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Regulatory Compliance

Integrated process automation solutions for regulatory compliance

The only way for global manufacturers to remain competitive is by increasing production and delivering high quality goods. However, failing to meet regulatory compliance standards is a major concern, especially for plants dealing with hazardous materials or regulated processes.

To remain compliant and avoid fines for violations, it’s important to understand emerging standards and the different requirements of regulatory bodies. Likewise, various process, documentation, audit and security controls need to be implemented to maintain proper risk management of compliance procedures, methodologies and data, which can be challenging.

iconsys has the process industry expertise to ensure the highest standards of safety and compliance. Forming part of our automation solutions package, we can deliver integrated process compliance systems and regulatory compliance consulting services to meet your exact requirements.

iconsys can help by:  

  • Achieving quality objectives and addressing issues, guidelines, and procedures using Compliance Risk Management methodologies
  • Using robust methodology to ensure management of change control and workflow procedures, applying best standards and practices to a project
  • Providing a flexible, risk-based approach to achieve compliance
  • Offering expertise on regulatory standards to ensure compliance is met and maintained
  • Planning corrective and preventive actions (CAPA)
  • Using data effectively over the entire product lifecycle from design to implementation, ensuring data integrity, along with secure accessibility and deliverability
  • Responding to inspections and audits using up-to-date data records and reporting
  • Performing internal audits prior to regulatory agency audits
  • Establishing policies, procedures and compliance records for analysis
  • Implementing integrated process compliance systems
  • Ensuring compliance with standards and regulatory bodies, such as:
    • EU directives e.g. Low Voltage Directive, EMC Directive, RoHS Directive, ATEX
    • BS/EN/ISO/IEC standards e.g. Functional safety standards BS EN ISO 13849, 61508, BS EN IEC 62061, Robot safety standard BS EN ISO 10218, Strip Process Lines BS EN ISO 15061, Presses BS EN ISO 16092
    • Other Standards – e.g. UL, CSA, DNV
    • Legislation – e.g. PUWER, LOLER
  • CE Certification, Marking and compilation of Technical File
  • Designing & constructing equipment suitable for incorporation into a certified Machine or Installation (e.g. Machinery Directive, EMC Directive)
  • Regulating computer systems based on specification and verification
  • Providing resources with quality, safety and environmental certifications (e.g. ISO9001, ISO45001, TÜV, ISO14001)
iconsys enhance performance through integration of automation technologies.
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