Laboratory document management is the process of managing and overseeing documents used within a laboratory. Laboratory document management helps ensure that documentation is readily available, properly distributed, and securely stored.
To handle documents, laboratories implement document management and document control. Document management and document control are two different but related aspects of handling documentation in a company. Document control is a part of document management.
Laboratory document control is the systematic process of controlling documentation through its lifecycle. Laboratory document control includes document security, version control, review, approval, and submission of documents.
Laboratories utilize various types of documents and records. Some common types of documents include the quality manual, standard operating procedures (SOPs), and personnel files. Types of records include laboratory test records, training records, and equipment maintenance and calibration records, among others.
Several standards and regulations outline requirements for laboratory documentation, including ISO 15189:2022, ISO/IEC 17025:2017, and 42 CFR Part 493, among others.
Laboratories can implement document management systems to streamline the document management process. Laboratory document management software streamlines the management of documents by providing predefined workflows for processes such as the creation, review, and approval of documents.
SimplerQMS offers QMS software for life science companies, including laboratories, with robust document management capabilities. Book a personalized demo to experience how SimplerQMS can streamline your document management process.
Explore the specific topics covered in this article:
- What Is Laboratory Document Management?
- What Is Laboratory Document Control?
- What Is the Difference Between Document Management and Document Control in the Laboratory?
- Why Is Documentation Important in Laboratories?
- What Are the Types of Laboratory Documents?
- What Are the Types of Laboratory Records?
- What Are the Key Procedures for Laboratory Document Management?
- Which Standards and Regulations Specify Requirements for Laboratory Documents and Records?
- What Are the Overall Requirements for Laboratory Document Management?
- How Does a Laboratory Document Management System Work?
- What Is the Role of Laboratory Document Management Software?
What Is Laboratory Document Management?
Laboratory document management is the process of managing laboratory documentation, from creation to disposal. Laboratory document management focuses on the overall process of storing, managing, and distributing documents.
Laboratory document management is a requirement in several regulations, standards, and guidelines, such as ISO/IEC 17025:2017, ISO 15189:2022, and 42 CFR Part 493, among others.
Effective laboratory document management is critical for maintaining data integrity, traceability, and compliance.
What Is Laboratory Document Control?
Laboratory document control is the systematic process of controlling laboratory documents and records throughout their lifecycle. Document control involves documentation review, approval, tracking, submission, and versioning.
Laboratory document control is important to ensure laboratories use only the most recent version of documents. Laboratory document control ensures everyone follows the most recent procedures and supports compliance with relevant requirements.
What Is the Difference Between Document Management and Document Control in the Laboratory?
The difference between document management and document control in the laboratory lies in their specific focus.
Laboratory document management involves storing, managing, and distributing documentation. Document management ensures employees can easily create, find, and share the latest document version.
Document control in laboratories controls the review, approval, tracking, and versioning of controlled documents. Laboratory document control ensures that only the most recent approved document versions are accessible while outdated ones are archived.
Document management and document control are interconnected and essential for laboratory operations. Controlled documents are managed, but not all managed documents are controlled. Document control is part of document management, and controlled documents cannot exist without document management practices.
Why Is Documentation Important in Laboratories?
Documentation in laboratories is essential for ensuring the accuracy, traceability, and reproducibility of laboratory results. Documentation provides a record of procedures, data, and observations, supporting effective communication, and ensuring compliance.
Proper documentation helps in the identification of nonconformance or deviations and the implementation of corrective and preventive actions. Documentation in laboratories supports companies in demonstrating compliance with relevant requirements, such as ISO/IEC 17025:2017, ISO 15189:2022, and 42 CFR Part 493, among others.
Documentation supports data integrity by preventing errors, facilitating audits, and providing evidence of adherence to SOPs and protocols, thereby enhancing reliability and credibility. Moreover, thorough documentation allows for effective knowledge transfer, continuity of operations, and continuous improvement.
Documentation forms the backbone of a laboratory’s quality system, promoting accountability and fostering a culture of excellence and compliance.
What Are the Types of Laboratory Documents?
A document is a written, printed, or digital file that provides information or instructions. A laboratory document is a written or digital file that outlines procedures, protocols, guidelines, or other information used in laboratory operations.
Below are some examples of types of laboratory documents.
- Quality Manual
- Standard Operating Procedures (SOPs)
- Work Instruction
- Method
- Personnel Files
- Equipment Manual
- Safety Data Sheets (SDS)
- Supplier Qualification
- Proficiency Testing Plan
- Inventory Control Documents
- Certificate of Analysis (CoA)
- Risk Assessment Form
- Sample Submission Form
Quality Manual
A Quality Manual is a document that outlines the quality management system. The quality manual serves as a guide for ensuring consistency and compliance with requirements throughout the laboratory.
Standard Operating Procedures (SOPs)
SOPs are detailed documents that describe step-by-step actions for operations to ensure they are performed consistently and correctly. SOPs help maintain accuracy, reliability, and efficiency in laboratory operations.
Work Instruction
A work instruction is a document that provides precise, detailed instructions on how to perform specific tasks. Work instructions in the laboratory ensure that tasks are completed correctly and consistently, minimizing errors and increasing the reliability of results.
Method
A document that describes how a specific analytical technique is carried out. Methods are similar to work instruction but focused on a particular testing method. Methods are used in laboratories to ensure consistency, accuracy, and reliability in testing and experiments.
Personnel Files
Personnel files are documents that contain information on employees, including their training, qualifications, and performance evaluations. Personnel files are used in the laboratory to manage employees’ competence, ensure compliance with training requirements, and support Human Resource (HR) activities.
Equipment Manual
The equipment manuals are documents that include operating instructions and maintenance guidelines for equipment. Laboratory equipment manuals ensure that equipment is used properly and maintained to prevent failures and ensure reliable performance.
Safety Data Sheets (SDS)
Safety data sheets (SDS) documents provide detailed information on hazardous chemicals, including handling, storage, and emergency procedures. SDSs are essential for ensuring laboratory safety and regulatory compliance when dealing with hazardous materials.
Supplier Qualification
Supplier qualification documents detail the qualification and approval process for suppliers to ensure they meet the quality specifications and relevant requirements. Supplier qualification documents help laboratories ensure that materials and services received from suppliers are trustworthy, compliant with regulatory requirements, and meet the specifications.
Proficiency Testing Plan
A proficiency testing plan is a document that outlines the schedule and procedures for conducting proficiency tests to evaluate the accuracy and reliability of laboratory results. Proficiency testing plans are used to ensure ongoing competence and compliance.
Inventory Control Documents
Inventory control documents track and manage laboratory supplies, reagents, and materials to maintain traceability to suppliers, stock levels, and proper storage. Inventory control documents help track vendors, prevent shortages or overstocking, and ensure the availability of essential materials.
Certificate of Analysis (CoA)
A Certificate of Analysis (CoA) is a document provided by the manufacturer or supplier that certifies the quality and specifications of a product or material based on testing. CoA documents can be used in laboratories to verify that materials comply with required specifications and requirements before they are used in laboratory processes.
Risk Assessment Form
A risk assessment form is a document that identifies and evaluates potential risks associated with processes, procedures, equipment, or materials. Risk assessment forms help laboratories in developing strategies to mitigate risks and ensure safety and compliance.
What Are the Types of Laboratory Records?
A record is a document that provides evidence of activities, decisions, or events. A laboratory record is a document that captures evidence of laboratory activities, procedures, observations, or results.
Below are some examples of types of laboratory records.
- Laboratory Test Records
- Training Records
- Equipment Calibration Records
- Equipment Maintenance Logs
- Equipment Cleaning Records
- Sample Receipt and Log
- Patient Records
- Waste Disposal Records
- Incident Reports
- Audit Reports
- Quality Control (QC) Records
- Environmental Monitoring Records
Laboratory Test Records
Laboratory test records detail the complete data from all tests conducted in the laboratory. Laboratory test records are used to document test results and provide evidence for validation and compliance.
Training Records
Training records are documented proof that an individual has completed the required training for their role. In laboratories, training records help ensure that personnel are qualified to perform specific tasks, which supports compliance with regulatory requirements and maintains the accuracy and reliability of test results.
Equipment Calibration Records
Equipment calibration records provide evidence that equipment has been calibrated according to established standards. In laboratories, equipment calibration records ensure that equipment functions accurately, which is essential for reliable results, regulatory compliance, and maintaining the integrity of scientific data.
Equipment Maintenance Logs
Equipment maintenance logs are records that document all maintenance activities performed on equipment, including preventative maintenance, cleaning, disinfection, and the replacement of parts. Equipment maintenance logs are used in laboratories to help ensure that equipment remains in optimal working condition.
Equipment Cleaning Records
Equipment cleaning records demonstrate the cleaning, disinfection, or sterilization of equipment. In laboratories, equipment cleaning records are used to help prevent contamination and ensure equipment is ready for use.
Sample Receipt and Log
Sample receipts and logs are records that track the receiving, identification, storage conditions, and portions used for test methods of samples submitted for testing. Sample receipts and logs ensure laboratories can track and manage samples from receipt through testing, avoiding sample mix-ups between different patients.
Patient Records
Patient records include patient information, such as demographics, medical history, and test results. Patient records are used in laboratories to maintain a comprehensive file of the patient, ensuring that relevant information is available for performing tests and evaluating test results accurately.
Waste Disposal Records
Waste disposal records demonstrate the disposal of waste, including contaminated biological samples, residual chemicals, gloves, and needles. Waste disposal records help laboratories ensure compliance with waste requirements, identify responsible vendors, and maintain a safe and clean laboratory environment.
Incident Reports
Incident reports are records of accidents, nonconformances, or deviations, such as chemical spills or equipment failures. Incident reports are used in laboratories to analyze non-compliance with procedures, helping identify root causes and implement corrective and preventive actions.
Audit Reports
Audit reports are documents that summarize the findings, observations, and recommendations from an audit. Audit reports are used in laboratories to assess compliance with internal, customer, and regulatory requirements, identify areas for improvement, and ensure that quality management systems are effective.
Quality Control (QC) Records
Quality Control (QC) records are documents that capture the results of quality control tests performed to ensure that laboratory operations comply with specifications and requirements. In laboratories, QC records verify that all tests and procedures are consistently producing accurate and reliable results, helping ensure the validity and integrity of the data generated.
Environmental Monitoring Records
Environmental monitoring records demonstrate data related to environmental conditions, such as temperature, humidity, and contamination levels. Environmental monitoring records help ensure that the laboratory environment is controlled and complies with specifications and relevant requirements.
What Is the Difference Between Documents and Records in the Laboratory?
The difference between documents and records in a laboratory lies in their purpose and need for updates.
Laboratory documents provide updated information about the laboratory and its processes. Laboratory documents need to be regularly updated to ensure they remain accurate, relevant, and compliant with internal, customer, and regulatory requirements.
Laboratory records are proof of actions taken and the results obtained. Laboratory records keep historical data that remains unchanged and are stored for future reference and compliance purposes.
What Are the Key Procedures for Laboratory Document Management?
A procedure is a documented description of a series of actions outlining how a specific task or process should be performed to ensure consistency and compliance with established standards.
Below are examples of laboratory document management procedures, including document distribution, retention, and disposal, along with laboratory document control procedures, such as document versioning, approval, and access. All these individual procedures are part of a comprehensive document and records management procedure.
- Procedure for Document Versioning: A document versioning procedure, part of document control, ensures that every time a document is created, updated, or changed, a new version is created, labeled, and tracked.
- Procedure for Document Access: A document access procedure, part of document control, controls who can view or edit specific documents.
- Procedure for Document Review: A document review procedure, part of document control, outlines how and when documents should be reviewed to ensure they are accurate, relevant, and current.
- Procedure for Document Approval: A document approval procedure, part of document control, details the steps for getting documents formally approved by authorized personnel before they are released and used.
- Procedure for Document Distribution: A document distribution procedure, part of document management, ensures that the most recent version of a document is distributed to the appropriate personnel or departments.
- Procedure for Document Archiving and Storage: A procedure for document archiving and storage, part of document management, details how and where documents are stored.
- Procedure for Document Retention and Disposal: A document retention and disposal procedure, part of document management, outlines the period documents are retained and how they are securely disposed of when no longer needed.
- Procedure for Control of External Documents: A procedure for controlling external documents, part of document management, details the management of documents received from external sources, ensuring they are controlled and integrated into the company’s document management system.
Which Standards and Regulations Specify Requirements for Laboratory Documents and Records?
The requirements for laboratory documents and records are specified by various standards and regulations.
Below is a list of key standards and regulations that specify the requirements for laboratory documentation.
- ISO/IEC 17025:2017 (Requirements for the Competence of Testing and Calibration Laboratories)
- ISO 15189:2022 (Requirements for Quality and Competence of Medical Laboratories)
- ISO 22367:2020 (Application of Risk Management to Medical Laboratories)
- ISO 9001:2015 (Requirements for Quality Management Systems)
- ISO/IEC 17043:2023 (General Requirements for the Competence of Proficiency Testing Providers)
- ISO 35001:2019 (Biorisk Management for Laboratories and Other Related Organizations)
- 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies)
- 29 CFR Part 1910 (Occupational Safety and Health Standards)
- 42 CFR Part 493 (Clinical Laboratory Improvement Amendments (CLIA))
NOTE
Please be aware that the information provided here is for educational purposes only. Companies must always refer to the official information provided by regulatory authorities to ensure compliance.
ISO/IEC 17025:2017
ISO/IEC 17025:2017 is an international standard that specifies the general requirements for the competence of testing and calibration laboratories.
Section 8.2 on document management outlines that laboratories must establish and maintain clear documentation, ensuring access to relevant personnel.
Section 8.3 requires documents to be properly approved, regularly reviewed, updated as needed, and controlled to avoid using outdated versions. Section 8.4 on control of records specifies that laboratories must create, manage, and retain legible records while implementing effective controls for their identification, storage, and retrieval.
ISO 15189:2022
ISO 15189:2022 is an international standard that specifies requirements for the quality and competence of medical laboratories.
Regarding requirements for managing laboratory documents, ISO 15189:2022 outlines in Section 8.2 that laboratories must establish and maintain documented objectives and policies that ensure quality and competence. Documentation must be accessible to relevant personnel.
Section 8.3 requires laboratories to control documents by ensuring they are properly identified, reviewed, updated, and protected and that obsolete documents are managed to prevent misuse.
Section 8.4 on control of records specifies that laboratories must create, retain, and protect records to demonstrate compliance. Records need to be legible, securely stored, and accessible for the required retention period.
ISO 22367:2020
ISO 22367:2020 is an international standard that outlines the application of risk management to medical laboratories.
Regarding requirements for documents and records control, Annex A.2 requires laboratory policies, procedures, work instructions, and other documents related to risk management to be properly controlled. Laboratories to ensure that documents and records are identified, reviewed, and updated and that outdated documents are handled to prevent misuse.
ISO 9001:2015
ISO 9001:2015 is an international standard outlining the requirements for quality management systems.
Section 7.5.3 requires that documented information must be controlled to ensure it remains available and protected from loss or misuse, including detailed guidelines for distribution, access, retrieval, storage, preservation, modification, and disposal.
In addition, any external documents required for the QMS must be properly identified and controlled to serve as evidence of compliance and prevent unintentional changes.
ISO/IEC 17043:2023
ISO/IEC 17043:2023 is an international standard that outlines the general requirements for the competence of proficiency testing providers.
Regarding document management, Section 8.2 requires laboratories to establish and maintain clear documentation, ensuring that all relevant personnel have access.
On the control of documents and records, Section 8.3 specifies documents to be controlled to prevent the use of outdated versions, being properly approved, regularly reviewed, and updated as needed. Section 8.4 outlines that laboratories must create, manage, and retain legible records while implementing effective controls for their identification, storage, and retrieval.
ISO 35001:2019
ISO 35001:2019 is an international standard that specifies biorisk management for laboratories and other related organizations.
Section 7.5.3 covers the control of documented information. Laboratories must ensure that documentation is available, suitable for use, and protected from loss or misuse. The requirements include managing documentation distribution, access, retrieval, storage, preservation, change control, retention, and disposition.
21 CFR Part 58
21 CFR Part 58 is a regulation by the U.S. Food and Drug Administration (FDA) that outlines the Good Laboratory Practice (GLP) for nonclinical laboratory studies.
Regarding laboratory documentation, Subpart J requires laboratories to organize and retain all study-related records in an archive, ensuring controlled and easy access and protection from deterioration.
29 CFR Part 1910
29 CFR Part 1910 is an FDA regulation that outlines the Occupational Safety and Health Administration (OSHA) requirements for workplace safety and health.
Section 1910.1450 specifies requirements to ensure that relevant safety and health information is documented, maintained, and accessible.
Documentation related to hazardous chemicals, including Safety Data Sheets, must be retained for a specified period. Laboratories are required to maintain records of employee training related to hazardous chemicals, indicating the dates of training and the topics covered.
42 CFR Part 493
42 CFR Part 493 is an FDA regulation that specifies the requirements for laboratories to be certified for testing human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
The 42 CFR Part 493 regulation mentions document management and document control activities in several sections. Overall, laboratories must have written policies and procedures for all testing processes. Laboratories are required to document procedures, test results, and quality control activities.
The documentation must be accurate, complete, and readily accessible. Laboratories must retain records related to testing, quality control, and patient results for specified periods.
What Are the Overall Requirements for Laboratory Document Management?
Based on the regulations and standards, the overall requirements for laboratory document management are listed below.
- Document and Record Control: Laboratories must implement controls to ensure documentation is properly identified, reviewed, updated, and protected from unauthorized changes or misuse.
- Change Management: Any changes to documents must be managed through a documented process that includes proper review, approval, and communication with relevant personnel.
- Documentation Accessibility: Documents must be easily accessible to authorized personnel to ensure that necessary information is readily available for operations, audits, and inspections.
- Documentation Protection and Storage: Laboratories must ensure documents are securely stored to protect them from loss, damage, or unauthorized access, preserving their integrity.
- Document and Record Archiving: Laboratories must maintain an organized archive for storage and easy retrieval of documents and records, ensuring they remain accessible.
- Records Retention: Records must be retained for specified periods, often defined by standards and regulations, for compliance purposes.
How Does a Laboratory Document Management System Work?
A laboratory document management system is usually a computerized system used to provide a centralized digital platform for managing all laboratory documents.
The system integrates both document management and document control system capabilities to enable the secure creation, review, approval, distribution, access, archiving, and disposal of laboratory documents.
Below are some steps in the workflow of a document management system.
- Document Creation and Upload: Documents are created or uploaded into the system.
- Version Control: The system automatically assigns a unique ID and archives outdated document versions to ensure only the most recent document version is available.
- Access Control: Access to documents is managed through permissions, sites, and user roles, ensuring that only authorized personnel can view or modify specific documents.
- Document Review and Approval: Documents are routed through predefined workflows for review and approval, ensuring the document handling processes comply with relevant requirements.
- Time-Stamped Audit Trails: The system keeps a record of all document activities, including changes and approvals, providing a traceable history file for audit and inspection purposes.
- Document Storage: The system securely stores documents in a centralized digital repository, ensuring they are easy to find and retrieve.
- Retention and Disposal: Documents are retained for specified periods based on applicable requirements and are securely disposed of when no longer needed.
What Is the Role of Laboratory Document Management Software?
Laboratory document management software is a system that organizes, stores and manages laboratory documentation to ensure efficient access, version control, and compliance.
The document management software ensures that the most recent document versions are accessible, preventing errors from using outdated information, streamlining workflows, and improving overall efficiency.
Document management and control are essential parts of the Quality Management System (QMS) software. Laboratory QMS software helps ensure documentation is properly managed, current, and compliant with relevant requirements.
SimplerQMS provides QMS software with robust document control software capabilities. SimplerQMS offers predefined workflows, version control, automated routing, electronic signatures, audit trails, and more, ensuring that documents are controlled and easily accessible.
SimplerQMS provides broad support for all QMS processes, including not only document management but also change control, training management, CAPA management, audit management, supplier management, and equipment management, among others.
SimplerQMS supports compliance with life science requirements related to QMS, including the document management and document control requirements outlined in ISO 9001:2015, ISO 15189:2022, ISO/IEC 17025:2017, FDA 21 CFR Part 58, CLIA, and others.
Discover how SimplerQMS can optimize your document management and streamline all QMS processes. Book a personalized demo and talk with our Quality Solution experts.
