Regulatory Compliance

Integrated Process Automation Solutions for Regulatory Compliance

To stay competitive in today’s global market, your facility must increase production and produce high-quality products, while meeting regulatory compliance requirements, 包括卫生, 安全, 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, 文档, audit and security controls. But implementing these controls and maintaining proper risk management compliance procedures and methodologies is challenging.

特立独行的 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.

The 特立独行的 Approach

We believe early engagement, upfront planning and transparent communication are keys to a successful collaboration. In the planning stage, we work together with your 团队 to establish on-site, front-end loading (恶魔) to fully understand the process and the compliance requirements your 团队 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, 团队, 时间表, risks with mitigation and communication plans, as well as a quality plan that defines the checks and balances needed to assure success.

特立独行的 can help:

  • Achieve quality objectives and address issues, 的指导方针, 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 (卡帕)
  • 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, 矿山, Bureau of Energy Management, 美国, ISA, IEC, 食品及药物管理局, 教育津贴, GMP, 环境保护署
  • 遵守21 病死率 Part 11 requirements, 大伞 V模型，和 ASTM standards for manufacturers who need to meet 食品及药物管理局 regulatory and consumer 安全 requirements
  • Regulate computer systems based on specification and verification
  • Provide resources with quality and 安全 certifications (e.g., PMP, 德国莱茵 工程师协会ng)

Regulatory Compliance System Expertise

We’ve helped customers achieve regulatory compliance across industries.

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