Unique Compliance Offerings

Call us:
888-734-9778

Click here to visit our Compliance Blog

^{Take a Look at a Few of Our Unique Compliance Solutions:}

Compliance Behavioral Assessment Model™

Compliance Architects^®has developed an innovative methodology that can prospectively assess your corporate culture, and identify the organizational behaviors that will ultimately lead to compliance problems with one or more sets of regulatory obligations. Although procedures, systems, training and audits are important, without the right organizational behaviors, achieving your compliance outcomes is little more than just a wish. Using a proprietary, anonymous employee survey model, the Compliance Behavioral Assessment Model™ assesses your company's performance across six critical categories:

Training
Awareness
Knowledge
Intent
Culture, and
Capability

Results are weighted to identify critical risk areas. The results' analysis provides both objective and subjective insight and recommended action plans into what steps you can take to improve your weak, and risk-creating corporate characteristics.

HACCP Quality Plans

We have developed a unique quality and compliance methodology and resulting document we call the HACCP Quality Plan. Based on traditional HACCP principles, but expanded upon considerably, a HACCP Quality Plan can help your organization reduce risk, improve product quality, and substantially reduce the likelihood of an adverse regulatory inpsection. HACCP Quality Plans are cost-effective to develop, and can serve a myriad of purposes within your organization, including improving CAPA and other investigations, a master training document for your process operators, a recall reduction framework, and many more uses. The HACCP Quality Plan is a breakthrough tool for modern, risk-based quality management.
The Compliance Architects^® Three-Week Compliance Security Plan
(using YOUR internal resources)

Money is tight these days. Accordingly, Compliance Architects^® offers a three-week, fixed-price program that uses your internal resources to address identified compliance gaps. In essence, we perform an assessment / gap analysis of your operation, develop a remediation plan, staff it with your people, and then your team executes on the program. You get the benefit of our experience on identifying issues and developing plans, and your staff performs the work, reducing the amount of money needed to be spent on advisory resources. The program is structured as follows:

Week 1: Assessment and Compliance Gap Analysis
Week 2: Issue Prioritization & Plan Development
Week 3: Plan Assignment, Communication, & Execution Structure

We think this is one of the most cost-effective programs available anywhere to help your organization reduce risk at a minimal expense outlay.
Bioanalytical Quality System Audits (Are you ready for BQSI??)

Based on work done with the Bioanalytical Quality Standards Initiative, Compliance Architects^®can review your bioanalytical laboratory operations to determine whether you organization is meeting the emerging standards for bioanalysis in support of clinical trials. The FDA has been reviewing new guidance material and we anticipate increased enforcement in this area! Bioanalytical Quality
Enterprise Compliance Program Operating Framework

Derived from the Department of Justice's "Seven Elements" program, but expanded upon substantially, our Enterprise Compliance Program Operating Framework provides a robust architecture for successful enterprise risk management. Incorporating principles such as knowledge management, regulatory intelligence, governance systems and process risk mapping, we can create a compliance architecture that keeps current with changing compliance requirements, while integrating fully with your organizational structures. The "Seven Elements" program is a great start, but it can't be considered a robust operating program. We're confident these principles will be a worthwhile investment in your company's compliance activities.

Compliance Architects^®: Innovative, business-focused compliance for FDA-regulated industry.