Regulatory Compliance — Chemical Pharma ERP
Build GMP, FDA 21 CFR Part 11 and WHO-GMP compliance into daily operations, not into audit-week panic.
Request a Demo →Compliance as a way of working
For a regulated manufacturer, compliance is not a document — it is how every batch, record and change is controlled, every day. GMP, 21 CFR Part 11, WHO-GMP and market-specific rules demand audit trails, access control, validated records and change management that hold up under inspection.
This module builds those controls into the system: electronic records and signatures, audit trails, access control, and change and deviation management — so an inspection is answered from live records, not a frantic pre-audit clean-up.
It connects directly to the rest of your Chemical Pharma ERP, and can be extended with AI or mobile apps for field teams.
What the module handles
The controls regulators expect
How it works
From controlled record to a passed inspection.
What it changes for your business
Other modules in the Chemical Pharma ERP
One integrated system
Who it is for
Manufacturers under regulatory oversight:
Regulatory Compliance — frequently asked questions
Which regulations does it support?
It is built to support GMP, FDA 21 CFR Part 11 and WHO-GMP expectations, with the electronic records, signatures, audit trails and controls that these frameworks require.
How does it protect data integrity?
Immutable audit trails, role-based access and controlled electronic records support ALCOA data-integrity principles, so records are attributable, legible, contemporaneous, original and accurate.
Does it manage change and deviations?
Yes. Changes, deviations and CAPA are handled formally with routing and approval, so nothing is altered in an uncontrolled way.
Will it help during inspections?
It will. Because controlled records and audit trails are maintained live, inspections are answered directly from the system instead of through a last-minute clean-up.
See Regulatory Compliance in your Chemical Pharma ERP
See Regulatory Compliance make you inspection-ready every day — book a demo aligned to your market approvals.
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