“…if it isn’t written down, it wasn’t done.” Food And Drug

Administration(FDA) Handbook

Legal Scientific Laboratory Notebook

You must use a black and white composition laboratory notebook

with waterproof black ink. A sharpie or a black ballpoint per will work.

Essential Skill for Biotechnicians is documentation in a Legal

Scientific Notebook

What is the proper technique for a legal scientific notebook? to record what an individual has done, company audits for GMPsTo establish ownership for patent purposes and other legal usesTo establish criteria used to evaluate a finished product quality or the process to make the productTo trace manufacturing of the product or establish verification or liabilityTo create a contract between a company and consumer and/or between a company and regulatory agencies to prove that a procedure was done correctlyTo adhere to, evaluate, and develop standard operating procedures (SOP)To be used in a legal investigation, criminal investigation, or in a court of law

The Documentation Process

Safety, Equipment, Facility, Materials, Procedures/Process, Data, Analysis, and Conclusion used and validated use in the correct manner allows companies to assure proof of Good Manufacturing Practices (GMPs).

If the information is not entered legibly, or information is missing, companies can be fined or the company may be held liable for damages in a product lawsuit.

In Research and Development labs, the same careful documentation is necessary to establish rights to valuable patents.

Within the same company different departments may have a different formats and rules in regard to your notebook and lab report formats so my way is not necessarily the highway.

Your Laboratory notebook will be graded throughout the course and the sum total of the grades will consist of 45% of your final 6weeks grade.

General Rules for Writing Legal Scientific Laboratory NotebooksWrite all parts of the lab in black waterproof ink –

WRITING IN PENCIL IS FORBIDDEN

If you make an error draw a single line through it, initial and date it. Enter your corrections in clear and legible writing.If your writing can not be read it is considered nonexistentBe specific and add details that have bearing on your resultsNever cover up data with another piece of paper, even graph paperWhen taping information in tape all four sides then write NWUI no writing under insert on the bottom right corner of the tape, your initials, and the date.Be factual, concise, clear, and complete in all aspects

COVERFirst and Last NameInstitutionStart date of lab book or start date and volume number(End Date of last page will be added when last page is reached)

Classroom Lab Reports3 PARTS

1.Pre-Lab This is to be completed prior to experimentation2.Lab Notes S.O.P. Established Standard Operating Procedures3.O/C Observations and Comments you may want to remember or convey to others may be footnoted or end noted4.Analysis Calculations, Conclusions Drawn, Summary Questions or Specific analysis questions assigned

PRE-LAB WRITE-UPHeading at the top of a new page to include:

Name of labDate of labName of student

A short description of the purpose of the lab:This may be done as an objective, purpose, assay

Safety specifics for the lab (general safety is understood)

Materials and Equipment listProcedure - Detailed list of Steps in your own words

leaving a full space in between each numbered step. (You may type and print pre-lab information but you must follow proper taping instructions.) Re-write allows for familiarization of procedures preventing mistakes and wasted time.

PRE-LAB cont.Write pre-labs only on the left page onlyRight pages will be used for recorded notes , data,

results during lab.If your pre-lab is typed you must format it to fit the

page and have no paper hanging over the edges after taping.

The SOP should have only information limited to the lab and should not include the additional information, such as background or history, that handouts will have. This additional information is there to assist you in the learning of material or techniques and should not be included on the pre-lab. (Extract only actions required out of the material.)

Pre-lab finishedGauging the amount of detail you need in a

pre-lab will come with practice. If it is too long it will be cumbersome to use. If it is lacking uniformity for others to follow, it will be difficult to create repeat performances which is needed for routine accuracy within a research study.

During LabPre-labs will be checked off just as your supervisor in a

work place will check your procedures.During lab you will write everything down in black ink to

the right of the procedures. This includes supply lots on reagent containers, dates opened, what balance you used, time frames including intermittent times, etc.

Changes that are made to the procedure need to be documented and always, ALWAYS, show calculations and units.

This documentation may be proof to where something went wrong or possibly a link to a new discovery.

Each team member will write their own notes and data.

ConclusionRestate the purpose/objective/assay etc.Restate the data and analysisExplain and sources of errorHow would you improve the

technique/lab/procedure/source of error et. al.

State what was learned as a result of the research. (This is where you want to sell the successes, remember a success can be a failure, in a worldly sensibility if possible.)

Post Lab ReportsDue dates and rubrics will be discussed as

we progress and will change in accordance to each laboratory investigation.

Evaluation may take place as a report, quiz, test, or practicum.