Master Formula Management
Version-controlled recipes, BOMs and process parameters.
Master Formula Management maintains the approved recipe, bill of materials and process parameters that every batch record is built from, keeping every version under change control and traceable to its approval history.
What Master Formula Management delivers
A controlled path from start to closure
- 1Draft Recipe
- 2Define BOM & Parameters
- 3Review
- 4Approve
- 5Release
- 6Revise
Why teams move to Master Formula Management
Ensure batches always execute against the approved recipe
Prevent unauthorized recipe changes reaching production
Standardize formulas across sites and lines
Trace every batch back to the exact recipe version used
Cut recipe update turnaround through structured change control
Built for regulated operations
21 CFR Part 11
Electronic records and electronic signature controls — unique user identity, secure e-signatures and computer-generated audit trails on every record.
EU GMP Annex 11
Computerised system controls including access management, change control, data integrity and periodic review of the system.
GAMP 5
Risk-based validation approach, with pre-executed IQ/OQ documentation supplied with every release.
ALCOA++
Records that are attributable, legible, contemporaneous, original and accurate — enforced at record level.
OPS IQ is designed to support these regulatory expectations. Compliance is achieved together with your own validated implementation, procedures and controls.
Connected to your enterprise systems
ERP / SAP
Master data, materials and batch context exchanged over open REST and event APIs.
MES
Shopfloor execution events and equipment context linked to quality records.
LIMS
Laboratory results and specification data connected to quality decisions.
Identity Providers
Enterprise SSO and role-based access through your existing identity provider.
Enterprise APIs
Open REST and event APIs for custom and legacy systems.