Standards

Terema GRC helps organisations collect, connect, follow up and present structure, history, evidence and follow-up related to standards and regulatory requirements.

Support for structure and evidence

The system does not certify the organisation and does not replace the auditor’s judgement. It does make it easier to show how requirements connect to processes, risks, controls, actions, audits and documented evidence.

ISO 9001

Support quality management systems with processes, objectives, deviations, improvements, audits and management review.

ISO 14001

Connect environmental aspects, legal requirements, objectives, controls, incidents and follow-up in one shared structure.

ISO 45001

Collect occupational health and safety risks, incidents, actions, responsibilities and follow-up with traceable history.

ISO/IEC 27001

Link information security risks, controls, incidents, responsibilities and evidence to the management system.

ISO 13485

Support documented processes, deviation handling, CAPA, supplier control and validation for medical device environments.

ISO 42001

Structure governance, risks, responsibilities, controls and follow-up for AI management systems.

GAMP 5

Support a risk-based approach to validation, testing, change control and documented decisions.

CSV/CSA

Manage computerised system validation and assurance with focus on risk, evidence and verified use.

FDA 21 CFR Part 11

Support work with controlled history, access, audit logs and electronic records where the requirements are relevant.