Documentation and the Lab Notebook in Biotechnology

Documentation in a lab notebook is an essential skill for any biotechnician. The Food and Drug Administration’s (FDA) handbook states, “if it isn’t written down, it wasn’t done.” Documentation details vary from lab to lab but it is always done for one or all of the following reasons:

  • to record what an individual has done and observed

  • to establish ownership for patent purposes and other legal uses

  • to establish criteria used to evaluate a finished product or the process to make it

  • to trace the manufacture of a product

  • to create a contract between a company and consumers and/or between a company and regulatory agencies

  • to prove that a procedure was done correctly

  • to adhere to, evaluate, and develop standard operating procedures (SOP)

Even good lab work is worthless without documentation, and careful documentation can turn an erroneous result or a failed procedure into a valuable learning experience by providing essential details needed for trouble-shooting. Furthermore, in industry, laboratory notebooks are legal documents. They are used to determine patent rights, product quality, liability, and verify the accuracy of information. Notebooks are treated as if they might be used in a court of law at any time, and you can, in fact, be called upon for questioning about your notebook in court.

An important part of this documentation process is to record what equipment and materials were used, and to show that the equipment and materials were validated and used in the correct manner. Companies must be able to produce documentation for audits by government regulatory agencies to prove that Good Manufacturing Practices (GMPs) were followed. If the material in the notebooks was not entered legibly, or information is missing, companies may 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. The value of a well-kept notebook cannot be overstated.

1. Your lab notebook

In this course, and throughout the Biotechnology program, you will practice good documentation by keeping a lab notebook. Ideally, this is a bound book that does not leave the lab under any circumstances; at some companies, notebooks are even kept under lock and key. However, the logistics of a teaching lab do not allow for such safekeeping. Bring your lab notebook to every lab session in this course. After you complete the course, save your notebook, since it will be part of the portfolio you bring to future job interviews to show prospective employers the quality and scope of your work at ACC.

General rules for writing good lab notebooks are:

  • Write all parts of your lab in ink. Writing with pencil is forbidden in the lab. It’s too easy for unscrupulous people to erase data or errors that they don’t like, at which point important details about their work are lost. If you make an error, draw a single line through it and enter your correction in clear and legible writing. If you discard data for any reason, you must justify your decision to do so immediately and in writing.

  • Write legibly. Remember, supervisors, and possibly lawyers, will be reading your notebook, and if they cannot read your writing, your work is essentially nonexistent. If they cannot easily make out what you have written, they can easily misinterpret an important detail about your work. For example, there is a big difference between “fresh” and “frozen” even though the squiggle for each may look the same.

  • Never cover information in your notebook with anything else or store information on a sheet of paper separate from your notebook. Never fold a page into your notebook. It can easily be lost.

  • If you tape materials such as a graph, a manufacturer’s specification sheet, or instrument readout into your notebook, tape all four sides. Then write “NWUI” (“No writing under insert”) on the tape, your initials, and the date.

  • Keep your records factual, concise, clear and complete in all aspects. Write down important details that have a bearing on your results so that you can answer any questions that might be asked of you about how you did your work.

For this class, your lab notebook should include:

  • A title page with the name of the course, semester and your name.

  • A table of contents with page numbers

  • Lab reports with notes and any appropriate results or other documentation (such as pictures of gel or manufacturers documentation about standards used) — more information on this below

  • Analysis questions for lab (at the end of each lab report)

Each lab report should include three parts:

  1. the pre-lab write-up which is done before you begin the experiment (see below),

  2. the lab notes which includes the standard operating procedure (SOP) used, the data and detailed observations you make while doing the lab, and any other comments you may want to remember or convey to others

  3. the analysis, which is involves any calculations, conclusions drawn, and questions answered after the lab is completed. Most lab exercises come with a set of analysis questions to be answered.

2. Prelab write-up

This must be completed before coming to lab and should include the following:

  • Heading – name of lab, date of lab, name of student

  • A short description of the purpose of the lab

  • Safety information from MSDS (NFPA rating, health hazards and required PPE, spill procedures)

  • Materials and equipment required

  • Detailed list of steps, leaving at least one space between each numbered step

Use your own language, leaving out explanations for each step. Step numbers do not have to correspond to those on the handout but they should be in the same general order. The prelab can either be written into your lab notebook, using good penmanship, or typed, printed, and taped into the lab notebook as described on the previous page. Your instructor may provide you with an electronic copy of the laboratory exercise. In this case, you are required to rewrite the introduction and instructions in YOUR OWN WORDS. This action is required so that the instructor knows that you have acquainted yourself sufficiently with the lab before coming to class (i.e. so you are NOT figuring out what to do while you are trying to do the lab and therefore most likely wasting time and resources). Write only on the left half of the page, and use the right side of the page to record notes and results during lab. Use a ruler to draw a vertical line between the numbered steps and the space for notes and observations. If your prelab is typed, format the document to have two columns, type only in the left column, and cut or fold the page to fit into the left half of the notebook page

The lab handouts include a lot of background material and other information in the procedural steps for your instruction in these techniques. An SOP, however should not include this type of information, and should be limited only to the actual steps taken in a procedure without explanation. You should read the instructions in your manual and extract only the action required of you during lab. This usually reduces a short paragraph to one line or less. Thus, you will create a document that is easier to follow during the lab session, and you will become adept at writing SOPs, a valuable skill in the biotechnology industry.

Composition of SOPs is an art that you must master. It is sometimes difficult to gauge the amount of detail that an SOP needs. An SOP that is too long and detailed is too cumbersome to use routinely, while an SOP lacking sufficient detail will not be lead to uniformity when different people perform the procedures. In this course, we will guide you through these decisions by providing you with a lab protocol to follow. In general, an SOP that needs the most detailed information

  • is used by a large number of people

  • is used infrequently so that the users will not remember exactly how it is done

  • involves especially sensitive or critical steps of a process

For more information on keeping a notebook and writing SOPs, you can find a guide titled “Laboratory Notebooks”, at the Bio-Link website (google Bio-Link). A description on writing an SOP is available in the August 2001 issue of BioPharm, titled “Writing Procedures That Contribute to Performance”, on pp. 22-26. Other examples of SOPs and how to write them successfully can be found through googling “SOP.”

3. During Lab

At the beginning of the lab itself the instructor will check off your pre-lab, much as your supervisor will check off your work in industry. During lab you will take notes in pen as described above. WRITE EVERYTHING DOWN. Yes, we mean everything. How much did you actually weigh out? What are the supplier and the lot number of the reagent? What balance number did you use? What color was your solution? When did it start boiling? How long did each sample take to come off the column? And so on. Be sure to include any changes you made to the procedure in the lab handout, even if they were at the instructor’s direction; always show calculations. In some labs, even the room temperature and humidity is recorded since that can affect the experiment. Writing down everything improves your observational skills, helps you understand the importance of each step, and provides a record of how an experiment might have gone wrong. Each individual should record his or her own notes, even when working in teams.

4. Post-lab

For the post-lab, answer the assigned questions from the lab handout in your lab notebook in complete, grammatically correct sentences. Give as much information as possible to demonstrate your understanding of the concepts. Labs are due the week after the lab is complete. Unless you have an excuse approved by the instructor, late labs will NOT be accepted. Students are allowed to miss only one of the labs during the semester. Make-up labs sessions are provided at the discretion of the instructor and the lab assistant. If there is no make-up lab session available, the student must complete the pre-lab and as much of the post-lab as possible, and will receive a passing grade (70%) on the submitted lab.

5. Lab Competency

Your competency in all the techniques in these lab exercises is the most important outcome of this class. Your ability to perform tasks successfully and use good lab technique will affect your grade. Your instructor will indicate on your graded report whether you have shown competency in these areas. Note that competency is not limited to lab skills, but also includes attendance, punctuality, teamwork, and tidiness.

6. Labeling

Labeling is very important in any lab. It is critical that you label every tube, bottle, flask, cuvette or other container you use in the lab, whatever its contents. This is especially important for any hazardous chemicals or pathogens, but be just as thorough with something as harmless as salt water.

You must label all containers with:

  • the identity of the contents and its concentration

  • your initials

  • the date (and time, if applicable)

  • your class (for example, BITC1311)

  • OR, a number or letter corresponding to a detailed description containing the above information in your lab notebook

If the container is destined to be kept on hand for more than a day, never use a number or letter abbreviation; this will inevitably be found by someone else to whom your symbols mean nothing. Only use the abbreviated labels if you will be disposing of the contents the same day. For example, if you are doing column chromatography, you need only label the collection tubes with numbers in the order that they come off the column. However, if your instructor wants to keep one of your fractions as a control for the next semester’s class, it is imperative that you label the tube with all the information above.

It is not necessary to write the lot number, manufacturer, or other details about the substance on the label, as long as you have recorded that information in your lab notebook. Only the details listed above are necessary for identification.

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