Introduction

When we think of a 21 CFR 820 Nonconforming Product, the first thing that comes to mind is a consumer who has been injured by a defective product. But did you know that many nonconforming products are not defective? The term “nonconformance” refers to any deviation from the requirements of 21 CFR 820.

This means that with every shipment that arrives at your warehouse, there’s a chance it will be rejected because it doesn’t meet your standards or specifications. When this happens, how should you handle these items? How can you ensure they don’t make their way into the marketplace?

What is a 21 CFR 820 Nonconforming Product? 

  • Nonconforming Product: A nonconforming product is any product that is not in compliance with the requirements of the product specification.
  • Defective Product: A defective product is one that was manufactured in a way that violates safety standards or fails to perform its intended purpose.
  • Substandard Product: A substandard product is something that doesn’t meet standard quality levels for its intended use.

Nonconformity can occur during all stages of production: design process; pre-production inspection; production process; post-production inspection; packaging/storage; shipping/delivery; installation

Process flow for 21 CFR 820 Nonconforming Product

21-CFR-820-Nonconforming-Product-Flow

21 CFR 820 Nonconforming Product

What is the classification of a 21 CFR 820 Nonconforming Product?

As with any regulatory term, there are a lot of ways to define a nonconforming product. But the most common one is a categorization based on risk level and how much testing needs to be done before the product can be sold. This classification system is called 21 CFR 820:

  • Class I (lowest risk) – No testing is required

  • Class II – Acceptable reportable products that require no more than visual examination only (e.g., toys)

  • Class III (medium risk) – Acceptable reportable products that require some additional testing or evaluation prior to sale (e.g., detergents)

  • Class IV through X (highest risk) – Highly toxic and carcinogenic substances such as radioactive materials used in medicine or research labs

Who is responsible for disposing and handling nonconforming products?

When it comes to disposing and handling nonconforming products, the manufacturer of the product is responsible for ensuring that it does not cause harm to humans or the environment. The distributor and importer of said product are also responsible for ensuring that no damage occurs.

If you are a manufacturer, distributor, or importer who has been issued with a recall due to a violation of 21 CFR 820, you must ensure that all products within your control are returned to your company for proper disposal. If this cannot be done immediately because there is not enough time before the deadline set by FDA, you may request an extension from federal regulators so as not to put consumers at risk unnecessarily.

How should the nonconforming product be segregated?

You should keep the nonconforming product separate from the rest of your products. You can do this by keeping it in a designated area, or by putting it into a designated container that is not used for other products.

When should a nonconforming product be rejected?

As a manufacturer, you must reject a nonconforming product if:

  • It presents a health or safety hazard.
  • It does not meet legal requirements.
  • It violates regulations.
  • It is in violation of contract specifications.

How to handle rejected products to prevent their entry into the market

  • Destroy rejected products.
  • Dispose of rejected products appropriately.
  • Document the disposition of rejected products according to applicable requirements (e.g., Federal Food, Drug, and Cosmetic Act).
  • Segregate rejected products from the nonrejected products until disposal is complete or further processing is required by law or regulation.
  • Track all actions taken with respect to the disposition of a rejected lot as appropriate for your facility (e.g., print labels; place them into shipping containers). Test all remaining inventory against specifications at least annually (or more often if necessary) to ensure that no other subpar lots exist within your inventory system and are not entering into commerce.*

What proactive actions can companies take to address nonconformance?

Let’s look at some examples of what companies can do to address nonconformance.

  • Talk with your customers and ask them what they think your company could be doing better right now, or where they think the biggest problems lie in their experience with your products or services. Use surveys, focus groups, interviews, etc., depending on how large or small of a number of people you want to talk to
  • Look at data from past products/projects and identify trends that suggest there may be issues with quality (e.g., if every product that’s been shipped has been returned due to defects).

3 regulations related to 21 CFR 820.90

  • 21 CFR 820.1: The FDA’s general rules for the regulation of drugs and biological products, including a description of the requirements applicable to each type of product, the conditions under which they may be distributed in interstate commerce, and their labeling.
  • 21 CFR 820.20: General requirements for drug production quality, including procedures to prevent contamination of starting material with microorganisms (including viruses). This also covers environmental monitoring; quality control unit; written standard operating procedures; reporting (including deviation reports); corrective action plans; complaint handling systems; and training records for personnel involved in manufacturing operations.
  • 21 CFR 820.90: Medical devices that are not tested or cleared by the FDA must be labeled with all required information about the device’s performance characteristics or limitations as well as any restrictions on use or warnings about potential adverse events.

Keep in mind that when it comes to 21 CFR 820, your action regarding nonconforming products can impact your company.

Keep in mind that when it comes to 21 CFR 820, your action regarding nonconforming products can impact your company. For example, if you choose to not follow the requirements of 21 CFR 820.100 and a product is recalled as a result of an inspection by FDA or another regulatory agency, you could find yourself facing civil or criminal penalties. It’s important for you to understand what your options are in terms of nonconforming product reporting.

We have also come across this PDF from the FDA website, check this out, it is very helpful.

Conclusion

The bottom line is that when it comes to 21 CFR 820, your actions play an important role in determining the future of your company. If you need help with Nonconforming products, Isolocity can definitely help. Get in touch with us and we will give you a live demo of how our software can help. 

Introduction

Health care organizations are learning that their ability to maintain quality of care is directly tied to the way they approach and address patient safety issues. The goal of this post is to teach you how to identify quality events, understand their root causes, and apply a systematic approach to preventing them from recurring.

Quality events and the triggers

Identifying quality events and the triggers that lead to them are critical to the success of any improvement effort. Quality events are patient harm, a near miss, or a failure to follow a process. These events can be identified by the people who experience them, or by the people who observe them.

Quality-events-and-the-triggers

You will want to look for quality events in your organization that can help identify where improvement efforts should be focused.

A quality event is an opportunity for change because they lead to an opportunity for improvement.

Root cause or causes of quality events

The first step to addressing a quality event is to develop an understanding of its root cause or causes. This includes:

  • Understanding the impact on patients and families
  • Understanding the impact on staff
  • Understanding the impact on your organization’s reputation among patients, other healthcare providers, and other stakeholders in the community

You can also do a 3×5 why analysis to find the root cause.

Not all incidents are quality events

To address a quality event, you must first understand what it is. The term quality event has two main definitions:

  • An incident that has occurred as a result of poor quality; and
  • A set of conditions that cause an incident to occur (quality-related).

The definition of a quality event trigger is the set of conditions that causes a quality event to occur (quality-related).

In addition, there are several types of triggers:

  • Quality Event Trigger – An event in which an individual makes a decision based on inadequate information or data. Example: A doctor gives you incorrect instructions because he did not have access to all your records before treating you for your cold sore. This can lead to worse outcomes than if he had read all your medical history before diagnosing and treating.

Address every quality event as if it could result in patient harm if it recurs.

  • It’s important to address every quality event as if it could result in patient harm if it recurs.
  • Make sure you are aware of the potential for recurrence, which means you need to know how often similar events occur in your practice and what factors increase their likelihood.
  • Make sure you’re aware of the potential for harm to patients because that will help you assess whether an event should be considered serious enough for further investigation or intervention.
  • If there is any possibility of harm to staff members, this should be a red flag for immediate intervention because it would affect other employees’ ability to do their jobs well and safely.

Isolocity has an entire module to address this concern. In our corrective and preventative action module, all erroneous actions are recorded. To prevent them from reoccurring in the future, a plan is also to be submitted.  Most of the tasks are also automated, for e.g. through real-time statistical process control, a graph is updated on your quality KPI dashboard as each part is inspected. This graph will indicate if machine maintenance is needed even before any waste is created.

capa-v1

Conclusion

Taking a proactive approach to quality events can help you prevent them from happening in the future and provide immediate action to reduce patient harm if they do occur. It is important to note that not all quality events are considered high risk, but as we have seen here today, sometimes even small problems can cause serious harm. Therefore it is critical to address every event as if it could result in patient harm if it recurs.

 

We are rated 4.6 on Capterra. Rate us on Capterra here.

Introduction

QMS Validation is one of the most important parts of a quality management system. It is meant to determine if the processes and procedures are meeting the goals set for them. In this blog post, we will go over what QMS validation is, how it works and why it’s important.

What is a QMS Validation?

QMS Validation is a process of checking that a system or process is compliant with a defined set of requirements. It’s an essential part of quality control, which refers to the various actions taken to improve the quality of goods and services.

A QMS Validation requires documentation about your QMS, documentation that describes how your QMS works and how it integrates with other processes in your organization (such as purchasing), as well as documentation from all relevant stakeholders who work in your organization (for example, managers).

QMS-Validation-Process

Define the validation requirements

The validation requirements, also known as validation statements, provide the foundation of your QMS. They serve as your justification for why and how you will validate that your system is working correctly.

The validation requirements are defined from three perspectives:

  • The quality management system (QMS) itself
  • The process(es) being validated by the QMS
  • The specific system or technical artifacts being validated by a particular process in a specific context, such as software code or infrastructure

Scope, objectives, and criticality of the process.

The scope, objectives, and criticality of the process need to be clearly defined. This will be useful in identifying gaps or potential improvements. The following information should be made available:

  • What is this process? (What does it do?)
  • What are its objectives? (What does it achieve?)
  • How important is it for the organization’s success? (How significant is it for the business’s success?)
  • Is it essential that you have this process running as efficiently as possible or can you live without it if necessary?
  • You could also consider whether there would be any negative impacts on other processes if your current one were not being carried out correctly.
  • Is this process compliant with our QMS/regulations/customer requirements and specifications?

Test the entire process.

Testing the entire process will ensure the system meets its requirement specification compliance. You can do this by following a defined process:

  • Test all processes in your QMS to ensure they continue to meet their requirements.
  • Give each process its own test plan, which includes test cases and sample data.
  • Execute each test case on the system using live data and monitor actual output against expected results to make sure the outputs are correct.

Test the entire system.

The last thing to do is to test the entire system as a whole. This includes testing from a user’s perspective, technical perspective, regulatory perspective and ethical perspective.

Test the requirement specification compliance.

You need to ensure that the requirements specified by your customer are in fact met and that your product or service meets the customer’s expectations. It is also important to conduct this type of validation during all phases of a project.

Follow a defined process!

The first thing to do is to define a process that you can follow. A good quality management system needs to be documented and has defined procedures, roles, responsibilities, schedules, and deliverables. The more defined it is the easier it will be for all involved in the QMS audit process.

Just do it.

Once you have a QMS in place, it’s time to validate it. Validation is the process of ensuring that your QMS meets its requirements. It is a systematic and objective method to determine whether your QMS is effective and suitable for its intended use. It should be conducted at regular intervals throughout the life of your QMS, at least once every three years after initial implementation, or when there are significant changes to the system (for example, new processes or products).

It’s important that you do this properly—a poorly executed validation program could lead to negative consequences down the line as well as damage internal credibility for other initiatives within an organization.

Conclusion

We hope that we have given you enough information about QMS validation and how to do it. If you are still unsure or would like more information, please feel free to contact us at any time. We look forward to hearing from you soon!

 

Rate us on Capterra.

Introduction

CloudQMS is a cloud-based quality management system (QMS). CloudQMS provides businesses with all the tools they need to manage their quality system. Isolocity is a CloudQMS as our software is available on the cloud and anybody from anywhere can access it. 

Ease of use

The cloudQMS platform is designed to be easy to use, configure, maintain and integrate with other systems.

  • The cloudQMS platform is a web-based solution that makes it easy for your users to access their data from anywhere at any time.
  • CloudQMS often is device agnostic, the UI renders on all devices nicely, be it mobile, tablet or desktop. Hence if you want to access the CloudQMS on the go, it should work fine. For e.g. when you access Isolocity software from a mobile or desktop, it will adjust its screen based on the device.CloudQMS-Feature-Responsive
  • Most cloudQMS would have integration with other cloud-based software which will help you manage your data. For e.g. Isolocity has integration with Elevated Signals, Leaf Logix and MJ Freeway. We also provide free API. Because of this dual entry of data would not be needed as multiple systems will be able to communicate each other.

Low up-front cost

  • There are no capital equipment, software licensing, and IT staff costs to consider.
  • You have no need to upgrade hardware or maintain it as needed.
  • When it comes to Isolocity, it gets even more affordable as we offer free training, unlimited implementation and support, we charge no activation fee and all SOPs are free too. Check our pricing to know more.

Disaster recovery

Disaster recovery is the process of restoring operations in the event of a disaster. It’s essential for companies to minimize the impact of disasters because even one disruption can be disastrous for business. CloudQMS provides disaster recovery by letting you easily replicate your QMS environment on-premises or in another location like AWS. This means that if there’s an outage at your data center, you can still access your QMS data and production systems from another location without having to worry about configuring new servers and setting up replication.

Flexible deployment model

One of the most significant advantages of cloudQMS is its flexibility. Depending on your business needs, Isolocity can provide you with a customized solution. Get in touch with us to know more.

Access to the latest features and functionality

As you can see, the cloudQMS is a highly flexible platform that allows you to deploy and use it in a way that works best for your organization. This means you’ll always have access to the latest features and functionality, including:

  • A user-friendly interface that makes it easy for anyone in your organization to use. The software is also highly scalable, so as your company grows or shrinks in size and complexity over time, the cloudQMS can grow with you.
  • Security features keep data safe from unauthorized access or tampering. You’re always in control of who has access to what—and when they get it!
  • At Isolocity we bring changes to our software every month to make sure that we are one step ahead.

Take advantage of the cloudQMS.

Cloud Quality Management System (cloudQMS) can help you do many things:

  • Enable compliance with ISO 9001, ISO 13485, or other quality certification requirements
  • Provide streamlined controls across several departments at once

Conclusion

Cloud QMS is the next step in quality management system technology. It offers a host of benefits that can help your organization improve its operations, reduce costs and increase efficiency. If you’re looking for a new way to manage quality, this is it!

 

We are rated 4.6 on Capterra. Rate us on Capterra here.

CAURD-License

In the past, we have discussed the entire step-by-step process for both New York Conditional Adult-Use Cultivator License and New York Conditional Adult-Use Processor License. As we are entering the third phase of Cannabis Legalization, the OCM opened the New York Conditional Adult-Use Retail Dispensary License (CAURD) Application window.

New York Conditional Adult-Use Retail Dispensary Applications (CAURD):

The New York Office of Cannabis Management (OCM) opened the Conditional Adult-Use Retail Dispensary (CAURD) application window on Thursday, August 25th. People affected by marijuana convictions have the first opportunity to open legal retail dispensaries in New York.

It’s the most important phase in the state’s hearty arrangement to make social equity visionaries the bedrock of New York’s marijuana market. Here, we make sense of who is qualifying for a CAURD permit, application prerequisites, determination models, and what occurs if you’re chosen for a CAURD license.

CAURD Permit Eligibility in New York:

There are two paths you can take to be qualifying for a New York CAURD permit. Candidates will either apply as a qualifying business or as a qualifying non-benefit. This blog will zero in on the prerequisites under the industry measures criteria. Both qualification rules should have no less than one person who meets the prerequisites of a social equity person. Social equity (justice-involved) individuals are defined as someone who:

  • Sentenced for a weed-related offense;
  • Whose parent, life partner, kid, legal guardian, or ward was sentenced for a weed-related offense; or
  • Who is subject to somebody who was sentenced for a weed-related offense

Qualifying cannabis-related convictions are those committed in New York State before March 31, 2021. Documented arrests that didn’t prompt a conviction are ineligible. Nonetheless, an individual might qualify to assume that they were indicted for different offenses they were captured for if the cannabis-related charges were eventually excused. Further, cannabis-related offenses probably abused New York State Penal Law. Convictions of government offenses are ineligible.

CAURD Qualifying Business Criteria:

Candidates applying as a qualifying business in New York should have a person who meets the accompanying models:

  • Justice-involved individual (portrayed previously);
  • Has qualifying business experience (possessed something like 10% of and controlled a business that was profitable for no less than two years);
  • Has sole control of the candidate (ability to arrange or coordinate the administration, directors, or strategies); and
  • Has critical presence in New York (residency, resources, genuine property, financial balance, or other association with or in New York State)

Justice-involved people should claim at least 51% of the cannabis dispensary permit. Various other justice-involved people can be essential for a similar application.  One person who meets each of the above rules should claim no less than 30% of the CAURD permit.

CAURD Application Documents:

CAURD retail licenses require at a minimum the following documents:

  • Evidence of being a justice-involved individual. Such documents include a Certificate of Disposition or other acceptable court documents or records of the marijuana-related conviction. Relatives must show a marriage certificate, birth certificate, or other acceptable documentation depending on the nature of the relationship, as applicable
  • Monetary reports, for example, tax records showing net profits and benefits of the company
  • Records showing a critical presence in New York, for example, ledgers, tax filings, property possession, or rent reports;
  • Proprietorship records of the qualifying business and of the candidate
  • True Party of Interest (TPI) exposure structures (disclosure forms)
  • Business plan (For a business plan in the Cannabis industry, we recommend taking help from Cannabis License Experts, check this page, Business Planning Solutions)
  • Monetary archives connecting to the candidate

CAURD Selection Criteria

The chosen applications for a CAURD permit will be those with the most noteworthy scores. Scores will be founded on the strength of the qualifying business criteria standards. It isn’t yet clear the specific scoring network. Notwithstanding, a few variables will impact candidates to get a higher score. For instance, marijuana-related convictions in regions influenced by over-policing or mass imprisonment might get a higher score.

Candidates will choose their main five territorial inclinations for a dispensary area separated as follows: Bronx, Brooklyn, Capital Region, Central NY, Finger Lakes, Long Island, Manhattan, Mid-Hudson, Mohawk Valley, North Country, Queens, Richmond, Southern Tier, and Western NY. The top-scoring candidates in every district will be chosen to push ahead and will be doled out to a dispensary area given through the New York Social Equity Cannabis Investment Fund.

What Happens After?

Following the application cycle chosen candidates will have a year to finish the excess application prerequisites to get final approval. Extra records incorporate but aren’t limited to submitting fingerprints and informing the neighborhood region among others of the results.

For more information on the New York cannabis License market, you might want to check this webpage, New York Cannabis License Solutions, we also suggest keeping an eye on our blog section where we keep providing updated information.

Legalization of cannabis in Germany

If you follow the Cannabis industry, you probably would know that lately, Germany has started moving towards legalizing adult-use of cannabis. According to Health Minister Karl Lauterbach, a draft law is scheduled to be ready by the end of 2022 for the legalization of cannabis in Germany.

As per the Health Minister, Germany has over 4 million adult-use Cannabis users which are about 5% of the population. If that number is to be put in perspective, as per cdc.gov, about 48.2 Million adults used Cannabis, at least once, in 2019 in the USA, which is about 18% of the population. This number in Canada is 17% as per canada.ca. But it is understood after the legalization of adult-use Cannabis in Germany, adult-use Cannabis users in Germany will grow.

In recent times Berlin has also experienced a pro-cannabis rally demand where around 500 Cannabis supporters gathered in Berlin and demanded faster action from the Government for the legalization of cannabis in Germany.

ICBC in Berlin, Germany

Given this context, this year International Cannabis Business Conference was held in Berlin which was an intelligent move.

We were fortunate to be a part of the biggest Cannabis trade show in entire Europe. Just like us, attendees flew from 85 different countries and gathered for a 2 day B2B conference in Berlin.

We were at booth 143 and it was a pleasure meeting with some old clients and friends. These photos below probably will give some indication about the fun we had. We met GlassHouse Botanics, NOC Pharma, RQC Pharma, Elevated Signals, and many other friends at the conference. We had some great discussions (some over drinks too) about the cannabis industry and the prospect of the same in Germany.

It was a pleasure to watch Mr. Burkhard Blienert, The Federal Government’s Drug and Addiction Commissioner, talk about the current complexities of the adult-use cannabis law in Germany and the entire Europe.

Discussion Points at ICBC

The 2-day conference was also packed with many other speakers and panels and we thoroughly enjoyed them. The discussions revolved around

  • Cannabis policy in Germany and how that can make an impact in Europe and the rest of the world
  • Emerging markets for Cannabis besides Germany
  • Complexities of the Cannabis industry concerning logistics, standardization, regulations, etc.

Takeaways from ICBC

After the 2 days event, we feel a little wiser. Some of the takeaways from the conference would be

  1. Berlin Subway system is way more advanced than Toronto (on a lighter note )
  2. The German medical cannabis market is driven a lot by distributors importing products from Canada and African nations.
  3. Recreational legalization is still a little ways away but the movement seems very positive.
  4. Portugal and Spain are hot markets.
  5. Having a fully validated GMP EQMS that is compliant with Annex 11 is a must to operate in the EU. So if you are planning for an adult-use cannabis business in Germany, we can help as we have 20 years of experience in GMP.

How-to-Apply-For-Cannabis-Adult-Use-Conditional-Processor-License-for-New-York

On February 22, 2022, Governor Kathy Hochul signed into law S.8084-A/A.9283-A, and as per law New York state now will provide conditional adult-use cultivator and processor license. The license holders will be able to cultivate, process, and distribute cannabis flower products holding an adult-use processor or distributor license, there are certain conditions to be met, which is why these license are conditional.

As the application period for Adult use conditional cultivation license ended, the Cannabis Control Board opened the application period for Cannabis Adult Use conditional processor license starting from 28th June till 31st August. Similar to Adult use cultivator license eligibility, active cannabinoid hemp processor license-holders are only eligible to apply for the adult-use conditional processor license. So if your name is not on this list, you can not apply.

One of the major aspects of this license is the business need to be GMP compliant as they will have to submit a GMP audit certificate at the time of filling up the application form itself. So in case, you have one, that’s good for you, if not, do get in touch with us. We have 20 years of experience in GMP consulting, we have our own GMP-validated software too. All you have to do is to fill up this form or WhatsApp us here.

But for those who are eligible, we will try to explain the prerequisites, other requirements, the process, ongoing responsibilities, and some FAQs for the Cannabis Adult Use Conditional Processor License application.

  1. Main Eligibility

    1. An active Cannabinoid hemp processor license holder from the office of Cannabis Management. The list is available here.
    2. Any Cannabinoid hemp processor license holder who applied for the license after 1st January is not eligible, i.e. if the Cannabinoid hemp processor license holder had applied for the license before 1st January, then only they will be considered.
    3. The person who will be applying must have more than 51% or more ownership of the Cannabinoid hemp processor license.
  2. Prerequisites

    1. Make sure your facility is GMP compliant. Once you submit an application, your facility will be inspected by the office. If you don’t have a GMP certificate, we can certainly help in this as we have 20 years of experience in GMP consulting.
    2. After you submit your application, you might be asked to perform hydrocarbon extraction activities for which you might need to use volatile solvents. Therefore the proactive measures would be to arrange a letter or equivalent from the local jurisdiction’s fire marshal, local building code authority, or its equivalent stating that the facility is approved to perform such activities and is compliant with all the fire codes and other regulations.
    3. If you have any pending/unresolved litigations, labor law, judicial, administrative, or regulatory violations, it will be better to resolve them first.
  3. Requirements

    These are sets of things that you need to provide at the time of application.

    1. Primary contact details of the applicant
    2. Business Location
    3. Business plan including the proposed Cannabis type(s)
    4. If the applicant is permitted to conduct extraction activities (as mentioned in the prerequisites), details of the proposed extraction method
    5. Compensation verification of the workers
    6. Proof of disability and paid family leave benefits insurance
    7. Proof of GMP audit (as mentioned in the prerequisites). If you need help, you can fill up this form or Whatsapp us, we have 20 years of experience in this.
    8. Ownership details of the applicant, you need to show you have at least 51% ownership of the Cannabinoid license.
    9. Financial disclosure
      • Organizational structure
      • Organizational charts
      • Capitalization table
      • Disclosure of existing or proposed sources of capital
    10. Your active Cannabinoid hemp processor license along with the proof that you applied for the same before 1st January 2022.
    11. The applicant’s attestation and agreement to the applicable terms and conditions, the same can be obtained here. Go through the entire document but only the last page is to be signed and uploaded at the time of application.
    12. Submission of non-refundable license and application fee – $2000.
  4. Process

    The process is entirely online.

    1. Sign in or create an account here.
    2. Fill up all the details mentioned below
      • Introduction – If you have any business listed on the portal, it will show up here. If you can see the business you are applying the license for, select it here, else select “my business is not listed”. Please note if you select an existing business, all previous details will be used.
      • Entity type – select from the dropdown – Individual/Sole proprietor, Partnership, or Corporation
      • Business Identification – All basic details like your name, legal name, EIN or SIN, etc
      • Business Address
        • Physical address – This is the registered business address.
        • Additional physical address – If you have multiple locations, just keep adding them here.
        • Mailing Address – Just make sure you have an established mail box at this address
      • Contact information – your contact details including telephone number, mobile number, email id, website etc.
      • Industry classification – Enter your North American Industry Classification System code. In case you don’t remember, you can check here or here. You should also add any secondary NAICS code in case you have one.
      • Owner/Business Principal
        • Sole Proprietor/ Owner details – If you have multiple owners, add all of them here
          • Title
          • First and last name
          • DOB
          • US Resident – Yes/No
          • SSN
          • Ownership percentage
          • Profit distribution percentage (if different from ownership percentage)
          • Phone
          • Email
          • Residential address
      • Person Authorized to submit this profile – Yes/No
      • Select the authorized person from the dropdown, this will be displayed on the license.
      • Primary contact information – select from the dropdown
      • Eligibility – Read and select yes for both the options
      • Proof
        • Enter the license number
        • Primary Location of the business
        • Upload the license certificate
        • Select type of license
      • Ownership Structure
        • Has a new entity been created for Adult use Cannabis processor license? – Yes / No (this is to understand if the same entity will have the Cannabinoid hemp certificate and adult-use cannabis conditional license)
        • Any unresolved or pending litigation or labor law violations? – Yes/ No, if yes, please provide details
        • Any judicial/administrative/regulatory violations?  – Yes/No, if yes, please provide details.
        • If the owner/applicant or any close relative is convicted of a cannabis offense, that is to be entered here
        • is the entity a new york state-certified minority/women/minority women/service-disabled veteran-owned business?
        • Upload organizational chart
        • Upload a copy of the entity’s capitalization. The table must show the ownership percentage of all owners, they should add up to 100%.
        • Upload all documents related to funding
        • Does this company have any parent companies, subsidiaries, affiliates, or any other predecessors of the applicant – Yes/No
        • Upload a list of names of all the financial entities the applicant or the predecessors has been a part of in the last 3 years
        • Does any of the owners have any interest in any other license in this jurisdiction?
        • Is there any linkage between any employee of the office of Cannabis Management with the applicant? If yes, provide all details.
        • Provide a short business description with all details about the business model (uploading a document is also allowed)
        • Do you intend to white label or co-pack for other cannabis cultivators or processors?
        • Do you intend to use other adult-use processors to white label or co-pack products for other cannabis cultivators or processors?
        • Do you intend to distribute cannabis products to licensed adult-use retail dispensaries?
        • Select the location that will be used for the processing or manufacturing
        • Processing location information – working hours
        • Upload the floor plan of the processing or manufacturing area
        • Control type over this area
          • Ownership
          • Leasing
        • Any other license by state or federal authorities related to the operation?
        • Any other business activities on this premise?
        • Extraction method details
        • Cannabis source information – details or source for cannabis extract
          • Business name
          • Entity type
          • License
          • Country
          • State
          • Telephone
          • Email ID
          • Website
        • Select the Cannabis product Type(s)
        • Do you have worker’s compensation insurance?
        • Are you exempt from worker’s compensation insurance? If yes, please upload.
        • If you have received the worker’s compensation insurance in last 30 days, that is to be uploaded here.
        • Any disability or family leave benefits insurance?
        • Are you exempt from disability or family leave benefits insurance? If yes, the same is to be uploaded.
        • If the disability or family leave benefits insurance exemption is obtained in the last 30 days, a copy of the same is to be uploaded.
        • Do you have a certificate of occupancy authorizing activities allowed under the adult-use conditional processor license? If yes, upload the same.
        • Upload the GMP audit certificate. Don’t have one? We can certainly help. Contact us through this form or Whatsapp us
        • Select the GMP audit standards
        • Date of GMP audit
        • If you have submitted anything so far which is your trade secret (if published publicly will cause harm to your business), that is to be mentioned here so that OCM can consider not publishing it publicly.
        • Did you get help from any legal counsel for the submission of this application?
        • Attestation – name, and initials
        • Download, read, and sign a copy of the terms and conditions and guidance for the adult-use conditional processor license
        • Payment is to be made by a cheque, details will be available at the time of applying, the fee is $2000.
  5. Submit the application

    1. Post this you will get a confirmation on the website as well as receive a mail in your inbox with the application ID which will be used for all future reference.
    2. Best of luck with your Cannabis Adult Use Conditional Processor License.

International-Cannabis-Business-Conference-Berlin

International Cannabis Business Conference – 2022 is Europe’s largest cannabis trade show. This year 5000 attendees are flying to Berlin from 80 different countries and Isolocity is one of them.

Germany in recent times has started taking steps toward relaxing cannabis laws. The government has already begun several weeks of expert testimony on liberalizing the use of recreational cannabis use. Health Minister Karl Lauterbach is hopeful that a new law will be presented in the coming months. However, recreational cannabis users want immediate action as they gathered in Berlin to mark 420, the annual cannabis celebration. During this time, ICBC, which is Europe’s largest Cannabis trade show, is expected to see good traction as this year it is happening in Berlin.

If you are interested to attend this conference, you can register here.

All details are given below,

Booth: 143, Venue: Estrel Berlin Hotel, Date: 19 & 20 July.

Feel free to RSVP to our Facebook, LinkedIn, or Google event.

We have also updated our key takeaways from International Cannabis Business Conference Berlin, check the same here.

 

 

Cannabis is a highly regulated industry and therefore keeping all aspects of the business compliant is very critical. We live in a digital era where more and more industries are shifting towards digital solutions and the same is true for the Cannabis industry as well. As a business replacing manual efforts with automation through software is essential as it reduces turnaround time, the margin of error, and most importantly, cost.

MES vs QMS vs ERP

Though there are many different types of software systems used in a cannabis facility, broadly speaking, they can be categorized into three buckets, mainly:

  1. Manufacturing Execution System (MES), some also call it Seed-to-Sale (S2S) – Mandatory
  2. Quality Management System (QMS) – Mandatory
  3. Enterprise resource planning (ERP) – Optional but preferred

MES-QMS-and-ERP

Elevated Signals and Isolocity are the most popular choices in the cannabis industry as MES and QMS respectively. 

In the past couple of months, the Isolocity and Elevated Signals teams have been working tirelessly to bring a new integration between the two software systems. 

Software integration plays an important role for businesses as it allows them to mitigate the risks of double handling data. 

What is Isolocity?

Isolocity is a QMS that documents and monitors processes, procedures, and responsibilities within a business while keeping companies in compliance with regulatory requirements.   

Isolocity offers quality management software to help a business stay in compliance no matter where you are located.  It uses GMP / EU GMP and other quality principles to allow companies to meet global compliance standards. 

Beyond regulations and standards, there are other benefits to using these systems.

They include:

  • Improved consistency
  • Less rejected batches and non-conformities
  • An uptick in customer satisfaction
  • Better efficiency in operations

Implementing a QMS with an integrated communications system lets you streamline the flow of data.  

What is Elevated Signals?

Elevated Signals is a Manufacturing Execution System (MES) that replaces fragmented systems of spreadsheets, paper, and legacy seed-to-sale software. 

Used by cannabis cultivators and processors, the platform enables fully digital cGMP batch record-keeping, granular inventory accounting, environmental monitoring, and data analytics in one central platform that helps companies improve production quality and performance.

Many MES or Seed-to-Sale software programs don’t have the features of a QMS system. Hence, the necessity for both systems in optimizing documentation and reporting for requirements. 

 

Isolocity

 

Elevated Signals

 

 

Objective

 

 

Eliminate all labor involved in Quality Compliance

 

Improving production quality and performance through digital transformation

 

Key Features

 

 

  •  Document & SOP Management 
  •  Corrective & Preventive Action (CAPA)
  •  Supplier Qualification & Tracking 
  •   Audit Management 
  •  Risk Management 
  •   Learning & Training Management 
  •   Batch Validation & Release
  • Granular cannabis and non-cannabis inventory tracking reporting for cultivators and      processors
  • Digital quality recordkeeping & fully paperless GMP batch records 
  • Environmental monitoring 
  • SOP execution 
  • Analytics & optimization

 

How does this integration help businesses?

By activating the Isolocity and Elevated Signals integration, businesses will be able to import their plant inventory and batch numbers from Elevated Signals into the Part Manager module in Isolocity. 

This will allow businesses to reduce the double-handling of data and therefore mitigate the risks associated with it.   

Businesses will be able to take advantage of this integration to easily complete their quality processes within Isolocity without worrying about double entering plant and batch information that is already stored in Elevated Signals.

The image below might give more clarity about this integration.

Elevated-Signals-Isolocity-Integration

How is this integration set up?

Isolocity’s development team will take care of the integration set-up, all the business would need to do is provide Isolocity with login credentials to Elevated Signals!  

The Isolocity and Elevated Signals integration will be able to help provide businesses with the tools they need to be successful.  If you have any questions about compliance and software that can help, we are ready with the answers you need. 

Lift-&-Co.-Expo-2022

 

Lift&Co. Expo is back and so are we. Catch us live at Booth # 1227 from May 12-15.

Schedule:

Lift Cannabis Business Conference : May 12

Lift&Co. Expo: May 13-15 Industry Days:

May 13-14 Consumer Day : May 15

Location:

Metro Toronto Convention Center

Canada’s #1 Cannabis Conference and Trade show returns, delivering expert insight and education, as well as the ultimate in business building networking and an expo floor showcasing hundreds of products, services, and industry innovations, all within a uniquely irresistible environment.

Visit us at Booth #1227 to learn how to automate GMP & ISO compliance and get significant time savings. You can also request a Free Demo to learn more about our automated GMP compliance software now.