Compliance Requirements
Compliance means conforming to a rule, such as a specification, policy, standard or law.
It is important for organizations to keep track of all requirements that they should comply with, that way they can ensure 360 coverage in deployed policies and procedures.
Use this module to reference and document all Requirements that your organization need to comply with regardless of their type:
- Standards: Like the different clauses within the ISO 13485 or ISO 9001 standards for Quality Management.
- Regulations: Like relevant titles of the HIPAA Regulation.
- Internal Policies: Established by an organization to define internal system.
- Guidelines: Like the items within one of the guideline documents that the FDA issues to help related industries.
key features
key features
- Start with creating Compliance Reference records for each high-level requirement that you need to comply with (Example ISO 13485 Standard Reference)
- Within the compliance reference, create related records for each requirement (for example add all clauses within ISO 13485 Standard). For each requirement you can include:
o Key
o Title
o Description - Trace each compliance requirement back to Policies, Procedures, and Work Instructions that ensure coverage of the related compliance requirement. That traceability ensures that you have a solid process in place.
- Review, Approve, and Activate all Compliance References and Related Compliance Requirements.
- Start to use this module as a lookup for Compliance Requirements in other modules and processes. Examples:
o Reference ISO 13485 impacted standard in a Quality Issue.
o Reference a specific HIPPA Regulation in an Audit Checklist Template.
o Reference 21 CFR regulation in a procedure document.
- Fully compliant electronic signatures to capture approvals.
- Compliant audit trail to track changes up to the field level, with traceability on files.
- Configurable workflows and forms using leading edge No-Code designers.
- Built-in and integrated real time analytics solution that allows creating visualizations and dashboards.
- Cloud based and SaaS (Fully managed), which eliminates the need to deploy internal IT infrastructure, reduces your cost, and saves your time and effort.
- Implementation and data migration services to transfer your data from paper-based or other electronic systems.
