ARENA SOFTWARE VALIDATION

Simplify FDA Software
Compliance With Arena Validate

OUR CLOUD SOFTWARE IS DESIGNED FOR FAST VALIDATION

Arena Validate is designed to speed FDA 21 CFR Part 820 and Part 11 compliance. We help your teams spend less time validating Arena’s application with our complete validation package. Arena Validate includes the critical elements of change and document management, design controls, electronic records, electronic signatures, and quality management.

Take a Look

FOCUS ON YOUR CORE COMPETENCIES

We do most of the validation work, leaving you to determine your unique intended uses, and supplement those with our validation package. Arena Validate enables you to spend more time on your core competencies by helping your teams in the following ways:

Q.A. &
REGULATORY AFFAIRS

teams can leverage Arena’s proven validation methodology and expertise

VALIDATION
TEAMS

have fewer validation burdens and avoid system-level tests required for on-premises apps

EXECUTIVE STAKEHOLDERS

remain confident that everyone has the necessary documentation to validate Arena

PRODUCT
DEVELOPMENT

teams benefit by always having the latest Arena software release and enhancements

QUALITY
TEAMS

can receive quicker validation results to support compliance requirements

CROSS-FUNCTIONAL
TEAMS

can enjoy regular software enhancements with SaaS updates and easier validation

ELIMINATE FEAR OF UPGRADING

Validating software is difficult for traditional on-premises software solutions and often prevents customers from upgrading to the latest release. With Arena Validate, our validation experts do the heavy lifting for every Arena PLM and QMS release or enhancement. We help you:

SPEED DEVELOPMENT
AND EXECUTION

Receive a comprehensive set of validation documentation and reports for use as objective evidence
Leverage senior validation expert assistance with Arena application validation questions and concerns

MAKE THE IMPACT
ASSESSMENT EASIER

Gain early access to release notes to evaluate the scope of the upcoming release and assess the impact
Receive advanced Arena release notifications containing risk assessment and impact analysis

SIMPLIFY VALIDATION
FOR ENHANCEMENTS

Access validation documentation for new Arena releases
Receive over 1,600 user requirements and test cases, reducing the number you have to manage

AVOID DISRUPTIVE VALIDATION EFFORTS

We understand how disruptive change can be in your compliance environment. However, software applications must be upgraded to meet your expanding business requirements, new technology, and industry demands.

Arena Validate enables you to spend less time testing and documenting each release of Arena’s products so you have more time for designing and delivering safe, compliant devices to your customers.

READ WHITE PAPER

“Arena made the implementation very easy by giving us complete IQ and OQ documents. The wide range of standard out-of-the-box functionality narrowed the scope of our work even more. This resulted in a very productive and complete PQ while requiring much less management than other IT system implementations I have been a part of.”

Ed Reith Supply Chain Engineering Manager, Ebb Therapeutics