Laboratory Documentation Best Practices
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Laboratory Documentation Best Practices
Laboratory documentation best practices are structured methods for recording, reviewing, updating and retaining information generated during laboratory activities. Good documentation should make records clear, attributable, traceable, accurate and sufficiently complete for another qualified person to understand what was recorded, when it was recorded and, where applicable, who performed or reviewed the activity.
What Are Laboratory Documentation Best Practices?
Laboratory documentation best practices involve creating records that are clear, accurate, contemporaneous, traceable and appropriately controlled.
A strong documentation system connects laboratory activities with the relevant materials, equipment, methods, observations, results and reviews. Records should be created at the appropriate time, contain enough information to reconstruct the activity and be maintained according to the laboratory's applicable quality procedures.
Why Does Laboratory Documentation Matter?
Laboratory records provide evidence of what was performed and what was observed. Without adequate documentation, it may be difficult to reconstruct laboratory activities, understand the origin of a result or determine whether established procedures were followed.
Documentation is therefore an important component of laboratory quality systems. It can support reproducibility, traceability, review, investigation and accountability.
The specific documentation requirements depend on the laboratory's activities, applicable standards, regulations and internal quality system.
| Documentation Function | Why It Matters |
|---|---|
| Traceability | Connects activities and results with relevant materials, samples, equipment and records. |
| Reproducibility | Provides information that can help qualified personnel understand how an activity was performed. |
| Review | Allows laboratory personnel to assess recorded information and identify discrepancies. |
| Accountability | Records can identify who performed, checked or approved an activity where required. |
| Investigation | Historical records can provide useful information when investigating unexpected results or deviations. |
What Makes a Good Laboratory Record?
A useful laboratory record should contain enough information to communicate the relevant activity without requiring unnecessary assumptions.
Depending on the activity, documentation may include dates, times, identifiers, methods, observations, measurements, equipment information, material information and review details.
Clear
Entries should be readable and understandable to the intended users. Ambiguous abbreviations or unexplained terminology can reduce clarity.
Accurate
Measurements, observations and other recorded information should reflect what actually occurred.
Complete
Records should contain the information required by the applicable procedure or quality system.
Traceable
Records should allow relevant materials, samples, equipment, personnel and activities to be connected where appropriate.
Consistent
Using standardized forms, terminology and documentation practices can make records easier to review and compare.
Why Is Contemporaneous Documentation Important?
Contemporaneous documentation means recording information at the time an activity occurs or as close to that time as reasonably appropriate under the applicable procedure.
Recording information promptly helps preserve the sequence of laboratory events and reduces dependence on memory or later reconstruction.
For example, laboratory personnel may record observations, measurements or equipment readings as part of the activity rather than waiting until a later time to recreate the information.
Traceability in Laboratory Documentation
Traceability means being able to connect a laboratory record with the relevant object, material, sample, equipment, activity or result.
For inventory and research materials, this may include linking documentation to lot or batch identifiers. For analytical activities, it may include connecting results to samples, methods, instruments and relevant records.
| Information | Example Traceability Link |
|---|---|
| Material | Material name, manufacturer and applicable lot or batch number. |
| Sample | Unique sample or laboratory identifier. |
| Equipment | Equipment identification or asset number. |
| Activity | Applicable procedure, worksheet or record. |
| Personnel | Identity or documented attribution where required. |
| Result | Connection to the applicable sample, method and supporting records. |
How Should Laboratory Documentation Corrections Be Handled?
Documentation corrections should preserve the original information and make the correction traceable according to the laboratory's applicable procedures.
A correction should not make it impossible for a reviewer to determine what was originally recorded.
For controlled records, the appropriate correction method may depend on whether the record is paper-based or electronic and on the laboratory's quality-system requirements.
Paper Records
Where permitted by the applicable procedure, a correction should remain legible and should identify the corrected information appropriately. The reason for the correction may also need to be documented depending on the record and quality system.
Electronic Records
Electronic systems should use appropriate controls that preserve the history of changes and identify relevant users or actions where required.
Electronic Laboratory Documentation
Electronic records can improve accessibility, organization and searchability, but they also require appropriate controls.
A laboratory using electronic documentation should consider user access, authentication, data integrity, backups, change history, record retention and system validation or qualification requirements where applicable.
| Electronic Record Consideration | Purpose |
|---|---|
| User access | Helps ensure that only appropriately authorized personnel can create or modify records. |
| Audit history | Provides visibility into relevant changes or actions. |
| Backups | Helps protect records against accidental loss or system failure. |
| Record retention | Supports preservation of records for the period required by applicable procedures or requirements. |
| Data security | Helps protect laboratory records from unauthorized access or alteration. |
Laboratory Documentation Review
Documentation review provides an opportunity to identify missing information, inconsistencies, transcription errors or other discrepancies.
The level and timing of review should be defined by the laboratory's applicable procedures.
A reviewer may consider whether the record is complete, whether required fields have been addressed, whether calculations are appropriate and whether relevant identifiers are consistent.
Documentation Review Questions
- Is the record attributable to the appropriate person where required?
- Are relevant dates and times recorded?
- Are material, sample or lot identifiers correct?
- Are required observations and measurements documented?
- Are corrections traceable?
- Are calculations or transcriptions appropriately checked?
- Are required approvals or reviews documented?
- Can the record be understood by an appropriately qualified reviewer?
Common Laboratory Documentation Mistakes
Recording Information From Memory
Delaying documentation can increase the possibility of omissions or inaccurate reconstruction.
Missing Identifiers
A record without sufficient material, sample, lot or equipment identification may be difficult to trace.
Unclear Abbreviations
Unexplained abbreviations can create ambiguity, especially when records are reviewed by personnel who did not create them.
Untraceable Corrections
Corrections that obscure the original information weaken the historical record.
Incomplete Records
Leaving required fields, observations or review information incomplete can make the record difficult to interpret.
Inconsistent Dates or Times
Inconsistent timing information can make it difficult to reconstruct the sequence of laboratory activities.
Uncontrolled Electronic Changes
Electronic records without appropriate access or change controls may create additional data-integrity concerns.
Laboratory Documentation and Lot Tracking
Documentation and inventory management should work together when laboratory materials are managed by lot or batch.
A laboratory may document the material name, lot number, expiration date, receipt date, storage location and relevant supporting records.
This creates a connection between the physical material and its associated documentation.
For materials with defined expiration dates, documentation can also support inventory systems such as FEFO Laboratory Inventory Management, where inventory is prioritized according to expiration date.
Documentation and Storage Records
Storage records are another important part of laboratory documentation. Depending on the laboratory's procedures, records may document storage locations, relevant temperature conditions, monitoring results, excursions and corrective actions.
The objective is to maintain a reliable record of how materials were stored and to make significant deviations visible for appropriate review.
This is particularly important when material specifications or quality requirements depend on defined storage conditions.
Documentation Retention and Organization
Laboratory records should be retained according to the applicable laboratory procedures, regulatory requirements, contracts or quality standards.
Records should remain accessible to authorized personnel for the required retention period while being protected from unauthorized alteration, loss or destruction.
A well-organized documentation system should make it possible to locate relevant records without relying on individual memory or informal filing practices.
Laboratory Documentation Best Practices Checklist
| Best Practice | Check |
|---|---|
| Record information at the appropriate time. | ☐ |
| Use clear and understandable terminology. | ☐ |
| Include required dates and times. | ☐ |
| Record relevant lot, batch or sample identifiers. | ☐ |
| Identify relevant equipment where required. | ☐ |
| Keep corrections traceable. | ☐ |
| Review records according to applicable procedures. | ☐ |
| Protect electronic records with appropriate controls. | ☐ |
| Maintain records for the required retention period. | ☐ |
| Ensure records can be retrieved when needed. | ☐ |
Better Documentation Supports Better Traceability
Clear records connect laboratory activities, materials, samples, equipment and results while providing a stronger foundation for review and quality management.
Explore BacScienceFrequently Asked Questions About Laboratory Documentation
What are laboratory documentation best practices?
Laboratory documentation best practices include creating clear, accurate, complete and traceable records at the appropriate time and maintaining them according to the laboratory's applicable procedures and quality requirements.
Why is laboratory documentation important?
Documentation provides a record of laboratory activities, observations and results. It can support traceability, review, reproducibility, investigations and quality management.
What does contemporaneous documentation mean?
Contemporaneous documentation means recording information when an activity occurs or as close to that time as reasonably appropriate under the applicable procedure.
Should laboratory records include lot numbers?
When lot-level traceability is relevant, recording the applicable lot or batch number can help connect a physical material with its documentation and inventory history.
How should errors in laboratory records be corrected?
Corrections should preserve the original information and remain traceable according to the laboratory's applicable procedures. The appropriate method depends on the type of record and quality system.
Why should laboratory records be attributable?
Attribution helps establish who performed, recorded, reviewed or approved an activity when such identification is required by the applicable procedure.
Are electronic laboratory records reliable?
Electronic records can be reliable when supported by appropriate access controls, data-integrity practices, change histories, backups and record-retention procedures.
How long should laboratory records be retained?
Retention periods depend on the laboratory's procedures, applicable regulations, contracts, standards and the type of record. Laboratories should follow their established retention requirements.
What information should a laboratory record contain?
Depending on the activity, records may include dates, times, personnel attribution, material or sample identifiers, equipment information, methods, observations, measurements, results, corrections and review information.
How does documentation support laboratory traceability?
Documentation can connect materials, lots, samples, equipment, activities and results through consistent identifiers and associated records.
Related Research
- Laboratory Lot Number Documentation
- Laboratory Chain of Custody
- Laboratory Storage Logs
- Laboratory Inventory Management by Lot and Batch
- FEFO Laboratory Inventory Management
- Receiving Laboratory Materials
- Laboratory Vial Label Verification
- Laboratory Vial Inspection
- Laboratory Temperature Excursions
Scientific and Quality References
- International Organization for Standardization. ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories.
- International Organization for Standardization. ISO 15189: Medical laboratories — Requirements for quality and competence.
- U.S. Food and Drug Administration. Guidance and resources concerning laboratory records, data integrity and quality systems.
- World Health Organization. Quality assurance and good documentation practices for laboratory and pharmaceutical environments.