Turnkey ERP+QMS Validation
A turnkey ERP and QMS validation offering for medical device manufacturers, combining Cetec ERP software and validation-supporting documentation with QMS implementation, Computer Software Assurance, and ongoing validation services from Benten Creative.
Medical device manufacturers need more than ERP software with quality functionality. The system has to be configured for the business, validated for its intended use, and maintained as the software changes.
Cetec ERP and Benten Creative shorten that path by starting from an established baseline. Benten Creative maintains a pre-configured QMS inside Cetec ERP, developed around the quality processes medical device manufacturers need. When you select the turnkey offering, Cetec ERP clones that environment as the starting point for your implementation.
From there, Benten Creative works with your team to configure the QMS for your operation, validate Cetec ERP for its intended use, document the results, and maintain the validation package as Cetec ERP releases change.
The Cetec ERP Compliance Bundle provides the controlled software environment, testing evidence, release documentation, and other vendor-side inputs that support that validation process.
What the Turnkey Offering Includes
QMS Implementation
Benten Creative maintains a pre-configured QMS in Cetec ERP that serves as the baseline for turnkey implementations. Cetec ERP clones that environment for your company, giving you an established quality system to configure rather than a blank system to build from scratch.
The baseline includes core medical device quality processes such as:
- CAPA
- Nonconformance
- Quality alerts
- Equipment and calibration
- Document control
- Supplier quality
- Training and competency
- Supporting work instructions
- Administrator training
- Minor customer-specific configuration
From there, Benten Creative can configure the environment further based on your processes and selected implementation package.
Initial Validation
Benten Creative leads a risk-based Computer Software Assurance process based on the customer's intended use of Cetec ERP. Includes:
- Project kickoff and validation planning
- Customer-specific system and intended-use information
- Risk assessment
- Standard CSA protocols
- Test data
- Protocol execution in the customer's Cetec ERP environment
- Collection of objective evidence
- Documentation and resolution of minor test discrepancies
- Validation summary report
- Final customer validation package
Rather than handing your team a generic validation template, the process is tied to the way Cetec ERP will be configured and used in your business.
The Cetec ERP Compliance Bundle
The turnkey service builds on the Cetec ERP Compliance Bundle, an upgrade to the core Cetec ERP subscription that provides the software-side foundation for validation. It includes:
- Controlled hosting and release schedule
- Cetec ERP Quality Manual
- User Requirements Specification
- Test matrix and results
- Release and testing plans
- Validation summary documentation
- Detailed release documentation
- Sandbox environment for testing
The Compliance Bundle does not replace customer-specific validation. It gives Benten Creative and your internal quality team a controlled baseline and documented software evidence to work from.
Ongoing Validation Support
Validation continues after go-live. Cetec ERP releases four scheduled updates annually.
Benten Creative can assess each release against your intended use and determine what, if anything, needs to be tested before the update is incorporated into the validated system. Includes:
- Review of Cetec ERP release notes
- Identification of changes affecting intended use
- Validation and regulatory impact assessment
- Risk-based validation determination
- Regression testing when warranted
- Collection of objective evidence
- Release assessment or validation maintenance memo
- Updates to the validation package index and change history
Turnkey Validation Packages
Each package starts with Benten Creative’s pre-configured Cetec ERP QMS environment as the foundation. Choose the level of configuration and validation support your operation requires.
Basic Configuration
$5,000 / one-time upfront
Start from the standard Benten QMS baseline with supporting work instructions.
Standard Launch
$10,000 / one-time upfront
Add CSA execution, validation documentation, and administrator training.
Advanced Launch
$15,000 / one-time upfront
Standard Launch plus up to 20 hours of minor customer-specific configuration.
Advanced Implementation
Custom Quote (contact Benten Creative)
For customer-specific configurations, forms, reports, integrations, migration, or supplemental validation requirements.
Ongoing Validation Support
$500 / month
Supports up to four annual Cetec ERP releases.
Custom work, upgrades, integrations, audits, and on-site work may require separate scope.
One System. One Validation Path.
Cetec ERP and Benten Creative give medical device manufacturers one platform for ERP and QMS instead of separating quality from the manufacturing system it governs.
Benten Creative takes that platform through the customer-specific work required to validate it for intended use.
Together, the offering provides a defined path from software selection and QMS configuration through initial validation and ongoing maintenance, without asking your internal team to assemble the entire validation program from scratch.