one of our capabilities within quality management
Document Creation and Review
Our Quality Management team is ready to solve your organization’s needs regarding the creation and review of quality management documents. Our services include:
Draft/document creation
- Generating documents related to the creation of a new quality management system as well as optimizing existing Standard Operating Procedures (SOP).
- Ensuring compliance with existing company SOPs and regulatory requirements.
- Generating technical documentation for Summary Technical Documentation (STED) files.
- Developing user-friendly templates (optimization/re-evaluation of existing templates) based on Best Practice.
Document review
- Reviewing and improving quality management documents by identifying document gaps regarding business efficiency as well as regulatory requirements.
- Providing reviews of documentation and ensuring internal compliance with company standards.
- Independent reviews of quality management documentation. Whether you need a second opinion or a full review, we can help you. This could be prior to submitting Technical File, a Design Review or when reviewing a new or updated quality management system.
- Reviewing and evaluating your documentation package, e.g. Summary Technical Documentation (STED) or other technical documentation before an audit or submission. Reviewing and evaluating your documentation package, e.g. Summary Technical Documentation (STED) or other technical documentation before an audit or submission.
