Infor CloudSuite Industrial review

Infor CloudSuite Industrial suits device makers that want compliance language spelled out by the vendor. Infor's medical device page says the ERP maintains electronic records and audit trails in line with FDA 21 CFR Part 11 and supports ISO 13485, GMP and global regulatory requirements, with validation-ready systems. Traceability covers serial genealogy and lot control, and the system generates device and batch history records across materials, production and quality events, so an auditor can see how each device or batch was built, tested and released. Nonconformances and CAPA run in controlled, auditable workflows. For stricter FDA needs Infor points to the Copley FDA Extended Solution, built on CloudSuite Industrial, which adds data auditability and electronic recording. The downsides: no published price, part of the FDA story depends on a partner extension, and the material is written for device makers, so pharma and biotech teams should compare it against QAD and SAP.

Who it is for

Medical device manufacturers that want Part 11 audit trails and DHRs in a cloud suite

Price

See vendor pricing (USD check pending).

US price check pending. See the vendor pricing page.

Key features

• Electronic records and audit trails in line with FDA 21 CFR Part 11
• Support for ISO 13485 and GMP requirements
• Device and batch history records (DHRs) for audits and recalls
• Serial genealogy and lot control across production, quality and orders
• Nonconformance and CAPA workflows

Strengths and weaknesses

• Strength: Infor names 21 CFR Part 11, ISO 13485 and GMP on its medical device page
• Strength: DHRs compile materials, production and quality events
• Strength: Copley FDA Extended Solution adds electronic recording for FDA compliance
• Weakness: No published USD price
• Weakness: Some FDA functions come from a partner extension rather than the core product
• Weakness: Page focuses on devices; pharma buyers get less detail

Key facts

• Regulations named: FDA 21 CFR Part 11, ISO 13485, GMP
• Traceability: Serial genealogy, lot control, DHRs
• Quality: Nonconformance and CAPA workflows
• FDA add-on: Copley FDA Extended Solution

Where it ranks

Infor CloudSuite Industrial is No. 6 in our Best ERP for Life Sciences verdict.