Regulatory Compliance Systems & Services
To stay competitive in today’s global market, your facility must increase production and produce high-quality products, while meeting regulatory compliance requirements, including health, safety, and environmental. Non-compliance is a major concern, especially for those with hazardous materials or regulated processes in their manufacturing environment. Having a good understanding of emerging standards and the requirements of various regulatory bodies is necessary to ensure you stay in compliance. Managing regulated operations and data — and avoiding fines for violations — also requires a range of process, documentation, audit and security controls. But implementing these controls and maintaining proper risk management compliance procedures and methodologies is challenging.
MAVERICK Technologies® can help keep your operations safe and compliant. We bring extensive process industry expertise and provide a variety of automation regulatory system services as part of our Automation Solutions offering — delivering integrated process compliance systems and regulatory compliance consulting services to meet your specific needs.
We believe early engagement, upfront planning and transparent communication are keys to a successful collaboration. In the planning stage, we work together with your team to establish on-site, front-end loading (FEL) to fully understand the process and the compliance requirements your team faces. And because we’re platform-independent, we use the right solutions for your needs. Our Project Complete® methodology ensures we deliver an automation system that meets your objectives without sacrificing production or product quality. We develop a Project Execution Plan that details the project scope, team, schedule, risks with mitigation and communication plans, as well as a quality plan that defines the checks and balances needed to assure success.
- Achieve quality objectives and address issues, guidelines, and procedures using Compliance Risk Management methodologies
- Use Project Complete® methodology to ensure management of change control and workflow procedures, applying best standards and practices to a project
- Provide a flexible, risk-based approach to achieve compliant cGMP
- Offer expertise on regulatory standards to ensure compliance is met
- Plan corrective and preventative actions (CAPA)
- Use data effectively over the entire product lifecycle from design to implementation, ensuring data integrity, along with secure accessibility and deliverability
- Respond to inspections and audits using up-to-date data records and reporting
- Perform internal audits prior to regulatory agency audits
- Establish a chain of custody for analysis
- Implement integrated process compliance systems
- Ensure compliance with standards and regulatory bodies, such as OSHA, MSHA, Bureau of Energy Management, NFPA, ISA, IEC, FDA, EMA, GMP, EPA
- Comply with 21 CFR Part 11 requirements, GAMP V Model, and ASTM standards for manufacturers who need to meet FDA regulatory and consumer safety requirements
- Regulate computer systems based on specification and verification
- Provide resources with quality and safety certifications (e.g., PMP, TÜV FSEng)