Introduction
A laboratory does not operate through equipment and procedures alone.
It also depends on accurate and appropriately controlled documentation and records.
Records provide evidence of what happened, when it happened, who performed an activity and, where applicable, what result or outcome was obtained.
Good documentation supports:
- Traceability
- Quality management
- Equipment management
- Accountability
- Investigations
- Audits
- Regulatory or accreditation requirements
- Continuous improvement
For this reason, documentation and record keeping should be treated as important laboratory skills rather than simply administrative activities.
1. What Is Laboratory Documentation?
Laboratory documentation includes controlled documents that provide instructions, requirements or information needed to perform laboratory activities.
Examples include:
- Policies
- Quality manuals
- Standard Operating Procedures
- Work instructions
- Forms
- Quality procedures
- Equipment procedures
- Manufacturer instructions
- Reference documents
Documents generally describe what should be done.
They should be appropriately reviewed, approved and controlled according to the laboratory’s document-control system.
2. What Are Laboratory Records?
Laboratory records provide evidence that an activity has occurred or that a particular result or observation was obtained.
Examples include:
- Test records
- Equipment logs
- Maintenance records
- Calibration records or certificates
- QC records
- Training records
- Competency records
- Environmental monitoring records
- Incident reports
- Audit records
- Corrective-action records
A simple distinction is:
Documents tell people what to do.
Records provide evidence of what was done.
This distinction is useful when developing a laboratory quality system.
3. Why Is Laboratory Documentation Important?
Good documentation can help answer questions such as:
- Who performed the activity?
- When was it performed?
- Which procedure was followed?
- What equipment was used?
- Was the equipment maintained?
- Was it calibrated or verified where applicable?
- What result was obtained?
- What problems occurred?
- What action was taken?
Without adequate records, answering these questions may become difficult.
Documentation therefore supports both routine laboratory operations and investigations when something goes wrong.
4. Documentation and Laboratory Quality Management
Documentation is an important component of a laboratory quality-management system.
A quality system may contain documents describing:
- Laboratory policies
- Responsibilities
- Procedures
- Equipment management
- Sample handling
- Quality control
- Safety
- Training
- Document control
- Record management
- Corrective action
- Internal audits
The objective is not to create unnecessary paperwork.
The objective is to ensure that important activities are appropriately defined, controlled and supported by reliable records.
5. Laboratory Documentation and Traceability
Traceability involves being able to follow the history, application or location of something through appropriate recorded information.
For example, if an unusual laboratory result is identified, appropriate records may help trace:
Sample → Method → Operator → Equipment → Reagents → QC → Result
Depending on the laboratory, the investigation may also need information about:
- Environmental conditions
- Equipment maintenance
- Calibration or verification
- Sample preparation
- Previous results
- Deviations from procedure
Good traceability makes investigations more systematic.
6. Equipment Records
Laboratory equipment should have appropriate records.
An equipment file or electronic equipment record may contain:
- Equipment name
- Manufacturer
- Model
- Serial number
- Asset number
- Location
- Installation information
- User manual
- Maintenance history
- Calibration records
- Verification records
- Service reports
- Fault history
- Training information
- Decommissioning information where applicable
The exact records required depend on the equipment, its intended use and the laboratory’s quality system.
7. Equipment Identification
Equipment should be identifiable within the laboratory.
Identification may involve:
- Asset numbers
- Equipment identification numbers
- Serial numbers
- Location information
- Status labels
Clear identification helps connect the equipment to its:
- Maintenance records
- Calibration records
- Service reports
- Fault history
- Operating procedures
For example, a calibration certificate is more useful when it can clearly be linked to the specific instrument to which it applies.
8. Laboratory Equipment Maintenance Records
Maintenance records provide evidence of maintenance activities performed on equipment.
A maintenance record may include:
- Equipment identification
- Date
- Maintenance activity
- Person performing the work
- Parts replaced
- Observations
- Functional checks
- Problems identified
- Follow-up actions
- Service-provider information where applicable
Good maintenance records can also help identify recurring equipment problems.
For example, repeated repairs involving the same component may indicate a problem that requires further investigation.
9. Laboratory Calibration Records
Calibration records may include information such as:
- Equipment identification
- Calibration date
- Calibration procedure
- Calibration results
- Reference standards
- Traceability information
- Measurement uncertainty where applicable
- Calibration provider
- Calibration status
- Next calibration date where established
The exact contents depend on the calibration activity and applicable requirements.
Calibration records should be connected to the correct equipment identification so that the laboratory can determine the calibration history of the instrument.
10. Laboratory Test Records
Depending on the laboratory’s activities, test records may include:
- Sample identification
- Date and time
- Method used
- Equipment used
- Reagents or materials
- Operator
- Results
- Relevant observations
- Deviations where applicable
- Quality-control information
The laboratory’s approved procedures should define what information needs to be recorded.
Records should contain enough information to support appropriate interpretation and, where necessary, investigation or review.
11. Sample Traceability
Sample identification and traceability are particularly important in laboratories where samples move through several stages.
A traceability system may need to connect:
Sample → Identification → Receipt → Processing → Testing → Result → Reporting
The exact workflow depends on the laboratory.
Appropriate identification and recording practices help reduce the risk of:
- Sample mix-ups
- Incorrect entries
- Lost samples
- Unclear sample status
- Reporting errors
12. Good Laboratory Documentation Practices
Good records should generally be:
Accurate
Record what actually happened.
Complete
Include information required by the relevant procedure.
Legible
Information should remain readable throughout the required retention period.
Timely
Record information at the appropriate time rather than reconstructing it later from memory.
Traceable
It should be possible to determine who performed or recorded an activity where identification is required.
Consistent
Records should follow established laboratory procedures and formats.
Secure
Records should be protected against inappropriate alteration, loss or unauthorized access.
These principles apply to both paper and electronic records.
13. Recording Information at the Time of Activity
One important documentation principle is to record information as the activity occurs or as close to the activity as the laboratory procedure permits.
Delayed recording can increase the possibility of:
- Forgotten information
- Incorrect times
- Missing observations
- Transcription errors
- Unclear sequence of events
For example, recording an equipment fault immediately provides a more reliable record than attempting to reconstruct the event several days later.
14. Correcting Documentation Errors
Laboratories should have procedures for correcting errors in records.
A correction should preserve the integrity and traceability of the record.
Depending on the applicable system, this may involve:
- Clearly identifying the correction
- Preserving the original entry where required
- Recording the reason for the correction where required
- Identifying who made the correction
- Recording the date of correction
Records should not be altered in a way that makes the original information impossible to determine when the quality system requires preservation of the original entry.
The specific correction method should follow the laboratory’s approved procedure and applicable requirements.
15. Electronic Laboratory Records
Modern laboratories increasingly use electronic systems.
Examples include:
- Laboratory Information Management Systems
- Electronic equipment logs
- Digital quality-management systems
- Instrument software
- Electronic worksheets
- Electronic reporting systems
Electronic records can improve accessibility and traceability, but they also require appropriate controls.
The fact that a record is electronic does not automatically make it reliable.
16. Data Integrity in the Laboratory
Data integrity concerns maintaining data so that it remains reliable, complete and trustworthy throughout its lifecycle.
Important considerations may include:
- Accurate recording
- Appropriate user access
- Traceability of changes
- Protection against unauthorized alteration
- Appropriate backup
- Data retention
- System security
- Reliable transfer of information
Electronic laboratory systems should therefore be managed according to the laboratory’s procedures and applicable requirements.
17. Access Control and Electronic Records
Electronic systems should provide appropriate controls over who can create, modify, approve or access records.
Depending on the system, controls may include:
- Individual user accounts
- Role-based permissions
- Password controls
- Audit trails
- Approval workflows
- Access reviews
- Backup procedures
The appropriate controls depend on the system and the significance of the information being managed.
18. Documentation and Laboratory Equipment Problems
Equipment problems should be documented clearly enough to support troubleshooting and investigation.
For example, instead of writing:
“Machine bad.”
A more useful record might state:
“Instrument displayed error code E-03 during startup at 09:15. Operation was stopped and the equipment was reported according to the laboratory procedure.”
The second record provides information about:
- The equipment condition
- The error indication
- The time
- The action taken
This information can help technical personnel investigate the problem.
19. Documentation of Nonconformities and Incidents
When something does not go according to an established requirement, the event may need to be documented according to the laboratory’s quality procedures.
Examples include:
- Equipment malfunction
- Failed QC
- Incorrect sample identification
- Use of an expired reagent
- Procedure deviation
- Missing record
- Environmental condition outside requirements
A useful record may document:
What happened → When it happened → Who was involved → Immediate action → Investigation → Corrective action where required → Follow-up
The level of documentation should be appropriate to the significance of the event.
20. Document Control
Important laboratory documents should be appropriately controlled.
Document control may include:
- Document identification
- Version numbers
- Approval
- Effective dates
- Review dates
- Authorized distribution
- Access controls
- Withdrawal of obsolete versions
- Retention where required
The objective is to help ensure that personnel use the correct and approved information.
Document control is particularly important for SOPs and other procedures that directly affect laboratory activities.
21. Record Retention
Different types of records may have different retention requirements.
Retention should follow applicable:
- Regulations
- Accreditation requirements
- Laboratory policies
- Contractual requirements
- Organizational procedures
- Quality-management requirements
There is no single retention period that is appropriate for every laboratory record.
The laboratory should establish appropriate retention requirements and ensure records remain accessible for the required period.
22. Storage and Protection of Laboratory Records
Records should be protected against inappropriate:
- Loss
- Damage
- Unauthorized access
- Alteration
- Destruction
For paper records, appropriate storage conditions and access controls may be necessary.
For electronic records, laboratories may need:
- Backups
- Access controls
- Data-recovery procedures
- Appropriate cybersecurity measures
- System maintenance
Record protection should be proportional to the importance and sensitivity of the information.
23. Documentation and Audits
Records are important sources of objective evidence during laboratory audits and reviews.
Auditors may examine records relating to:
- Training
- Equipment
- Maintenance
- Calibration
- QC
- Sample processing
- Documentation
- Corrective action
Good records make it easier to demonstrate that established procedures are being implemented.
Poor records can make it difficult to demonstrate what actually occurred, even when the activity may have been performed correctly.
24. Documentation and Continuous Improvement
Records can provide information that helps laboratories identify opportunities for improvement.
For example, equipment records may reveal:
- Repeated faults
- Increasing maintenance requirements
- Frequent downtime
- Recurring error codes
QC records may reveal:
- Trends
- Shifts
- Increased variability
Training records may reveal:
- Areas requiring refresher training
- Competency gaps
- Repeated procedural problems
In this way, records become a source of information for laboratory improvement rather than simply archived paperwork.
25. Common Laboratory Documentation Mistakes
Laboratories should avoid:
Missing dates
Important activities may become difficult to trace.
Missing identification
It may become unclear who performed an activity where identification is required.
Unclear handwriting
Paper records should remain readable.
Recording information long after the activity
Delayed recording can reduce accuracy.
Using uncontrolled copies
Personnel may follow obsolete information.
Deleting records without authorization
This can compromise traceability and data integrity.
Failing to document equipment faults
Undocumented faults can make troubleshooting and equipment-history review difficult.
Incomplete maintenance records
Missing information can make equipment history difficult to reconstruct.
Poor correction practices
Improper alterations can compromise the integrity of records.
Treating documentation as paperwork only
Records should support actual laboratory activities and quality management.
26. Practical Example: Investigating an Unexpected Laboratory Result
Suppose a laboratory instrument produces an unexpected result.
An investigation may require information about:
- Instrument identification
- Calibration status
- Recent maintenance
- Equipment faults
- QC results
- Operator
- Test method
- Sample preparation
- Reagents
- Environmental conditions
- Previous related results
A well-maintained documentation system allows investigators to reconstruct relevant parts of the process.
Without adequate records, the investigation may become much more difficult.
This demonstrates why documentation is closely connected to laboratory quality and traceability.
27. A Practical Laboratory Record-Keeping Workflow
A simple documentation workflow can be:
Perform → Record → Review → Store → Retrieve → Use for Improvement
Perform
Carry out the laboratory activity according to the approved procedure.
Record
Document required information accurately and at the appropriate time.
Review
Check the record for completeness and obvious errors according to laboratory procedures.
Store
Keep the record in the appropriate controlled location.
Retrieve
Ensure authorized personnel can locate the information when needed.
Use for Improvement
Use relevant records during investigations, audits, equipment reviews and improvement activities.
28. How to Improve Laboratory Documentation
Laboratories can strengthen record keeping by:
- Defining what information must be recorded.
- Using standardized forms and electronic systems where appropriate.
- Training personnel in documentation procedures.
- Controlling laboratory documents.
- Clearly identifying equipment.
- Recording activities at the appropriate time.
- Establishing correction procedures.
- Protecting records from unauthorized changes.
- Establishing appropriate retention requirements.
- Periodically reviewing documentation practices.
- Using records during investigations and audits.
- Improving procedures when recurring documentation problems are identified.
Good documentation should be practical enough that personnel can use it consistently.
29. Frequently Asked Questions
What is laboratory documentation?
Laboratory documentation includes controlled information such as policies, SOPs, work instructions, forms and manuals that describe requirements or instructions for laboratory activities.
What is a laboratory record?
A laboratory record provides evidence that an activity occurred or that a result, observation or decision was recorded.
What is the difference between a document and a record?
A document generally describes what should be done, while a record provides evidence of what was done or what occurred.
Why is laboratory record keeping important?
Record keeping supports traceability, quality management, investigations, audits, accountability, equipment management and continuous improvement.
What should be included in an equipment record?
Depending on the equipment, records may include identification, installation information, maintenance, calibration or verification, service reports, faults and relevant training information.
How long should laboratory records be kept?
Retention periods depend on applicable regulations, accreditation requirements, laboratory policies, contracts and organizational procedures. There is no universal retention period for every laboratory record.
Can laboratory records be corrected?
Yes, when necessary, but corrections should follow the laboratory’s approved procedure and preserve the integrity and traceability of the original information where required.
What is data integrity?
Data integrity refers to maintaining data so that it remains reliable, complete and trustworthy throughout its lifecycle.
Are electronic laboratory records reliable?
Electronic records can be reliable when appropriate controls are implemented for access, changes, security, backup, retention and traceability.
How does documentation support equipment troubleshooting?
Equipment records can provide information about previous faults, maintenance, calibration, service activities and operating conditions, helping technical personnel investigate recurring or unexpected problems.
Conclusion
Documentation and record keeping are essential parts of effective laboratory practice.
Documents provide instructions and requirements, while records provide evidence of activities, observations and results.
When appropriately controlled, laboratory records support:
- Traceability
- Quality management
- Equipment management
- Investigations
- Audits
- Accountability
- Data integrity
- Continuous improvement
Good documentation is therefore more than administrative work.
It is part of professional laboratory practice and an important component of a functioning quality system.
Knowledge Tech Hub Practical Takeaway
Remember:
Documents tell people what to do.
Records provide evidence of what was done.
Traceability connects the records that allow a laboratory to understand what happened.
A practical rule is:
If it matters, document it according to the laboratory’s approved procedure.
Good documentation supports good laboratory practice.
Suggested Internal Links
- [Laboratory Quality Control: A Practical Guide]
- [Laboratory Quality Assurance: Principles, Processes and Best Practices]
- [Laboratory Equipment Maintenance: A Complete Practical Guide]
- [Preventive Maintenance for Laboratory Equipment]
- [Laboratory Equipment Calibration: What Every Laboratory Professional Should Know]
- [Calibration vs Maintenance: Understanding the Difference]
- [Laboratory Standard Operating Procedures (SOPs): A Practical Guide]
- [Common Laboratory Errors and How to Prevent Them]
- [Laboratory Information Management Systems (LIMS): A Beginner’s Guide]
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References and Further Reading
- World Health Organization — Laboratory Quality Management System resources
- ISO 15189 — Medical laboratories — Requirements for quality and competence, where applicable
- ISO/IEC 17025 — General requirements for the competence of testing and calibration laboratories, where applicable
- ISO 9001 — Quality management systems — Requirements
- International Vocabulary of Metrology (VIM)
- Applicable national laboratory regulations
- Applicable accreditation requirements
- Laboratory document-control and record-management procedures
- Laboratory data-integrity procedures
- Manufacturer documentation for laboratory equipment
Note: Laboratories should use the current editions of applicable standards, regulations and accreditation requirements when developing documentation and record-management procedures.
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