igwLAB – GMP Compliance Software
GMP-compliant Manufacturing Execution System for the botanical extraction industry with lot and batch control
igwLAB is a GMP-compliant, specialized manufacturing execution and quality tracking system (MES) built specifically for the hemp extraction industry. The igwLAB provides information to help manufacturing decision makers understand how current conditions on the plant floor can be optimized to improve production output. igwLAB software was designed to help extraction facility operations manage material and information flow. The process of extracting hemp biomass into CBD or CBG oils requires extraction equipment, distillation equipment, and formulations operations to finish goods such as vapor pens or CBD pills. The software includes thirteen unique individual modules that guides operators, quality managers, and laboratory personnel through the production process. The software creates master batch records for each step in the process so that maximum traceablity can be achieved and easily reported on.
Why igwLAB is Needed
There’s a lot of science intertwined with the extraction process. While you don’t need to be a chemist to execute, you do need a system that will help with tracking and recording critical quality data.
Each piece of equipment in your extraction facility uses factors like temperature, pressure, time, volume and weight to shape an end product, manage risk, and comply with a rule or regulation.
Extraction isn’t just knowing what buttons to press on a piece of equipment. It’s about tracking all the data so you can manage your production and tell it where to go instead of wondering where it went. This is crucial to your success as a manufacturer. As a busy entrepreneur, it is not possible to manage the complexity effectively with just a pen, a calculator, and a to-do list.
How igwLAB Will Impact Your Botanical Extraction Facility
If you purchased a full solution from extraktLAB, you know that each piece of equipment is part of something larger, and that each piece of equipment in that process was specifically selected to increase efficiency, eliminate bottlenecks, and ensure you don’t leave any money on the table.
igwLAB software and hardware stations throughout your facility measure the performance of each of these stages individually and collectively through 34 different reports utilizing nearly 100 data points. These reports give you the vital pulse of your extraction facility.
The stages included with igwLAB are Receiving, Milling, Decarboxylation, Extraction, Dewaxing, Distillation, Formulation, Isolate, Filling and Packaging, Shipping, Analytical, Sampling. Each stage configuration was built specifically to fill the complex needs of a botanical extraction facility. You can expect a greater degree of measure and monitor control over each of the factors that impact these stages.
igwLAB stations can be strategically placed throughout your facility to monitor your production line. The recommended minimum number is 3, but depending on the complexity of your facility, you can add additional stations. See example below.
igwLAB Features & Process Control Modules
- GMP-compliant Manufacturing Exection System with lot and batch control
- Cloud software platform with secure WIFI connectivity
- Yield optimization control
- Documentation and data repository
- Customer and regulatory reporting
- Supports multiple locations
- IOT integration with scales, scanners, barcodes, printers, and readers.
- At bench consumable replenishing
- Plug & Play
- Cloud Based
- Validation Controls – 21 CFR Part 11
- Custom Integration with ERP/MRP with API
- Complete Lot Traceability & Tracking
13 PROCESS CONTROL MODULES:
- Filing & Packaging
igwLAB KEY MODULES
- Step-by-Step Instructions
- Mistake Proofing
- Value Added Time vs Non-Value Added Time
- Documentation Control
- SOPs & Documentation Delivery
- Documentation & Quality Record Generation
- Cleaning, Calibration, Maintenance, and Quality Events Records & Documentation
- Sampling Module
- Analysis Request & Barcoding
- Reporting Module & Links to Batches & Lots
- Automated Batch Records
- Integrated BOMs
- Packaging Lot & Automations
Fantastic service: speed, competence, thorough, and follow-up. UniSci/extraktLAB has helped me build my start-up company at a break neck pace, all while ensuring quality. Best kept secret in the industry.
Great team and great machines.
I just think you guys have the best technology hands down.
Good knowledge of the complete cycle, the individual components that make up the system, many questions answered, technical, commercial, financial.
Frequently Asked Questions
How is hemp material transferred between areas to prevent contamination and material or batch mix up in hemp extraction?
Under GMP guidance, a risk assessment is conducted by management to identify those areas that are high risk for cross-contamination or batch mix up. Once the risk assessment is completed, process controls can be put in place to prevent contamination or Mix-Ups.
Sometimes the risk assessment might result in controls that can be as simple as a color coding or Designating a physical location for a particular material. More complex controls include in-process testing or double checks by quality assurance Durham Manufacturing.
Oftentimes the process controls and the process itself can be validated, with an approved validation protocol. Once the extraction method has been validated for mitigating the identified risk, cross-contamination and batch Mix-Ups typically only happen when process and procedure are ignored.
We use a software system called igwLAB to help us implement and mistake proof a validated manufacturing process. igwLAB is composed of both software and Hardware that works seamlessly together to give a full tracking solution where the movement of each lot or batch from one area is tracked with the software.
For example, a manufacturing process will not be able to process material without a release from quality assurance. Any attempts to do so will be flagged by the system and alert the operator to the mistake.
One thing that’s nice about the system is that it helps keep track of cleaning records and cleaning events for each piece of equipment that is put into the system. This can include tables, floors, ceilings, utensils, implements and Equipment. Any Surface that Can receive a barcode can be tracked in terms of cleaning events.
Standard operating Methods for cleaning these items are also stored in the software system so that the procedures can be readily accessed by the operator while the process is running. If the process calls for a cleaning event to be conducted, the software will not let the process proceed without cleaning for example.
How does this work with my ERP system?
We have a well documented API
We can give you a quote to integrate your ERP and the igwLAB API or you are free to develop it on your own
How much work is it to implement?
The implementation process will take 30-60 days.
Is there a warranty?
All hardware included with igwLAB has warranty of 1 year from date of purchase.
What training is included?
- Online training
- Installation of hardware
- Online support ticket system
What records does the system maintain?
Maintenance, calibration, cleaning, user, permissions, training, input weight, output weight, waste, vendors, biomass meta data, bill of materials, expiration dates, analytical results, sampling data, quality disposition, master batch record, standard operating procedures
What is included in the quality control module?
- Barcoded samples with location, batch, lot, location information along with sample data record.
- Sample testing request records.
- Sample testing results, reports, and automatic attachment to the batch or lot.
- Flag and alert system for out of specification or unexpected results.
Is igwLAB an ERP?
- Not an ERP
- Feeds data into ERP
- No financial functions are included in the software
- No costing is included in software
- Can show inventory location, weights of waste, inputs, outputs and counts of final goods
What is the difference between igwLAB and LIMS or laboratory information management system?
- A laboratory information system manages samples, users, equipment, continuous data, laboratory quality parameters, results, and reports.
- Does not manage overall quality.
What is the difference between igwLAB and process control software?
- Process control software records continuous physical parameters from manufacturing processes. The software continuously displays that data to show that the process is within pre-set statistical trends and confidence intervals. Process control algorithms built into the software use the data to adjust input independent variables to keep the process within said interval. Typically process control software is applied to complex multivariate processes or specific equipment.
- igwLAB records discontinuous physical, quality, lab data, SOPs, manufacturing actions, expiration dates, maintenance, events, locations, batch records, users, data and dashboards key process indicators.
How does IGW differ from other seed to sale software?
- Focuses specifically on manufacturing process
- Emphasis on batch records
- No POS attached to it
- No cultivation
What is the difference between igwLAB and METRC?
- METRC is a track and trace reporting tool for state systems
- igwLAB interfaces with METRC to via API
- igwLAB is different from Biotrack THC or MJ freeway as it is not a seed to sale system. The system does not have a retail or cultivation module.
Why do I need this software?
- Pulls all the processes, procedures, quality systems, and material movements together in one software.
- Provides data dashboards to manage and adjust business.
- Provides a single place (infrastructure) at each step of the process to record process parameters.
What does the software do?
- Reduces paperwork and human error
- Automates data collection on many routine tasks
- Automates quality records
- Manages production records and provides traceability
- Helps create logical workflow for each process.
- Provides the needed link between lab data and batch and process
- Document control
- Events manager
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