Using a third party compliance firm to provide your compliance services, offers many benefits over hiring one or more FTEs. A compliance firm can implement a compliance program quickly and efficiently with an experienced team that applies an industry-wide perspective.
Why Outsource Compliance:
Regulatory Knowledge
A reputable compliance services firm will provide the breadth of knowledge necessary to implement an effective compliance program. A group of experienced professionals will have more regulatory knowledge than any one person a company could hire.
Depth
A group of professionals work together to support a company’s compliance needs. They can draw on each other’s experience and knowledge. Also, their knowledge is not company-specific. A team can utilize cross-industry and diverse intelligence to serve each client.
Business Knowledge
A compliance services firm will have broad industry experience and apply it to the particular issues. A large team will have more industry knowledge than any one FTE.
Management and Turnover
When a service issue arises, the compliance firm can appeal to the firm’s management for corrective action. A firm, unlike a person, does not take vacation or sick days or ask for a promotion.
Cost
Based on our experience, utilizing a compliance services firm usually costs between 40%-60% of the cost of hiring comparable in-house resources. A consultant can also vary the services utilized to meet its budget constraints. Utilizing a compliance firm avoids the fixed cost (including benefits) and commitment of hiring FTEs. We bill our services on a monthly retainer, making it easier to budget.
How does it work
JJK will assign a staff member to serve as your point of contact: in effect your company’s regulatory Compliance Manager.
Your JJK Manager will schedule and lead all of your required GMP programs to keep you operating in full compliance with applicable US and international regulations.
Your JJK Manager will provide you with the expertise to ensure that your suppliers maintain a GMP compliant system that will meet your requirements — reducing the potential for receipt of non-conforming materials and customer complaints once your product enters the market.
We will visit your site regularly, as needed, to update local hardcopy files and complete other tasks that require presence on-site. We will be there at your request through inspections and Third Party Audits (for international approvals to market).
To maintain cost-effectiveness, many of the routine Compliance functions can be provided remotely: for example, we can conduct weekly CAPA and Complaint meetings via teleconference. Often we can propose and/or approve documentation changes through a secure site, and we will be available to you as needed, to answer questions and resolve problems remotely.
CONCLUSION
Using a third party firm to provide compliance services has become more accepted as more companies have seen the model work effectively. Outsourcing allows a company to access a deep compliance team, avoid the fixed costs and management issues of hiring an FTE, demonstrate compliance independence, mitigate liability, and lower costs. Doing nothing or delaying only invites regulatory, reputational, and, ultimately, business risk.
JJK Consulting & Compliance
The conversation starts here.
Developing and writing Quality Manuals, policies and procedures (SOPs)
Risk analysis, including FMEA and risk mitigation
Quality System training
Supplier Evaluation and Controls
Quality System audits and remediation (for the US, Canadian, European and international regulations for cannabis)
Design Control
Complaint and CAPA Management
Production controls, qualifications and validations,
Warehousing and Distribution controls
Management Reviews, and internal audits