Quality Management Services (QMS)

Are you sure your business is compliant? What is the quality of raw materials from your supplier? Are you consumers satisfied with your product?


Facilities site Audit

Ensuring your facility is compliant with current version of CA cannabis manufacturing regulations: CCR Title 17, Div. 1, Ch 13 [DPH-17-010]

Add-on available for compliance with FDA dietary supplement current good manufacturing practices (DS cGMP): 21 CFR 111 (leading paragraph)

  • Site plan compliance assessment

  • On-site physical inspection / compliance assessment (grounds and building)

  • Inspection summary and detailed observation report (inclusive of criticality rating and

    pictures, if applicable)

  • Recommendations for observation resolution and/or mitigation

  • Follow-up inspection to assess resolution / mitigation efforts (within 90 days)

BUSINess operations Processes (BOP) Audit

Ensuring your policies and procedures (P&P) are compliant with current version of CA cannabis manufacturing regulations: CCR Title 17, Div. 1, Ch 13 [DPH-17-010]

Add-on available for compliance with FDA dietary supplement current good manufacturing practices (DS cGMP): 21 CFR 111

  • Policies and procedures (P&P) architecture review and assessment

  • Business Operations, Quality Control / Assurance, Technical Safety and Maintenance P&P review and compliance gap analysis

  • Assessment summary and detailed observation report (inclusive of criticality rating)

  • Recommendations for audit-friendly policy and procedures architecture

  • recommendations for resolution and/or mitigation of identified compliance and best

    practices gaps

  • Follow-up inspection to assess resolution / mitigation efforts (within 90 days)

Product audit

Ensuring your products and procedures (P&P) are compliant with current version of CA cannabis manufacturing regulations: CCR Title 17, Div. 1, Ch 13 [DPH-17-010]  

  • Physical inspection of all finished good product lines (inclusive of product type, labeling and packaging)

  • Inspection summary and detailed observation report (inclusive of criticality rating and pictures, if applicable)

  • Follow-up inspection to assess resolution / mitigation efforts (within 90 days)

QMP/S Maintenance

Maintaining your overall compliance with current version of CA cannabis manufacturing regulations: CCR Title 17, Div. 1, Ch 13 [DPH-17-010]

Add-on available for compliance with FDA dietary supplement current good manufacturing practices (DS cGMP): 21 CFR 111 

  • Develop internal audit schedule

  • Set-up, install and train internal audit team (up to 5 people)

  • Monitor, provide recommendations / consultation for internal audits

  • Conduct annual and/or regulatory updates QMP review and develop improvement recommendations

GET COMPLIANT.

Contact us now.

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ADDITIONAL SERvices

F-BOM Services

Our comprehensive list of services that can help you run your business from start to finish. We partner with you to ensure continued success.

 

F

Feasibility

Business Concept/Risk Assessment
Help you determine whether or not your idea will be profitable based on industry knowledge and data.

Business Roadmap Workshop
Align on your MVV, develop your entity structure, validate your business model, ensure appropriateness of Operating Agreements and Resources to succeed.

Financial Analysis
Determine what your first 18 months in business will look like.

Investor Package
Ask the tough questions before your potential investors do. As well as develop and create your investor presentation.

O

OPERATE

Business Administration
Maintain business infrastructure as described in Build.

Accounting
Provide comprehensive accounting services including bookkeeping, corporate and owner tax filing, and responding to unexpected IRS correspondence.

Regulatory Compliance
Ensure compliance will all regulatory bodies and save you from costly fines.

Contract Management
Create, ensure compliance, control, and amend as necessary. Ensure you are meeting your obligations and hold others accountable to remain compliant with the terms. These contracts include business operations contracts, purchase orders, service contracts, and more.

Supply Chain Management
Create and regulate production schedule for business, analyze where performance does not follow the schedule (deviations), manage Corrective Action and Preventative Action (CAPA), as well as provide Quality Assurance and Control.

Business Performance Analytics
Identify, develop, collect and analyze metrics for optimal business performance.

Executive Management Consulting/Advisory
Identify, develop, and solidify the goals and mission of your business. As well as meet with your business stakeholders to review and reconcile goals and budget from previous year, and revise and develop goals and budget for the new year.

B

BUILD

Business Administration
Set up every aspect of your business infrastructure such as business entity, required permits, business licenses, insurance, utilities, domain, org. charts, contracts, and more.

Human Resources
Develop all on-boarding and off-boarding processes and requirements for employees such as employee handbook, job descriptions, contracts, time tracking, benefits, and job training.

Accounting/Finance
Establish EIN to start, then implement or update payroll processing, bookkeeping, expense reimbursement processes, inventory management systems/processes along with required training for each.

Regulatory Compliance
Conduct required Audits and manage all mitigation and observation activities. Conduct regular training as required by OSHA, Labor Laws, and Cannabis Regulations.

Quality Management (QM)
Develop your Quality Plan and Policies and relevant procedures including Employee Training, Out of Specification Management, Deviations, Market Complaints, Supplier Management, Event Tracking, Corrective Action/Preventative Action, Quality Risk Management, Audits, Metrics (KPIs), and Document Control.

M

MANAGE

MVV
Develop your MVV over the maturation of your business enterprise.

Finance
Create and manage budget cycle and major financial decisions.

Application of Analytics
Analyze and apply results to optimize your business.

Goal Setting
Help you fine-tune your business goals over time.

Business Strategy Development
Develop next steps for your business.

Marketing Strategy Development
Connect you with best-in-class marketers.

 

We work with you on customizable packages or hourly rates.

 

We work with you every step of the way, no matter where you are in your business journey…