Archive Record Number
Scope of Services Proposed:
Scope of Audit:
What type of vendor is being used?
Manager or Executive in Charge:
Manager or Executive in Charge Phone and E-Mail:
Pathologist Medical Director/Contact
Is the Organization credentialed by any Professional Group?
If so, Describe and Provide copies.
Does the lab use any sub contractor services?
If the lab uses sub contractors: How are they vetted? Who approves them?
If the lab uses sub contractors: Are audit reports issued? May Sponsors view them?
Was a copy of the Lab License obtained? (State, Local, and/or National)
Does Organization have a Mission Statement? Describe.
SOP's Reviewed? Describe.
Were Training Records Reviewed?
Name of Personnel
Title of Personnel
Emergency Management Plan? Describe.
Disaster Recovery Plan Available? Describe.
Blood and Body Fluid Management Program? Describe.
Patient Training and Expectations
CPR Training? Describe.
Organizational chart exists and accurately represents the organization? Decribe.
Is the laboratory affiliated with other organizations? Identify the organizations:
What are the organziations responsibilities in relation to our study? How are they vetted?
Are training records available? List the components of the training record:
Is the CV and job description signed and dated?
Are there personnel curricula (training matrix/plan) established and documented for each individual? Decribe.
Are staff related to the conduct of the study on conformance? Describe.
Does the training program include new hire training and re-qualification training for personnel? Decribe.
Has personnel been appropirately trained to perform functions required by job descriptions? Decribe.
Is there a procedure to assess and document personnel competency on an annual basis? Decribe.
Is there an escalation process by which personnel that do not pass competency on an annual basis? Decribe.
Has the Laboratory manager received GCLP training? If so, by what organization and when?
Has personnel received regulatory training? GCLP? GCP? GLP? Other:
Has personnel received health/safety training? List safety training provided:
Is there a system in place for personnel to report any safety concerns or incidents? Decribe.
Does the laboratory have sufficient qualified personnel to perform function that support the GCLP clinical trial? Decribe.
Is there a list of consultants and is their qualifications maintained? Decribe.
Are external contractors/vendors utilized? If so, are they qualified/approved for use? Is there an SOP that outlines this process?
Is there a Quality Assurance Unit? If so, what are the roles of the Quality Control and the Quality Assurance group and who do they report to?
Does the Quality Assurance Unit perform audits, trend metrics and report the results to the Laboratory Management? Decribe.
What does the QA stuff review? Are they properly trained for the areas they audit?
Is the Quality Assurance Unit independent from the personnel engaged in the direction or conduct of a clinical trial? Decribe.
Does the laboratory maintain any certifications/licenses? Describe.
Does the lab participate in CLIA?
Does the lab participate in CAP?
Does the lab participate in Proficiency Testing?
Does the lab participate in Blinded Sample Analysis?
Was a copy of each current certification obtained?
Does the lab undergo an FDA/state/regional/483 inspection and certification? If so, please indicate what for and the date of the last inspection.
Was a copy of the inspection and certification obtained?
How are lab normals calculated?
Was a copy of the most recent normals obtained?
Is there a governing SOP that outlines the creation, revision, approval, distribution, document control and retirement of SOPs? Decribe.
Are SOPs in compliance with the current version governing SOPs?
Is there a current index listing of the SOPs available? Decribe.
Are there appropriate SOPs in place to conduct the study? If labs utilize guidances in place of SOPs; where are they stored, how are they updated, and who is responsible for them?
Is there a schedule for review of the SOPs and are the SOPs current? Decribe.
Are the SOPs in locations where they are used and does the lab staff have access? Decribe.
Is there a system for documenting and handling SOP/method deviations and CAPAs? Decribe.
Who reviews and approves the documenting and handling SOP/method deviations and CAPAs? How is the Sponsor notified?
Is there a change control system for SOP/Methods? Decribe.
Security and confidentiality is adequate to prevent unauthorized access to records/test samples and a procedure to report unauthorized access exists? Decribe.
Are security staff employees or contracted?
Are there security cameras, window and door alarms?
Is there sufficient space to store materials, archive records, equipment to function properly and conduct laboratory testing? Decribe.
Is the work flow designed to prevent contaminations and mix-ups of test samples? Decribe.
Are storage and processing areas separate? Describe.
Does the lab have a floor plan/facility design?
Is the facility maintained and clean?
Is there safety equipment (e.g. showers, eyewash stations) available? Is the equipment maintained?
Are updated Material Safety Data sheets and Certificate of Analysis available? If so, describe where they are stores and if the labs have access.
Are there environmental controls within laboratory and are the controls monitored? Decribe.
Are personnel wearing appropriate garmenting for designated areas? Decribe.
Is there an SOP detailing the designated routes and methods available for waste disposal? Decribe.
Is the biohazardous and hazardous chemical waste disposal described? Decribe.
Is there sanitation or cleaning procedure establised and is it being followed and documented? Decribe.
Does the Laboratory have a disaster recovery plan that covers all areas for the facility including computer systems and equipment? Describe.
If the Laboratory has a disaster recovery plan, how are changes documented? When is a sponsor notified when the disastor plan is initiated?
Are generators utilized at the facility? Decribe.
Does the lab have an SOP for the testing and maintenance of generators? Request to review generator logs.
Does the lab use a water purifying system? Are there logs to show maintenace of the system? Grade of water utilized?
Is equipment used for GCLP studies readily distinguishable from equipment used for non-GCLP studies? Decribe.
Is there a Master Equipment Inventory present? Decribe.
Are there site-specific SOPs detailing equipment use, maintenance and calibration? Decribe.
Is the equipment utilized in the lab suitable to perform the required operations? Decribe.
Are user logs utilized for equipment/maintence/repair/calibration and do they include a chronological record of use? Decribe.
Log entries show the date, time, name of person performing and checking the work, as appropriate.
Equipment calibration and/or preventative maintenance schedules have been established and are being followed and documented.
Are equipment calibration and/or preventative maintenance schedules listed in an instrument log book?
Records of equipment calibration or maintenance are mainted in the laboratory and archived. Decribe.
Is there a system for moving or removing a piece of equipment from service or tagging the equipment? Documentation? Decribe.
Calibration of the equipment is traceable to NIST or another recognized standards institution. Decribe if the standards have an expiration date. Are they current?
Are there established tolerance limits for the equipment? Who established the tolerance ranges?
Are the equipment manuals available and stored near the instruments? Decribe.
Is there a written equipment qualification/validation program? Decribe.
Are there an assay validation, re-validation and limited validation process outlined in a SOP? Decribe.
What are the criteria for a re-validation?
Is there a written procedure for repeating testing or invalidating lab data? Is there a repeat decision tree? Decribe.
What are the criteria for repeating samples?
Are results that fail specifications investigated or non-conformances investigated? If so, How are they investigated?
Are there validated methods and acceptance criteria for each test method? Decribe.
Is there a SOP for significant figures? Decribe.
Is there a SOP that outlines good documentation practices? Decribe.
Is there an SOP that outlines how reagents are labeled, how expiration dates are established? Decribe.
Are reagents qualified for use? Is parallel testing of the reagents performed? Decribe.
Is there a current inventory of all reagents and solutions? If so, are the reagents viewed in the labs properly labeled? Describe.
Is there a SOP for sample receipt, shipment and storage of materials and test samples? Decribe.
Are storage units monitored for temp/humidity? Validated?
What is the plan when a unit breaks down and how it is documented?
Does the SOP contain a chain of custody procedure? If so, Decribe who retrieves samples from storage and how the removal of samples is tracked.
Is the sample receipt area maintained separate from the sample processing area? Describe.
Are samples stored separately from standards and reference samples?
How are the samples stored? (ie. Box, Bag Rack, etc.)
Is access to computers limited by an individual username and password system (lab members cannot share a user name)? Describe.
Is the computer network and computer systems maintained, if applicable? If so, How is it maintained and who maintains them?
Is there a computer validation master plan and/or SOPs? Describe.
List computer systems and software utilized. Are they validated and are the validation reports available?
Are computer systems validated? Who validates them?
Are changes to computer system errors maintained and investigated? Describe.
Are records of hardware maintenance and repairs maintained? Describe.
Are computers backed up routinely to prevent loss of data?
Is there a back up log for the computer systems?
How often are computers backed up? Where is the backup stored?
Are the systems procted? How is the data retrieved?
Is there a preventative maintenance program for computer systems? Describe program and if it is through an internal source or an external vendor.
Is the LIMS (Laboratory Information Management System) complaint with 21 CFR part 11? Describe.
A documentation control system exists and is functional. Describe.
Is raw laboratory data recorded in lab notebooks, electronically, or controlled data sheets? Describe.
If raw laboratory data is recorded manually, how is the data verified? Who reviews the data?
Are laboratory final reports generated for clinical studies? Who reviews the reports? Describe.
Who prepares and reviews the final reports?
Does the sponsor get to review before finalizing?
How are protocol deviations reported?
When is the sponsor notified?
Who makes the final determination of effect?
Is the a SOP that outlines the content of the final report? Describe.
Is there a SOP tor a system for the retention, storage, and destruction of records? Describe.
Is the sponsor notified prior to destruction of records?
Does the site ensure the sponsor's proprietary information is not disclosed to unauthorized personnel or external organizations? If so, Describe how they ensure it.
Is there a dedicated facility/area for the archival of records? Describe what is archived (ie. Study notebooks, instrument logs, environmental records, etc.).
Is there control access to the archival facility? If so, Describe who has access.
How is the data retrieved from archive?
Is the environment of the facility monitored and controlled? Is there a fire supression system? Describe.
Is the procedure for archiving records outlined in an SOP? Describe.
Is the retention time for records stated in the SOP? If so, Describe how long records are retained on site.
If records are sent off site, where is the off site storeage? How is the data retrieved?
Is there a method of electronic data archive? If so, Describe the format (ie. Cd, DVD, tape, etc.)
List all Deficiencies indentified including classification.
If CAPA is required for this organization, list the CAPA requirements.
Was a close-out conference held? If so, who was present?
Overall Audit Assessment:
Was the organization provided with a copy of AUDIT FORM at the conclusion of the Audit Visit? If so, who received a copy?