one of our capabilities within quality management
Document Creation and Review
Our Quality Management team is ready to solve your organizations needs regarding the creation and review of quality documents. Our services include:
Draft/document creation
- Generation of document relating to the establishment of new Quality Management Systems as well as the optimization of existing Standard Operating Procedures (SOP).
- Ensuring compliance with existing company SOPs and regulatory requirements.
- Generation of technical documentation for Summary Technical Documentation (STED) files.
- Development of user-friendly templates (optimization/re-evaluation of existing templates) based on Best Practice.
Document review
- Reviewing and improving quality documents by identifying document gaps regarding both business efficiency and regulatory requirements.
- Providing reviews of documentation and ensuring internal compliance to company standards.
- Independent reviews of quality documentation. If you need a second opinion or an actual 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. We also provide reviews and evaluation of the Documentation Package.
