exist, what has already been tested, and what changed between releases.
The Compliance Bundle gives your quality team and validation partner that software-side foundation. Cetec ERP provides a controlled release environment, documented software requirements, testing evidence, release documentation, and a separate sandbox for customer testing.
That does not replace customer-specific validation. Configuration, intended use, risk assessment, protocol execution, and final validation remain specific to your company. Benten Creative can provide that work separately, using the Compliance Bundle as the baseline for its validation process.
This distinction is reflected directly in the approved turnkey offering: Cetec ERP provides the supporting software environment, while Benten Creative configures the QMS, leads the Computer Software Assurance process, documents the results, and supports continued validation across Cetec ERP releases.
Pricing
$850/month