1.

0 PURPOSE
This Standard Operating Procedure (SOP) describes the process for company to
demonstrate calibration and routine preventative maintenance of equipment being used.

2.0 SCOPE
This procedure applies to all trials conducted by Qualified Investigator/Sponsor initiated
research conducted for drugs, natural health products, medical devices, and other trials
involving human participants.

3.0 RESPONSIBILITIES
Management of SOPs for equipment maintenance, as well as program oversight, will vary
by Institution, and will depend on the company structure

Within the SOP or related documents, define the title/position of the individual (delegate)
responsible for the SOP and for any of the following items:
 SOP approval and ongoing review
 •Administration of training on the SOP
 •Oversight of reporting and documentation of equipment maintenance issues
 •Ensuring records retention requirements for equipment maintenance,
 •Oversight of vendors/vendor contracts and agreements if a third party is providing
any services associated with equipment maintenance

4.0 DEFINITIONS
To set a goal for high quality maintenance and calibration.

5.0 PROCEDURE

5.1 Types of Equipment - General Information

5.1.1 Consider the types of research ongoing within an Institution, to ensure that the list of
equipment requiring maintenance and calibration is complete.
5.1.2 The types of equipment that require maintenance and calibration may vary by clinical
trial. Document which equipment will be utilized in the course of the study, including
equipment used while the clinical trial participant is being seen as an inpatient, outpatient,
or equipment for home use.
5.1.3 Depending on the clinical trial, other examples may include, but are not limited to, the
following:
•Investigational Product storage thermometers (e.g., digital thermometer,
temperature/humidity recorders)
 Biological specimen storage thermometers (e.g., digital thermometer)
 •Incubators (e.g., digital thermometer)
 •Blood pressure cuffs: automated and manual
  •Weigh Scales
 •Height Scales
 •Chemotherapy infusion pump
 •ECG machines
 •Spirometers
 •Diagnostic Imaging equipment: MRI, CT, XRAY, Ultrasound, MUGA scan, Bone
Scan, Mammography, Echograms, etc. Centrifuges
 •Polysomnography calibration and certification

5.2 Standard Operating Procedures, Equipment Manuals, and Records

5.2.1 Important Note: If equipment maintenance is the responsibility of another party/group
(e.g., pharmaceutical partner for a study-specific instrument), ensure that this responsibility
is defined in writing (e.g., clinical trial agreement or contract).
5.2.2 Ensure that the equipment maintenance program includes manufacturer’s Operating
Manual(s)(OM), equipment maintenance Standard Operating Procedures (SOPs) used in
the institution where the clinical trial is conducted, and any other related books/documents.
5.2.3 Information in the equipment maintenance records should include (if applicable), but is
not limited to:

 Name of the instrument, including model/serial/identification numbers, etc.,

 •Purpose,
 •Specimen type (if applicable),
 •Operating Manual (OM): A stepwise detailed procedure is required. Anyspecial
precautions to be observed should be clearly indicated, includingsafety
considerations,
 •Service requirements, intervals, and reminders system (reference OM ifpossible),
 •Job descriptions and assignments of personnel involved in operation
andmaintenance,
 •Preventive maintenance records (schedule, procedure, records),
 •Service repair records,
 •Calibration/Testing records (schedule, procedure, records/certificates),
 •Oversight and surveillance of maintenance procedures: Use of Tools such asa
Catalogue of Equipment and a Performance Verification Log are recommended to
ensure that equipment is maintained, as required. This will also facilitate
documentation of oversight and surveillance of this process,
 •Standard Operating Procedure for Equipment Maintenance: SOPs may befiled
individually by log book or centrally at the institution. Define this in the SOP.

Equipment specification – typically this includes the scope or description, background,

operating conditions and environment, list of requirements, warranties, security and training;
 Equipment acceptance testing – application of targeted inspection checks and
testing to determine whether the equipment performs as intended.
5.2.5 Ensure that SOPs include the following:
  Title and/or position of the Individuals involved in writing, amending, and authorizing f
the SOPs. Ensure that SOPs are formally signed/dated by responsible individuals;
 •Filing location of SOP, which may be centrally at the institution, or individually within
each Equipment Maintenance Record;
 •Title and/or position of the Individuals involved in QA/QC testing and the
irresponsibilities including recording;
 •List of equipment to be measured with cross reference to the OM;
 •Schedule/frequency of testing for all equipment listed with cross reference to the
OM;
 •Standardized testing and calibration methods if not described in the OM;
 •Sample of forms, worksheets, charts, and records for testing;
 •Procedures to follow in the event of testing failure or when testing falls outside of
tolerance limits;
 •Schedule of management review of testing reports;
 •Filing location of records generated in the equipment maintenance process.

5.3 Frequency of Equipment Calibration and Maintenance

5.3.1 Refer to the Operating Manual (OM) and SOPs for QA/QC testing frequency.
Generally, minimum of annual calibration is recommended, unless otherwise indicated in
the OM or SOPs.
5.4 Records and Retention
5.4.1 Ensure that the records created as part of the QA/QC program are defined in the
equipment SOPs.
5.4.2 Maintain records in an easily understood format, readily available to all staff, sponsor
representatives, and regulatory authorities. Ensure that the information is completed, up-to-
date, and presented in a form suitable for reviews, as well as external assessments (e.g.,
Health Canada Inspection).
5.4.3 Retain equipment maintenance records for a period of 25 years for studies under a
CTA, and as required for other non-Division 5 studies. Ensure that the records
are retrievable for inspection or other purpose during the entire retention period.
5.4.4 Records may be retained centrally, or by trial. Ensure that local SOPs define the
Institution’s process for retention and retrieval.
5.5 Staff Training
5.5.1 Study/Institution staff: Responsible personnel, other than regular study staff, may also
be part of the Institution, e.g., trained Biomedical Department personnel.
5.5.2 Third party vendor: Execute a contract outlining the agreement for services provided,
with appropriate documentation of credentials and qualifications filed, or available upon
request.
5.5.3 Identify the responsible staff/vendors involved in QA /QC of equipment, including
responsibilities for reporting. Include this information in the SOPs or related documents
(e.g., study delegation log). Ensure that responsible staff/vendors are qualified by education
and training in relation to the equipment requiring assessment/repair.
5.5.4 Ensure that responsible staff/vendors document all of the QA/QC testing,
outcomes/data, and corrective action taken (if required) with results.