Vitamin Manufacturer | Liquid Supplement Manufacturer | Skin Care Manufacturer
High Level cGMP Compliance
What most manufacturers recognized as an insurmountable obstacle to cGMP compliance, Healthy Solutions saw as an opportunity. Manufacturing is a system, cGMP compliant manufacturing is an exponentially more complex system and design, development and operation of complex systems are what the owners of Healthy Solutions excel at. High level cGMP compliance & True Finished Goods Quality requires exhaustive raw material analysis, extraordinary process controls and unparalleled access / transparency to the massive amounts of data collected at each step of the cGMP Manufacturing Process.
Exclusive access to our proprietary cGMP managment system
Healthy Solutions�, LLC offers a one of kind computer-driven Quality Control and production system designed to eliminate the human error variable during the manufacturing process. Many companies opt for �off-the-shelf� quality control systems that cannot deliver the level of technical sophistication necessary to deliver the best possible product to the consumer. We invest heavily in manufacturing technology and the professionals responsible for managing that technology. Our in-house staff of expert programmers are constantly updating and creating new product manufacturing programs and processes to assure that you receive the highest quality products on time, every time.
“Well done is better than well said.”Benjamin Franklin
10+ YEARS AHEAD OF THE CURVE
Preoccupied by the costs, time & energy necessary to bring their facility into compliance, manufacturers failed to consider the affect that cGMP�s would have on their clients. Healthy Solutions however, did the exact opposite. We knew that our ability to provide automated solutions could be a huge competitive advantage. We knew that the True Value of a Manufacturer 2010 or 2015 would be radically different from that of 2003. However, we didn�t know exactly how. AN EXHAUSTIVE REVIEW OF THE CGMP�S, FDA GUIDANCE DOCS, INTERVIEWS, RESPONSES TO INDUSTRY INQUIRIES, ETC�LED US TO THE FOLLOWING CONCLUSIONS:
A Manufacturers True Value will soon be defined by their ability to supply Brand Owners and Regulatory Agencies with the quality and quantity of data necessary to satisfy the requirements of Title 21 CFR part 111.
Creation and Implementation of Customized Systems will be the Key to Maintaining High Level cGMP Compliance and Providing Customers with the Aforementioned True Value.
10+ YEARS OF CUSTOM CODE
Healthy Solutions system continues to evolve. It�s a customer driven process wherein all of our clients are encouraged to ask for data or request system improvements / modifications. The Healthy Solutions team of IT professionals will review each requests, determine its feasibility, scalability and priority. If the request is something which may benefit the majority of our client base it will be prioritized for production. If it�s a customer specific request, you�ll receive an estimate for the cost of development as well as a timeline to implementation.
“We fail to see how any manufacturer could achieve high level cGMP compliance without a system of this sort.”Healthy Solutions Ownership
REVOLUTIONARY CGMP MANAGEMENT & TRANSPARENCY
Healthy Solutions offers a one of kind computer-driven Quality Control and production system designed to eliminate the human error variable during the manufacturing process. Many companies opt for �off-the-shelf� quality control systems that cannot deliver the level of technical sophistication necessary to deliver the best possible product to the consumer. We invest heavily in manufacturing technology and the professionals responsible for managing that technology. Our in-house staff of expert programmers are constantly updating and creating new product manufacturing programs and processes to assure that you receive the highest quality products on time.
More Valuable Than Ever
FDA�s inspection and enforcements of Brand Owners continues leave Brand Owners shocked and dismayed at the inability or unwillingness of their �cGMP Manufacturer� to Provide Tangible Proof of Compliance Sufficient to Satisfy the FDA. Furthermore, the FDA has been reaffirming the need for Brand Owners to maintain the quality and quantity of documentation necessary to meet the Brand Owner requirements of title 21 CFR part 111. The day may or may not come when you are in need of the information a responsible manufacturer like Healthy Solutions, LLC is able to provide. If you are not already contracting with Healthy Solutions, LLC we would strongly encourage you to review the Brand Owner requirements of title 21 CFR part 111, contact your current or prospective manufacturer with a list of required items, documents, reports etc. and see how comfortable you would feel with their response given that the FDA in your office making those same requests.
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SYSTEMS BUILT FOR SANITY
Our entire business model, systems and procedures are designed to ensure that every product we make, every action we take is monitored by our proprietary cGMP Process Management Software. There is no other system of this kind. For more than a decade, we�ve been working to ensure that when a challenge is identified, a process (program) is implemented to ensure that challenge never happens again. We can say with confidence that while statistically speaking we�ll never be perfect, so long as we work within the confines of the system there is little which can go wrong. No other manufacturer can offer you the same peace of mind. Computer controlled quarantine and material release. Computerized weigh out to prevent a small miscalculation from becoming a huge liability. Barcode controlled retention sample process. Automated recall procedures. And much, much more!
YOUR COMPETITIVE ADVANTAGE
Healthy Solutions�, LLC offers a one of kind computer-driven Quality Control and production system designed to eliminate the human error variable during the manufacturing process. Many companies opt for �off-the-shelf� quality control systems that cannot deliver the level of technical sophistication necessary to deliver the best possible product to the consumer. We invest heavily in manufacturing technology and the professionals responsible for managing that technology. Our in-house staff of expert programmers are constantly updating and creating new product manufacturing programs and processes to assure that you receive the highest quality products on time, every time. Complete material traceability from the receiving dock to the bottle via barcode scanning.
AUTOMATED COMMUNICATIONS
PO Confirmation
Customer Supplied Materials Needed
Customer Supplied Material Received
Shipping Confirmation w/ Tracking
Post Production Accounting
Ultra-Fast Access to Reports, Test Results
Healthy Solutions
“cGMP” Certified Competitors
Transparency and Reporting
Provides Raw Material Specifications
Provides Customers w/ Raw Material Test
Provides Customers w/ OOS Reports
Customer Supplied Inventory
Finished Goods Qualitative Analysis
Customer Specific Reports Available
Healthy Solutions
“cGMP” Certified Competitors
Automated Client Reports
Batch / MMR Raw Material Usage Reports
OOS, Deviation, Unexpected Events
C of A�s, Packing Slips, BOL, etc.
Pre-Production Acclerated Stability Reports
Finished Goods Qualitative Analysis
Customer Specific Reports Available
Healthy Solutions
“cGMP” Certified Competitors
QC LAB / ANALYTICAL
Inductively Coupled Plasma Mass
UPLC – Ultra High Pressure
Ultraviolet-Visible Spectrophotometry
NIR � Near Infrared Spectroscopy
Titrator � Automatic colorimetric
pH, Brix, TDS, Viscosity, Refractive
Healthy Solutions
“cGMP” Certified Competitors
All your gmp compliance information at your finger tips!
You can’t beat a quality conscious system designed to simplify all documentation required to remain cGMP compliant. Peace of mind and unequivocal quality are what makes Healthy Solutions the premier contract manufacturing partner. If you have any questions about our system or how we can easily plug into your existing system with our in-house team of IT experts, please click the button below and submit your information through the contact form. One of our IT specialist will follow up with you.
Plug and Play