Meet FDA 21 CFR Part 111 requirements with comprehensive batch records, complete lot traceability, CoA management, and potency tracking—all designed specifically for dietary supplement and nutraceutical manufacturers.

The dietary supplement industry faces intense FDA scrutiny. Managing cGMP compliance, documentation, and traceability with inadequate tools puts your business at risk.
Meeting 21 CFR Part 111 requirements for batch production records, master manufacturing records, and component documentation is complex and high-stakes.
Paper-based or spreadsheet batch records miss critical details, lack proper sign-offs, and create compliance gaps that auditors will find.
When an ingredient supplier has a potency or contamination issue, tracing affected finished products lot-by-lot takes days instead of minutes.
Managing certificates of analysis, identity testing results, and component specifications across dozens of ingredients without a system is error-prone.
Without proper systems, products ship with expired or out-of-spec ingredients. Stability testing data lives in disconnected files.
Disconnected systems mean you cannot see true inventory levels, production status, or what can actually be manufactured today.
Built specifically for dietary supplement manufacturers, Fiddle provides the cGMP documentation, traceability, and production tools required by FDA regulations.
Create master manufacturing records and batch production records that meet 21 CFR Part 111 requirements. Include all required documentation automatically.
Learn more →Track every dietary ingredient and component from receipt through finished product distribution. Run forward and backward traces in seconds.
Learn more →Attach certificates of analysis, identity test results, and specifications to component lots. Ensure only verified materials release for production.
Track component and finished product expiration dates. Manage retest dates and stability data. Enforce FIFO and prevent expired material use.
Build product formulas with exact potencies and overages. Track label claims against actual formulation to ensure product meets specifications.
Learn more →Visual work order management with automatic component allocation. See exactly what you can produce based on available, released inventory.
Learn more →Everything you need to maintain cGMP compliance, manage production, and grow your supplement business.
Create master manufacturing records (MMRs) and batch production records (BPRs) that satisfy FDA cGMP requirements. Document component identity verification, in-process testing, equipment calibration, and operator sign-offs—all with complete audit trails.

Achieve complete forward and backward traceability from raw dietary ingredients through finished product distribution. Meet FDA requirements for one-step-up, one-step-back traceability and respond to recalls within hours, not days.

Manage the entire component qualification process from receipt through release. Attach certificates of analysis, identity testing results, and specifications to each lot. Prevent unreleased components from entering production.

Discover how Fiddle's purpose-built features help supplements & nutraceuticals manufacturers streamline operations, maintain compliance, and grow their business.
Create cGMP-compliant master manufacturing records and batch production records.
Learn More →Track dietary ingredients from receipt through distribution for FDA compliance.
Learn More →Build product formulas with exact potencies and manage label claim compliance.
Learn More →Explore how Fiddle's specialized solutions help supplements & nutraceuticals businesses solve their unique challenges and achieve operational excellence.
Built-in compliance controls for 21 CFR Part 111 cGMP requirements and FDA regulations.
View Compliance Features →Create master manufacturing records and batch production records with digital signatures and audit trails.
Explore Batch Records →Track dietary ingredients from receipt through distribution for complete FDA compliance.
Learn about Lot Traceability →Build product formulas with exact potencies and manage label claim compliance.
Explore BOM Management →Automated expiration date management with FIFO enforcement for ingredient freshness.
See Expiration Tracking →Visual production planning with automatic component allocation and release status tracking.
Discover Production Scheduling →See why leading supplement brands choose Fiddle for their cGMP compliance, inventory, and production needs.
When FDA came for our inspection, they spent an hour going through our batch records and traceability documentation. The inspector commented that our records were some of the most complete she had seen from a company our size. That is Fiddle.
We used to spend 20+ hours per week managing spreadsheets, CoAs, and batch documentation. Fiddle automated most of that. Now we spend that time on product development and growth instead of compliance paperwork.
The component traceability feature saved us during a supplier recall last year. We identified all affected products and lots within an hour. Without Fiddle, that would have taken days and we might have missed something.
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Join leading dietary supplement manufacturers who use Fiddle to maintain FDA compliance, manage production, and grow their business. Get started with a free demo today.