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.
