Are lab notebooks legal documents?
Are lab notebooks legal documents?
It is important to understand that your lab notebook is a legal document. In the case that your research contributes to the issuing of a patent, it will be closely scrutinized because it documents your group’s claim to the discovery.
What should be included in a laboratory notebook?
It was modified from, “Writing the Laboratory Notebook” by H. M. Kanare.
- Introduction. Begin reporting an experiment by recording the date and title of the experiment on the very top of a new page.
- The Experimental Plan.
- The Observations and Data Section.
- Discussion of Results.
- Conclusion.
What is qualified laboratory documentation?
Qualified laboratory documentation consists of the industry certifications for any lab that was involved in completing validation testing. This could be for an in-house test lab or any offsite contracted test facilities that were used for validation or material certification testing.
Why is documentation an important GMP requirement?
Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and media used should be fully defined in the manufacturer’s Quality Management System.
What are acceptable documentation practices?
Requirements for GDocP/GRK compliance
- data accuracy. recorded accurately.
- data integrity/validation. genuine, true data.
- reporting/recordkeeping timeliness. information is recorded contemporaneously.
- legibility. clarity.
- identifiable. clear records that can identify the person who actually records the data.
What is the difference between a lab notebook and a regular notebook?
The lab notebook is usually written as the experiments progress, rather than at a later date. In many laboratories, it is the original place of record of data (no copying is carried out from other notes) as well as any observations or insights.
What is prohibited when keeping a lab notebook?
Do not:
- use binders, loose leaf or spiral notebooks.
- blot out or erase mistakes.
- modify the data.
- rip pages out.
- skip pages.
- leave a page blank.
- cover any writings in the notebook by affixing graphs and/or charts over them.
- write in the passive voice.
How do you structure a lab notebook?
GENERAL FORMAT
- Put your name, the course, and the term on the outside of the notebook.
- At the beginning of each lab session, write the date, your name, and the name of your lab partner at the top of the page.
- Write in ink. Cross out any mistakes with a single line.
- Leave all the pages in the notebook.
How do you organize a lab notebook?
Top 10 Tips for Organizing Your Lab Book
- Set Aside Time Each Day. If there is one key rule to organizing your lab book – this is it!
- Keep a Notepad on Your Bench.
- Use Templates.
- Number Your Pages.
- Have a Set Structure.
- Include More Detail than You Think You Need.
- Don’t Forget the Results.
- Make Notes of Anything Unusual.
What are the 18 documents of PPAP?
There are 18 documents that comprise the PPAP:
- Design Records.
- Engineering Change Documentations, if any.
- Customer Engineering approval, if required.
- Design Failure Mode and Effect Analysis (DFMEA)
- Process Flow Diagrams.
- Process Failure Mode and Effect Analysis (PFMEA)
- Measurement System Analysis Studies.
- Dimensional Results.
What are important documents in a model laboratory?
Personnel Files (education, experience, training, and continuing education)