From formula to market: how to specify regulatory management software
Regulatory management is a data problem. Every product must use permitted substances, carry the correct hazard classification, ship with a current SDS and label, and meet the rules of each market, and the formula data provides the evidence. From formula to market is a handbook for teams preparing an RFP or URS for regulatory management software.
Many companies keep that evidence in spreadsheets, supplier PDFs, shared drives, email, and specialist memory, so every compliance answer takes manual work. Regulations work at substance level: REACH and CLP require knowledge of product substances and concentrations, the US Hazard Communication Standard sets a 16-section SDS format, and GHS provides the classification and labeling model that countries adopt with local choices.
What should a regulatory management software RFP or URS include?
A regulatory management software RFP or URS should include requirements for substance and raw material data, formula composition and substance rollup, regulatory list screening by market and use, hazard classification, SDS and label authoring, change impact, customer requests and declarations, audit trail, and integration with R&D, PLM, ERP, and quality systems. It should also cover governance, regulatory content ownership, and data migration.
Ask suppliers to demonstrate one complete workflow with your own data: load a raw material from its supplier SDS, use it in a formula, calculate the substance-level composition, screen the product against market lists, classify it, and publish the SDS and label. Regulatory management in Uncountable keeps each answer traceable to the formula, the raw materials, and the rules that applied on that date.
Who this handbook is for
Regulatory affairs, product stewardship, R&D, quality, IT, and project sponsors preparing an RFP or URS for regulatory management software.
For a one-page overview of how Uncountable approaches this, read the solution brief Regulatory Management: compliance checked in the recipe.
What's inside
Inside this handbook:
- How to move from a document store to a regulatory system, and the regulatory data model behind it
- Requirements for substance and raw material data, including supplier SDS ranges and confidential components
- Requirements for formula composition and substance rollup through intermediates, ranges, and process losses
- Requirements for regulatory list screening by market and use, with list versions and match evidence
- Requirements for hazard classification, SDS authoring, labels, and multi-language output
- Requirements for change impact, customer questionnaires and declarations, audit trail, and system integration
- A supplier demonstration scenario and common mistakes for each chapter
- Implementation and governance requirements, plus a final evaluation checklist
Download the handbook to specify a regulatory system that gives every compliance answer a traceable path from formula to market.
FAQs
From formula to market is a handbook on how to write a practical RFP or URS for regulatory management software. It covers substance and raw material data, formula composition and substance rollup, regulatory lists and market screening, classification, SDSs and labels, change impact, customer requests and audit trail, and integration with R&D, PLM, ERP, and quality systems, with supplier demonstrations and common mistakes for each.
The handbook is for teams preparing an RFP or URS for regulatory management software, including regulatory affairs, product stewardship, R&D, quality, IT, and project sponsors.
Regulations such as REACH and CLP work at substance level, so every compliance answer depends on knowing which substances a product contains and at what concentration. When that evidence sits in spreadsheets, supplier PDFs, and email, each answer needs manual work to find raw material compositions, calculate concentrations, and check lists, and problems appear late as portfolios, suppliers, and lists change.
A regulatory management software RFP or URS should include requirements for substance and raw material data, formula composition and substance rollup, list screening by market and use, hazard classification, SDS and label authoring, change impact across the portfolio, customer questionnaires and declarations, audit trail, and integration with R&D, PLM, ERP, and quality systems.
Regulatory lists name substances, not trade-name raw materials. Screening against raw material names misses substances that appear inside mixtures, intermediates, or supplier ranges. A regulatory system should roll formula composition down to substance level, screen those concentrations against each market's list version, and show the match evidence behind every pass, fail, or data gap.
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