Documentation
A. Functions of documentation
1. record
what an individual has done & observed
2. establish
ownership for patent purposes
3. tell
workers how to perform particular tasks
4. establish
the specifications for evaluation
5. demonstrate that a
procedure was performed correctly
6. record operating
parameters of a laboratory instrument
7. ensure
traceability
8. establish contact between
company & consumers and between company & regulatory agencies
B. Types of Documentation
1.
laboratory notebooks
2
Standard
Operating Procedures (SOPs)
3
Forms
4
Protocols
5
Reports
6
equipment/instrument
logbooks
7
recordings from
instruments
8
electronic
documents
9
analytical
laboratory documents
10
numbering systems
11
labels
12
chain of custody
forms
13
training reports
C. Labels
Glass - write on label tape
with black Sharpie, adhere tape to bottle
Microfuge tubes - write on tube with very fine tip Sharpie -
for long term labeling, use a more permanent type of label:
Ex. Computer generate, convert to 6 point font, print out and adhere with
clear tape, overlapping ends.
Ex. Solution
Tris-EDTA Buffer
(10mM Tris-HCl, pH 8, 1 mM EDTA)
Sterile
1/22/09 Team
#
Ex. Sample
Purified E. coli DNA
Conc. 100ng/ml
2/20/09 Team#
D. Laboratory Notebooks
An important legal document
Assigned to individuals - a
chronological log of everything that individual does and observes in the
laboratory.
1. General Rules
·
Record everything
directly into the notebook
·
Always write
legibly with black ink and in English
·
Be so complete
that anyone could exactly duplicate your work
·
Errors should be
marked out with a single horizontal line so that the writing is still visible,
and initialed and dated - in some cases a brief explanation of the correction
should be given
Setting up the Laboratory Notebook:
·
Front of notebook
Name
Date
Project
Company
·
Inside front
cover - summary of notebook keeping rules
·
First pages -
table of contents
Description Page number
·
For each project,
a thorough listing of the results of any literature search and any experimental
information collected from colleagues. (In this class, this will be your 1 page
summary overview of the project we are doing).
·
Record pages
Proceed
consecutively, do not skip any pages
Each
day's entry
First page – Name
“Experiment Title” Date
started
Purpose “The purpose of this experiment is to …”
Procedure – “as described in ‘Biotechnology DNA à Protein’ pp. 52-53 with the following modifications:”
Results-
Conclusions
Answers to questions