gComply Plus simplifies complex global regulations into an easy-to-identify Compliance Management Dashboard providing you with an effective and automated way to manage and control the compliance of your products.
gComply Plus provides a governance process to manage the development of products. It provides “what-if” analysis and can be integrated with the client’s own policies. gComply Plus is a logic-based solution that links to Decernis regulatory library to provide the authoritative source document supporting any conclusion. gComply Plus integrates with the clients own systems. It can be easily deployed as a remotely hosted system or as a module integrated with your product lifecycle management (“PLM”) system (e.g. Oracle, SAP, Siemens, SpecPage, etc.).
With gComply Plus you have the ability to:
- Prepare a chemical, material, ingredient, and product level compliance analysis
- Analyze and compare global threshold requirements for additives and contaminants
- Author global declarations of compliance for a product, material, or ingredient
- Manage change
- Search for and obtain information concerning global regulatory status and requirements
- Upload your formulations and recipes and analyze their compliance
- Provide an archive of compliance data and material acceptance processes utilized to support auditing and institutional memory
gComply Plus can also synchronize with all Decernis solutions to provide you with one seamless solution to manage and control your products and supply chains.
gComply Plus Modules
The Food Additives module contains a list of over 3,000 substances that can be added to human food as additives, flavors, vitamins or minerals. By choosing their functions and usages (food categories) in specific countries, a visual red /green matrix report can quickly be viewed. More details along with citations hyperlinked to the regulations cited are also at the fingertips of the regulatory professional.
The Contaminants module contains thousands of pesticides as well as a myriad of veterinary drugs, mycotoxins, heavy metals, marine biotoxins and microbiologicals. The maximum residue levels regulated in specific commodities are easily found by substance or by commodity.
You may also be interested in the Decernis Food Fraud Database.
The Standards of Identity module contains the required ingredients and physiochemical measurements needed to meet the chocolate and ice cream standards around the world. A recipe built in the recipe management module is submitted to a standard category to make the ‘go’or ‘no-go’ decision of whether the recipe meets the standard. If required ingredients are missing from a recipe, the missing substances report quickly shows what substances are needed.
The Recipe Management module provides the ability of the user to either build a recipe on the fly or upload a recipe via a spreadsheet. This module also provides the ability to nest one recipe within another and then decide whether to submit each individual recipe for Additive or SOI analysis or to explode the nested recipes and submit them together as one. When a recipe is submitted for Additive analysis, rules determine if the concentration levels of the additive ingredients meet their threshold levels both individually as well as in combination using molecular weight conversion factors when one substance is expressed as another.
Karen Everstine is Senior Manager, Scientific Affairs with Decernis, which delivers technology-enabled global risk management solutions for product development, compliance, safety, regulatory, and market access. She has fifteen years of food protection experience, most recently focused on supporting the food industry in their efforts to ensure food authenticity and compliance with GFSI food fraud requirements and the EMA-provisions of the Food Safety Modernization Act. She leads food fraud support at Decernis with the Food Fraud Database, a resource that collects and standardizes relevant food fraud data to support vulnerability assessments. She has previously held both research-based and applied roles in academia, government, and non-profit organizations, and has collaborated with members of the food industry and regulatory agencies on many projects, working with expert committees on this issue. She received her PhD and MPH from the School of Public Health at the University of Minnesota and began her food safety career on “Team D” at the Minnesota Department of Health. Her areas of expertise include a strong knowledge of the food regulatory landscape, food safety and authenticity. She has authored many peer-reviewed journal articles, trade journal pieces, and regularly responds to media requests.
Robert Fellous is Senior Director, Scientific Affairs with Decernis. Robert Fellous has more than twenty years of experience in Analytical, Clinical testing and Toxicology and Regulation, particularly with the cosmetics and personal care industry. Previously, in his work at Intertek, Dr. Fellous managed: Clinical Research Services with 35 professionals; Analytical Services Lab with 35 employee providing R&D and routine tests: contaminants & controlled ingredients, characterization & identification of nanoparticles, stability tests, packaging issues (migration of species, interaction between packaging and product), in vitro test (safety and efficacy) and microbiology tests; and Consulting Services Regulatory and Toxicology for Cosmetic and Pharmaceutical products with 25 professionals: e.g. preparation of PIF (Product information file), labelling review, electronic notification to European portal, safety assessment of cosmetic raw materials and API including complex raw materials such as botanicals, literature search, in silico study (SAR Modelling (Structure Activity Relation), design and optimization of toxicological protocols to meet global regulations, placement and monitoring of studies and submission of safety dossier to SCCS, INCI Dossier submission to PCPC).
Rich LeNoir has 37 years of experience in the industry. He currently works as a
In my current role, I serve as an advisor to various clients regarding food labeling as well as supplements labeling. Key activities include:
Kim Milone is an attorney and Senior Director of Regulatory Affairs for the Company, managing all research activities and the work of Decernis’ global research team. She also coordinates the work of the Global Advisory Services practice with that of the global research team. She has served as project lead and expert in Decernis projects with major food, beverage and supplement companies.
Julie Holt is a subject matter expert in the area of food, food ingredients, additives and supplements. She has more than twenty-three years of regulatory experience in the food and food ingredients industries and managed her own advisory firm, Scientific & Regulatory Solutions LLC, for a decade. During this time, her primary client was PepsiCo. Her food ingredient competencies include: flavors, sweeteners, colors, enzymes, probiotic blends, beverages, snack foods, juice, dairy products, supplements and fine chemicals. She has provided global regulatory coverage for more than 200 countries for various employers and clients including Givaudan Flavors Corp. and Degussa AG.
Mitchell Cheeseman has 29 years of experience advising manufacturers on compliance issues for a variety of FDA regulated products including food, food additives, GRAS ingredients, processing aids, color additives, dietary supplements and dietary ingredients, animal feed and animal feed additives, cosmetics, over the counter drugs and medical devices.
Henrik Jungclas is a Project Manager at Decernis, mainly focusing on Food Contact Projects, Supply Chain Management and Auditing. Prior to his recent position, he has worked as a Regulatory Affairs Manager and auditor for quality and hygiene standards at Tetra Pak, Weidenhammer and Sonoco Consumer Products Europe since 2006. He is a trained quality manager and Six Sigma Green Belt.
Kevin is co-founder of Decernis and is an experienced regulatory attorney who has worked and consulted for 24 years in the food and consumer products space. He advises some of the world’s largest manufacturers on Food compliance and Supply Chain challenges globally. Kevin is responsible for both the regulatory content of its products and its Subject Matter Expertise across the 219 countries Decernis covers.
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