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)