Embedded Regulatory Control Across the Product Lifecycle

For regulatory teams in the process industries, ensuring compliance across the entire supply chain is global, intricate and an ever-changing process. Tracking multi-country regulations against internal formulations, labeling and distribution means using disconnected software systems, performing time-consuming regulation lookups and getting only partial visibility into product data and internal processes.

The Devex regulatory module reduces this complexity by directly integrating compliance checkpoints into every stage of product research, development, formulation, labeling and distribution. Instead of tracking down insights, regulatory teams can reduce recall risks, improve internal safety, sustainability and operational standards across the supply chain and with just one system.

One-Stop Compliance Checks

Use one system for regulation lookups, formulation analysis and regulation control to significantly reduce regulatory tasks, react to new compliance issues quickly and compare how potential product decisions align with intricate regulatory requirements.

Increase Supply Chain Visibility

Pinpoint exactly where products are in the development process, track ingredient sources and use multi-layered formulation for deep visibility into product quality at every stage.

Easily Audit Global Regulations

Integrate global regulatory parameters  into product development and supply chain process and maintain consistent and accurate compliance audits across global product lines.

Standardize Safety Practices

Enforce new safety standards across labeling, shipping, ingredient sourcing operations and more to create high-quality, environmentally-friendly products.

Decrease the Cost and Time of Compliance

Gain immediate visibility across product lines, reducing time and cost spent tracking down information across departments and systems. Improve responsiveness to compliance concerns with complete insight into the manufacturing and distribution processes.

Full-Scale Formulation Compliance

Use one system to assess if legal ranges for product elements, internal safety, sustainability and operational standards are being met from R&D to final formulations.

Research and Development

  • Compare all possible raw material options against relevant regulatory standards prior to testing during the research and development phase.
  • Access a full history of past formulations to quickly update non-conformant ingredients or create more compliant versions of existing formulations.

Trial & Final Formulations

  • Perform compliance checks for additives, contaminant, pesticides, standard of identity, product type for country as formulations are created.
  • Add to and integrate additive, pesticide, contaminants regulatory data from the Selerant Compliance Cloud.
  • Complete go/no-go assessments against food additives and contaminants.

Formulation Reporting

  • See all the compliance details of a multi-formulation in one view instead of performing time-consuming analysis of individual substances.
  • Analyze product data compliance by product type, formulation, ingredient or country of origin or distribution.
  • Share evaluation reports across teams.

Complete Labeling Compliance

Speed time to market by ensuring compliant labels are generated from accurate product data within one system.

Pre-Set Country Requirements

  • Configure pre-set labeling criteria and generate labels for every country your distribution reaches.
  • Integrate customer-specific criteria into labeling to handle customer requirements.

SMART Labeling and Reporting

  • Generate product Ingredient Statements, Allergen Statements and Nutritional Facts based on data in product formulations.
  • Use label templates that contain fields for product data gathered through devices, sensors, research, legislative sources and from other validated data sources.
  • Get customized reports that contain product data shared with graphics teams for label generation and associated.
  • Connect labels to product specifications.

Benefits

For Regulatory Teams

  • Use a centralized system of food regulatory and safety knowledge to continually monitor compliance risks and updates.
  • Eliminate the need to manage multiple systems to get a complete view of process and product-level compliance.
  • Immediately access compliance requirements and country-specific requirements of regulatory bodies to simultaneously monitor or expand different product lines.
  • Create detailed compliance and product reports on activity around every stage of the product lifecycle.
  • Ensure regulatory processes are directly integrated into PLM processes.
  • Automate compliance checks and reduce human error.

For R&D

  • Perform simple compliance checks early in the development process for base percentages in formula, material, label specification product data objects and more.
  • Significantly reduce time spent assessing ingredient compliance and raw material sourcing.
  • Ensure product ideation and development includes quality requirements from the very start.
  • Develop compliant formulations that help expand sales in additional countries.

For Quality Assurance

  • Set safety threshold parameters for material masters.
  • Digitally manage the creation and submission of custom service documents for different country registrations.
  • Check internal sustainability practices against regulations from multiple countries.