A number of Environment, Health and Safety (EHS) software have modules or features used for regulatory compliance. Alternatively, there is stand-alone regulatory compliance software offered either as a separate application, or as part of a greater suite of EHS applications. While regulatory compliance software can vary widely from one solution provider to another, there are some elements mostly common to all, and that should be sought when evaluating regulatory compliance software.
Here are these elements:
- Support for standards widely adopted, followed and used by the industry such as: ISO 9000 (quality management systems), ISO 14000 (environmental management), ISO 31000 (risk management), and OHSAS 18000 (occupational health and safety management system).
- Identification and management of regulatory requirements, including permits, reports, etc., by country or region of the world.
- Access to regulatory content, such as legislative texts, compliance requirements as expressed by regulatory agencies, etc.
- Ability to measure compliance and produce compliance reports delivered to regulatory agencies, customers, suppliers, shareholders, industry peers, the public or other stakeholders.
- Management and planning of regulatory compliance audits, including scheduling, task assignments, tracking and reporting.
- Risk management capability to measure and assess the risks associated to non-compliance. This capability can be embedded in the regulatory compliance software or there can be integration between regulatory compliance software and a separate risk management module or system.
- Management of non-compliance, including actual and potential, with scheduling, assignment of tasks and responsibilities, as well as corrective and preventive actions.
- Change management functionality to have a documented history of regulatory compliance programs.
- Some capability to measure the costs of fulfilling regulatory compliance requirements. This can be something sophisticated where the costs are automatically calculated after inputting data, or as simple as entering the costs directly. The key is to have an idea of the costs year-on-year, to see if the business case of any product is being negatively impacted as a result of the costs associated to regulatory compliance requirements that need to be fulfilled for that particular product.
ENABLON
Enablon solutions help companies manage environmental and social performance, ensure compliance, minimize risks and improve profitability by leveraging some of the world’s most advanced technologies.
- Determine Applicability of Regulations
- Ensure Regulatory Compliance
- Improve Efficiency and Accountability
- Prepare for Regulatory Changes
METRICSTREAM
MetricStream provides Governance, Risk and Compliance (GRC) software solutions that allow companies across various industries to streamline and automate their enterprise-wide GRC programs.
- Reduction in the time taken to create and update policies
- Faster response time to regulatory changes
- More coverage on compliance and 90% control monitoring
- Reduction in the time taken to manage compliance activities
- Reduction in compliance follow-ups
- Improvement in case management cycle time
BWISE
Nasdaq BWise is the global leader in Governance, Risk and Compliance (GRC) Management software.
- Interactive role-based dashboard providing a consolidated view on your internal control program
- Through an intuitive interface, role-based views and inline tutorials
- Best practice configuration for immediate start out of the box or a jump start in your bespoke implementation
MASTERCONTROL
Document Control Software, Document Management Software Systems: quality and document management software for electronic document control, workflow, collaboration, electronic SOP, corrective actions, preventive actions CAPA, nonconformance for ISO 9000, ISO 14000, QS-9000 and FDA 21 CFR Part 11, GxP-compliant companies.
- Document control
- Change control
- Training management
- Corrective/Preventive Action (CAPA)
- Nonconformance management
- Complaints handling
- Audit management
- Submissions
- eProcess Automation
QUANTIVATE
Quantivate’s Governance, Risk, and Compliance (GRC) software solution enables you to effectively and efficiently manage your compliance, risks, and governance initiatives across the enterprise.
- Perform a risk assessment on regulatory changes to identify gaps in compliance and determine the priority of implementation
- Create compliance task management and automated workflows
- Map and apply all regulatory requirements to applicable policies, controls, and processes
- Demonstrate proof of compliance with comprehensive reporting capabilities
- Review how compliance changes impact the organization
INTELEX
Intelex cloud-based software manages environment, health & safety, quality and suppliers for regulatory compliance, and streamline ISO initiatives.
- Ensure ongoing compliance
- Automate your auditing process
- Reduce your compliance risk
- Turn insights into action
ASSURX
Quality Management System (QMS) Software + Compliance Management Software for regulated businesses. One versatile system simplifies + improves operations.
- Centralized
- Visibility
- Industry-ready
- Flexibility
- Control
INTELLECT
Intellect’s New Cloud BPM Software Platform allows you to automate complex business processes easily with no-coding, drag and drop app development capabilities.
- Streamline and automate your GRC processes and improve productivity
- Build a culture around compliance and ensure that everyone knows what to do and when
- Easily modify your applications to meet new regulations or your unique business requirements
- Work smarter with real-time visibility into enterprise-wide governance, risk and compliance
VERSESOLUTIONS
Verse Solutions provides Total Quality Management (TQM) Software that enables manufacturers of all sizes to mitigate compliance management. Features/modules include: Document Control, Employee Training, Corrective Action, Audit Management, Risk Register and Centralizes Reporting.
- Audit Management Software
- Complaint Handling Software
- Corrective Action (CAPA) Software
- Document Control Software
- Employee Training Software
- Nonconformance Software
- Incident Management Software
BPA-SOLUTIONS
BPA delivers ready-to-use, simplified regulatory software solutions – Quality, Risk, GDPR – to improve organizations’ processes, products and services.
- Leading softerware editor since 2001
- Location in Switzerland & USA
- 30+ man-years of development
- Hundreds of customers
- Swiss-made software
- Cost Effective
- Innovative
- Functional
- Flexible
- Easy
- Office 365 and SharePoint
- Effective team collaboration
- Scalable, secure, effecient
- Any deployment, no risk
- Any device, anywhere
- Higher return on investment
- Faster time-to-value