|We re-purpose the company's existing compliance documents to support the FDA requirements saving companies money and effort. |
We ensure the documentation that directs the company processes follows the FDA pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. We know the ISO and FDA Current Good Manufacturing Practices (CGMPs) as defined by their regualtions and guidelines.
Our assistance includes product classification, premarket and postmarket requirements, labeling, manufacturing requirements (Quality system), import/export issues for medical devices and reporting requirements for electronic products.
We have sample documents and templates we can create for or you can customize for yourself.
We specialize in FDA compliance for medical devices and can answer these questions.
Where can I find which documents we need for FDA?
Which documents are required for EU inspections?
Does the FDA or EU require specific contents or formats?
Who is responsible for documentation?
What is the right format for each document?
Who should review, approve and sign documents?
Do we always need SOPs or can we use our installation and test scripts?
For how long should we keep the documents?
What is the best media for document archiving: electronic, paper or microfiche?
I want to archive my documents electronically, can I scan my paper and destroy the paper
How useful are document management systems?
Should they comply with 21 CFR Part 11?
We provide compliance to these requirements.
Documents required by the US-FDA
Documents required by international agencies
Developing an SOP for generation and maintenance of documentation
Handling electronic documents
Managing documents: Electronic vs. paper
Archiving paper documents electronically
Preparing documentation for national and international inspections
Compliance of electronic document management systems
Practical tips for writing documents
We give these examples.
- Master plans
- Test protocols
- Validation documents
- Batch records
- Training records
- Development and maintenance of SOPs
- Document management and control
- Development and maintenance of test scripts
- Scanning of Paper Records for GxP Compliant Archiving
- Retention and Archiving of Electronic Records
Regulatory reference documents
- FDA Drug cGMP: Requirements for Laboratory Records
- FDA Drug cGMP: Requirements for Manufacturing Records
- FDA CGP: Requirements for Clinical Trials Records
- FDA guidance documents and predicate rules