GxP compliance checklist

1. Documentation
2. Equipment
3. Processes and procedures
4. People
5. Environment, health and safety
6. Information security and validation
Requirement Y N
Do we have an existing documentation control system?

Is there a dedicated physical or electronic repository for the storage of live and archived documents?

Does that repository have controlled access?

Is the document repository maintained, monitored and under control by dedicated personnel?

Are all changes to documents audit-trailed, with superseded versions replaced and stored?

Is there a Standard Operating Procedure for the storage, review, retention and archiving of documents?

Do we have a policy/process for guaranteeing the security of all business data and documentation?

Is there an electronic archive/back-up system for business documentation?

Requirement Y N
Do we have a documented process for validating and qualifying the equipment our organisation uses?

Do we have a central equipment and asset inventory, including instruction and operation manuals?

Do we have established, agreed and standardised tolerance limits for equipment and asset health?

Is there a method for continually monitoring that health?

Do we have a documented process for replacing equipment/assets whose health falls outside the agreed
tolerance limits?

Are there documented and visible calibration and maintenance schedules?

Does each maintenance and calibration event have an accompanying log capturing the time/date and
relevant personnel?

Are records of equipment/asset calibration and maintenance securely stored and traceable?
Requirement Y N

Do we have a central listing of all live Standard Operating Procedures (SOPs)?

Are SOPs available in their relevant business locations?

Do we have an overarching SOP governing how other SOPs are drafted, revised, distributed, controlled
and archived?

Is there an SOP review schedule to ensure SOPs remain up-to-date, compliant and fit for purpose?

Is there a change control system should amendments have to be made?

Are deviations from standard procedures fully documented?

Are corrective and preventative actions (CAPAs) fully documented alongside their relevant SOPs?
Requirement Y N
Are all staff properly trained to perform the functions and activities of their roles? Is training associated
with the relevant SOP(s) for that employee?

Does each employee have an associated record of their training, preferably directly accessible by that employee?

Does each employee have a documented training matrix and plan, preferably directly accessible by that
employee?

Do we assess and document the competency of employees on a regular basis?

Do we have an accurate organisational chart?

Do we have a quality function/department within the business?

Can employees quickly and easily raise issues, incidents, concerns and near misses to the quality
department, should they wish to do so?

Are our consultants, contractors, suppliers, vendors and other third parties properly certified, trained and
approved for that function?
Requirement Y N

Is our office, warehouse, manufacturing site and general working facility clean and properly maintained?

Do we have operational environmental controls, and are they regularly audited?

Do all our staff have access to the correct safety equipment and PPE required for their role?

Do we have documented cleaning, sanitation and waste disposal SOPs?

Do we have a properly maintained space for documents, equipment and assets?

Requirement Y N

Are our computer systems password-protected with individual user log-ins?

Do we have a live and visible information security policy?

Are our computer systems regularly backed up to prevent loss of data?

Do we have a continuity plan in place for IT disruption?

Are all computer system changes, maintenance actions, errors and repairs recorded?

If we use software to automate and manage our operation – has that software been fully validated for use?
More GxP resources

1. GxP quality management software

system validation:
quality.eqms.co.uk/blog/gxp
-quality-management-software-syste
m-validation-process

2. Learn how a range of businesses use

EQMS for GxP operation:
qualsys.co.uk/case-studies/

3. Request a custom GxP demonstration

of EQMS here:
quality.eqms.co.uk/eqms-software-de
monstration