Template-Company
IQ / OQ
Template-SN
Page 4 of 29
Flexar Analytical / FX-10 UHPLC Pumps
IQ/OQ Rev. D June 2009
Protocol Documentation
Documentation protocol may be superseded by customer SOP
Writing Instruments
All writing will be done with a black or blue ink pen.
Signatures
A signature of each party involved with the ownership, management, testing, and quality assurance of each
instrument will be required before testing will proceed and for final approval at completion.
On any page where a written entry is made, or data is gathered by a PerkinElmer representative, that page must
be signed and dated by the PerkinElmer representative.
Up to three signature entries are provided each for Customer and PerkinElmer on the Preliminary Report
Approval Page and Final Approval Page. If any signature lines are unused, draw a single diagonal line filling the
Signature area and then write initials and date next to the line.
All signatures will be the signer’s full legal name as legibly as can be written and dated.
Initials
At any point when initials are to be used, they will contain at least two of the initials and include a date.
Date
Dates will be given in the format of DD-MMM-YYYY. If a month or date is only one digit, a zero will be employed
to maintain the two-digit format for each entry.
Error Codes
When an error is corrected, a single horizontal line through the error will be used. The line will then be initialed
and dated along with an error code from the list found in the protocol.
Spaces
For columns where the protocol is asking whether something has been verified, a “Yes” will be written. If not, a
“No” will be written and an explanation will be stated in the Comments section. A check mark or “N” is
unacceptable. “NA” may be used where the verification was not applicable.
Pass/Fail
For areas where the protocol requires a “Pass/Fail”, the words “Pass” or “Fail” will be written in. If the instrument
passes, Pass will be entered. If the instrument fails, Fail will be entered.
Visual Inspections
All visual inspections will be filled out with a word that indicates the physical condition being observed. If no
damage is observed, use the word “None” if no damage is present. If damage is observed, write a description of
the damage observed. This will apply to any visual inspections.
Calibration/Expiration dates
MM/YY format will be used to denote calibration and reagent expiration dates. The instrument or reagent is valid
until the last day of the month noted.
Temperature
All temperatures will be given in the unit of Celsius (°C)
Blank Areas
If there are no comments for a “Comments” section, “None” is written and the rest of the lines are left blank.
If a section is not applicable, such as an alarm function, “NA” is sufficient
.
