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Internal Auditing is a structured and objective evaluation process conducted within an organization to assess the effectiveness of its operations, internal controls, risk management, and governance practices. It aims to ensure compliance with regulations, organizational policies, and standards, while identifying opportunities for improvement. 

SBS will help you analyze your business processes, identify areas for improvement, and develop strategies to achieve your business goals.

Supplier Audits are systematic evaluations conducted by a company to assess and ensure that its suppliers meet defined quality, compliance, and performance standards. 

SBS will conduct these audits to help establish confidence in the supplier's ability to consistently provide goods or services that align with the company's requirements and regulatory obligations. 

Regulations and Standards are essential tools used to establish guidelines and requirements for consistent practices, safety, quality, and compliance across industries, organizations, and governments.  

SBS will review your policies, procedures and practices to help assure you meet all applicable regulations and standards and get you are prepared for inspections.

FDA CFR Title 21 Part 820 is a section of the U.S. Code of Federal Regulations (CFR) that establishes the Quality System Regulation (QSR) requirements for medical device manufacturers. It is enforced by the Food and Drug Administration (FDA) to ensure that medical devices are safe, effective, and meet quality standards throughout their lifecycle. 

SBS will help ensure you meet these minimum requirements for designing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices to ensure consistent quality and compliance with regulatory standards. 

ISO 13485 is an international standard that specifies the requirements for a Quality Management System (QMS) for organizations involved in the design, production, installation, and servicing of medical devices and related services. 

SBS will help ensure that your organization consistently meets customer and regulatory requirements, focusing on the safety and effectiveness of medical devices. 

ISO 9001 is an internationally recognized standard for a Quality Management System (QMS). It provides a framework that organizations of all types and sizes can follow to ensure they consistently deliver products and services that meet customer and regulatory requirements while driving continual improvement.  

SBS will help ensure that your customers needs and expectations are understood, met, and continually improved upon. 

FDA 21 CFR Parts 210 and 211 are sections of the Code of Federal Regulations that establish the Current Good Manufacturing Practice (CGMP) requirements for the manufacturing, processing, packaging, and holding of finished pharmaceuticals. 

SBS will help ensure you meet these regulations pertaining to the safety, quality, and efficacy of drugs for human use in the United States. 

The EU MDR (Regulation (EU) 2017/745) is a regulatory framework established by the European Union to govern the safety, performance, and marketability of medical devices in the EU. It replaced the previous Medical Device Directive (MDD, 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD, 90/385/EEC) to strengthen regulatory requirements and improve patient safety. 

SBS will help ensure you meet EU MDR regulations to enhance patient safety, ensure transparency, improve device traceability and adapt to technological advances.

CMDR stands for the Canada Medical Device Regulations. These regulations govern the safety, effectiveness, and quality of medical devices in Canada. The CMDR is a part of the Food and Drugs Act and is enforced by Health Canada. 

SBS will help ensure you meet these requirements for the manufacture, import, distribution, and sale of medical devices in Canada to ensure they are safe for use and perform as intended. 

JPAL stands for the Japan Pharmaceutical Manufacturers Association (JPMA) Laboratory. This laboratory provides services for testing and ensuring the quality and safety of pharmaceutical products, including medicines and medical devices, in Japan. 

SBS will work to ensure you comply with JPAL standards and regulations required by health authorities.

A Quality System Audit is an independent evaluation of an organization's quality management system (QMS) to ensure that it complies with regulatory requirements, industry standards, and internal policies. Audits help identify whether the system is operating effectively and whether it aligns with organizational objectives, such as ensuring product quality and customer satisfaction. 

A Gap Assessment is a systematic evaluation process used to identify the discrepancies or gaps between the current state of an organization's operations, processes, or systems and the desired or required state, which is usually defined by industry standards, regulations, or best practices. 

SBS experts will perform Quality System Audits as well as Gap Assessments to provide insight into the organization's compliance status, help prioritize areas for improvement, facilitate smoother certification or regulatory inspections, promote continuous improvement and risk mitigation and assist in resource allocation for areas that need attention.

Mock Compliance Inspections are simulated audits or inspections conducted by organizations to assess their compliance with regulatory requirements, standards, and internal policies. The purpose of a mock inspection is to prepare for actual regulatory or certification inspections, such as those performed by authorities like the FDA, European Medicines Agency (EMA), or other regulatory bodies.

SBS can simulate the inspection process, identifying areas of non-compliance, weaknesses, or deficiencies before the actual inspection takes place. The goal is to proactively address potential issues to avoid costly penalties, delays, or disruptions during real inspections.

CAPA stands for Corrective and Preventive Action, a process used to identify, address, and prevent the recurrence or occurrence of issues in various industries, including manufacturing, healthcare, and quality management systems. CAPA is an essential component of quality assurance and regulatory compliance frameworks, such as ISO standards (e.g., ISO 9001) and the FDA’s Quality System Regulation (QSR). 

SBS experts will help with every aspect of CAPA including issue identification, containment, risk analysis, problem statement, problem description, scoping, investigation, root cause analysis, communication, action planning, action verification, effectiveness check planning and effectiveness verification.

Nonconformances refer to instances where a product, process, service, or system fails to meet specified requirements, standards, or regulations. These deviations may occur in manufacturing, quality control, compliance with regulatory standards, or customer expectations. 

SBS experts will help with every aspect of Nonconformance including nonconformance determination, type and evaluation as well as identification, containment, investigation and root cause analysis, corrective action, preventive action, verification and documentation and reporting.

CAPA Remediation refers to the process of revisiting, correcting, and improving existing Corrective and Preventive Action (CAPA) processes to address deficiencies, ensure compliance with regulatory requirements, and enhance overall effectiveness. It is often initiated in response to regulatory findings, internal audits, or identified gaps in the CAPA system. 

SBS will help to assess your current CAPA system, determine root causes, develop a remediation plan, implement changes, complete verification and validation activities, document and report and provide monitoring and continuous improvement.

Assessment of CAPA Systems and Procedures involves a comprehensive evaluation of an organization’s Corrective and Preventive Action (CAPA) processes to ensure they are effective, efficient, and compliant with relevant regulatory requirements and industry standards. 

SBS will help identify gaps, inefficiencies, or non-conformities within the CAPA system and provide actionable insights for improvement. 

Cleanroom and Controlled Environmental Controls refer to systems, protocols, and measures used to maintain specific environmental conditions to minimize contamination and ensure product quality, especially in industries like pharmaceuticals, biotechnology, semiconductor manufacturing, and healthcare. 

SBS will evaluate areas such as Air filtration, Airflow Systems, Environmental Parameters, Personnel and Equipment Controls, Cleanroom Classification, Particle Control, Temperature and Humidity Control, Air Pressure Control, Microbial Control, Access Controls and Monitoring and Alarms to help ensure proper conditions for processes and production.

Current Good Manufacturing Practice (CGMP) Requirements are a set of regulations enforced by regulatory agencies, such as the U.S. Food and Drug Administration (FDA), to ensure that products are consistently produced and controlled to meet quality standards. These practices apply to various industries, including pharmaceuticals, medical devices, food, and cosmetics, and are designed to safeguard public health by preventing contamination, errors, and defects in manufacturing processes. 

SBS experts will help ensure your organization has the proper processes in place including Quality Management System (QMS), Facility and Equipment Controls, Raw Material and Supply Chain Management, Manufacturing Process Controls, Personnel Training and Hygiene, Documentation and Record Keeping, Quality Control and Testing, Corrective and Preventive Action (CAPA), Validation and Qualification, Change Control, Product Complaints and Recalls, and Regulatory Inspection and Audits.

Quality Policy and Quality Objectives are foundational elements of a quality management system (QMS). They guide an organization’s commitment to quality, set strategic directions, and ensure alignment with customer needs, regulatory requirements, and business goals. 

A Quality Policy is a formal statement by an organization that outlines its commitment to quality. It serves as a high-level guiding principle for achieving and maintaining quality across products, services, and processes. 

Quality Objectives are measurable goals derived from the Quality Policy. They specify targets for achieving desired quality outcomes and support continuous improvement efforts. 

SBS will help your business formulate positive and endearing Quality Policies and Objectives showcasing your organizations Strategic Direction, Regulatory Compliance, Continuous Improvement, Enhanced Customer Satisfaction and Employee Engagement.

A Quality Manual is a comprehensive document that outlines an organization's Quality Management System (QMS). It serves as a high-level guide, detailing the organization’s approach to managing and maintaining quality, ensuring compliance with relevant standards, and meeting customer expectations. The quality manual provides an overview of policies, processes, procedures, and responsibilities related to quality management across the organization. 

SBS experts can help ensure your organizations Quality Manual contains the relevant information including Quality Policy, Scope of the QMS, Organizational Structure, Quality Objectives, QMS Processes and Procedures, Risk Management, Compliance and Regulatory Requirements, Documented Information, Continuous Improvement and Training and Competency.

Organizational Structure and Responsibilities refer to the framework within which an organization operates, detailing how tasks, roles, and responsibilities are distributed among its members. This structure ensures clear lines of authority, communication, and accountability, enabling the organization to achieve its goals effectively. 

SBS will help define your organizational structure as well as key roles and responsibilities pertaining to executive leadership, management, functional managers, team leaders and supervisors, employees and staff and quality assurance and quality control.

Internal Processes refer to the set of activities, tasks, or procedures that an organization performs to produce goods, deliver services, or achieve its objectives. These processes are typically internal to the organization and are designed to ensure operational efficiency, quality, compliance, and alignment with the organization’s goals. 

SBS experts will help ensure internal processes such as process design, process execution, monitoring and control, improvement and optimization, documentation and standardization are in line with organizational and regulatory expectations.

Continuous Improvement (CI) refers to the ongoing effort to enhance products, services, processes, and practices within an organization. It is a key philosophy that focuses on making incremental, small improvements over time rather than attempting large, disruptive changes. Continuous improvement aims to optimize efficiency, quality, and overall performance, leading to better outcomes for the organization, customers, and stakeholders. 

SBS will help ensure your organization is structured for Continuous Improvement focusing on ongoing processes, incremental changes, efficiency and effectiveness, employee involvement and data driven decision making with a customer centric focus.

Strategic Planning is the process by which an organization defines its long-term goals, sets priorities, and determines the best course of action to achieve those goals. It involves analyzing the current situation, identifying opportunities and threats, understanding internal capabilities and resources, and formulating strategies to position the organization for future success.

The strategic planning process helps organizations align their resources, actions, and efforts with their vision, mission, and core values, guiding decision-making and ensuring long-term sustainability and growth.

At SBS, we offer a range of consulting services that cater to your specific business needs. Our team of experienced consultants will work closely with you to identify challenges and develop tailored strategies for improvement. Whether you're looking to enhance operational efficiency or explore new market opportunities, we have the expertise to help you succeed.

Marketing and Sales are two interconnected but distinct business functions that work together to drive revenue, increase brand awareness, and build long-term relationships with customers. Both play a critical role in growing a company and achieving its goals, but they have different focuses and strategies.

Marketing refers to the process of promoting, advertising, and positioning products or services to meet the needs of target customers. It involves identifying customer needs, creating value, and communicating that value effectively to the market. The goal of marketing is to build awareness, generate interest, and create a strong brand that attracts and retains customers.

Sales is the process of directly engaging with potential customers to persuade them to purchase a product or service. Sales focuses on converting prospects into customers, closing deals, and generating revenue for the business. It typically involves one-on-one interactions, relationship-building, and personalized selling techniques. 

Our marketing and sales experts will help you develop and implement effective marketing strategies that will drive sales and revenue growth.

Operations Management (OM) is the area of management responsible for overseeing, designing, and controlling the production and delivery of goods and services. It involves the efficient and effective management of the processes that transform inputs (such as materials, labor, and capital) into outputs (finished products or services) in order to meet customer demands and business goals.

Operations management ensures that an organization's operations are running smoothly, cost-effectively, and efficiently, while maintaining quality and achieving long-term success.

We provide customized operations management solutions that will help you streamline your processes and improve your overall efficiency.

Human Resources (HR) refers to the department or function within an organization that is responsible for managing the people who work for the company. It encompasses a wide range of activities focused on recruiting, hiring, training, and developing employees, as well as managing compensation, benefits, and employee relations. The ultimate goal of HR is to ensure that the organization has a skilled, motivated, and well-supported workforce to meet its objectives. 

Our HR consulting services will help you attract, retain, and develop top talent, as well as manage your workforce more effectively.

Risk Management is the process of identifying, assessing, and controlling risks that may potentially affect an organization's ability to achieve its objectives. It involves systematic steps to understand the uncertainties and threats in a business environment, and to develop strategies to mitigate or manage those risks. The goal of risk management is to minimize the negative impact of risks, while also seizing opportunities that could enhance the organization's performance. 

We offer comprehensive risk management services to help you identify potential risks and develop strategies to mitigate them, ensuring the long-term success of your business.