The system shall ensure Regulatory Compliance with: 49 CFR, TDG, IMDG, ADR, ADNR, RID, IATA, FDA 21 CFR Part 11, FDA 21 CFR Part 820, RoHS, WEEE, REACH, ISO 13485:2003 and applicable portions of ISO 14971.
Meets requirement. Aras Corp. has been used in highly regulated environments with both process and product compliance requirements. No software application can ensure regulatory compliance, but if used properly can support an organization achieving compliance. Aras Innovator has the functionality, traceability and controls required to support regulatory compliance in many industries.
The supplier shall provide the plan, technology, regulatory validation and resources for data migrations from all legacy systems to the future system.
Meets requirement. Aras Corp. internal resources can provide a full, turn-key PLM implementation including project planning, architecture, customization, data migration and end-user training. Aras Corp. will engage a partner (the CRO Group or Group of the company's choosing) to design and implement the regulatory validation.
The system shall provide pre-defined out-of-the-box change management workflows, that are CMII, ISO 13485, FDA 21 CFR Part 11 and 21 CFR Part 820 compliant and configurable to the company's processes.
Meets requirement. Aras Innovator is a certified CMPIC preferred vendor and a 4-Star CMII Certified solution. This indicates the highest level of adherence to the Institute of Configuration Managements' standards. The core workflow functionality includes functions such as electronic signatures that are required to support 21 CFR Part 11 and 21 CFR Part 820 compliance.
The standard out-of-the-box workflows can be easily modified using the included Aras Innovator Design Studio to automate the company's specific processes. With the Aras Innovator modeling engine, these customizations are both easy to implement and easy to support even through major system upgrades, including for heavily customized systems, in the annual Subscription fee. The company will have the confidence to adapt the software to fit requirements, without the risk of creating an expensive support problem down the road.