Challenges in Laboratory Document and Record Management and How LIMS Can Help

Document and record management in a laboratory involves essential practices for creating, organizing, reviewing, and storing information efficiently.

Proper control of documents and records is not just an administrative matter, but a fundamental pillar for the sound operation of the Quality Management System (QMS).

An effective QMS depends on robust document and record management, since this information is crucial for ensuring the quality and integrity of laboratory processes.

Document and record management can be understood through two core concepts:

• Documents

Documents establish guidelines for carrying out laboratory activities. This includes policies, procedures, and normative instructions that guide operations and are continuously updated as methodology or regulatory requirements evolve.

According to ISO/IEC 17025:2017, documents can be policy statements, procedures, specifications, manufacturer instructions, forms, tables, charts, textbooks, posters, notices, memoranda, drawings, and plans.

• Records

According to ISO/IEC 17025:2017, records are files that provide objective evidence that laboratory activities were carried out in accordance with established procedures and applicable requirements.

Records are the data generated by laboratory activities — objective, permanent captures of information about test execution or the production of results. These records serve as evidence that processes were followed correctly and are essential for maintaining the quality management system.

Unlike documents, records are not updated, but must be kept organized and accessible for audits and traceability.

Records encompass data essential to laboratory traceability and compliance. ISO 17025 establishes strict guidelines for the storage and integrity of laboratory records, requiring accessibility, protection against loss, and preservation of authenticity over time.

The high volume of data and information in the laboratory generates a large quantity of documents and records, and the lack of an adequate control system can lead to significant failures in security, internal communication, and — most critically — compliance with national and international regulations.

Given this scenario, a Laboratory Information Management System (LIMS) emerges as an essential tool for ensuring the efficient management of this information.

Below, I present the main challenges in document and record control for quality management and explore how a LIMS can help.

1. Document Management: Version Control and Integrity

Keeping documents accurate and up to date is one of the main challenges in quality management. As laboratories grow and processes evolve, documents undergo revisions to reflect the latest standards, regulatory requirements, or internal improvements. Without a robust version control system, it becomes easy for outdated documents to circulate or for staff to consult incorrect versions, which can lead to inconsistencies in quality practices.

How a LIMS can help: some LIMS platforms offer robust version control capabilities, ensuring that only the most recent versions of documents are used and that all changes are logged in detailed audit trails. This capability prevents the use of outdated procedures and helps maintain the integrity of laboratory operations.

More modern LIMS platforms, such as Actiz LIMS, offer workflow automation for document-related processes, including review, approval, and change management workflows. Automation not only speeds up these processes but also reduces the likelihood of human error, improving overall workflow efficiency.

2. Accessibility and Retrieval of Documents and Records

In many laboratories, documents and records are stored across multiple locations, whether digital or physical, and accessing them when needed can be a time-consuming process. Delays in retrieving important documents and records can slow down workflows, hinder compliance audits, and prevent quick responses to quality-related issues.

How a LIMS can help: a LIMS enables the centralization of all laboratory documents and records, making them easily accessible to authorized personnel from any location and at any time. This accessibility is particularly critical in environments where quick access to accurate documents and records can significantly impact quality control operations and decision-making.

3. Record Integrity and Preservation

Maintaining the integrity and preservation of records over time is one of the greatest challenges laboratories face. Since records are permanent and cannot be altered, any failure in their management and storage can compromise their authenticity and integrity, undermining process quality and compliance with regulatory requirements.

How a LIMS can help: a modern LIMS, such as Actiz LIMS, provides automated management of laboratory records, ensuring that all data is stored in an organized, immutable manner with full traceability. The system ensures records are properly maintained and accessible over time, with integrity and authenticity preserved, since they cannot be modified without an audit trail logging the change.

4. Compliance with Regulatory Requirements

Laboratories need to ensure their records and documents comply with a range of specific standards and regulations, such as ISO 17025, which requires records to be kept in an organized manner, protected against loss, and accessible — while documents must be accurate, up to date, and aligned with evolving compliance requirements.

Failure to meet these requirements can result in sanctions, audit nonconformities, or even the loss of important certifications. However, ensuring that records and documents meet all regulatory requirements and remain constantly up to date can be a complex process prone to human error.

How a LIMS can help: modern LIMS platforms are designed to ensure laboratory records and documents are stored, managed, and tracked in compliance with regulatory requirements, making audits faster, simpler, and hassle-free.

5. Managing Large Volumes of Records

With growing demand for testing and increasing data output, the volume of records generated by a laboratory can become difficult to control and organize, especially when handled manually. The lack of a systematic approach can lead to lost, duplicated, or poorly organized records, directly impacting the efficiency and quality of laboratory processes.

How a LIMS can help: a LIMS enables the efficient management of large volumes of records by automating data collection and storage. The system can organize records in a structured way, linking them to specific projects, samples, and analyses, which makes searching and management easier. In addition, LIMS automation reduces human error and improves record accuracy, ensuring they remain organized and accessible.

6. Security and Control of Documents and Records

Given the confidential nature of documents and records related to quality control laboratories — such as those detailing processes, test results, or audit findings — it is essential that documents and records be protected against unauthorized access, improper alteration, or loss. Unauthorized access or tampering with documents can compromise the integrity of the quality management system and lead to significant legal and operational risks.

How a LIMS can help: LIMS platforms offer security features that protect sensitive information by controlling user access based on roles and responsibilities. In addition, audit trails for documents and records make it possible to track who accessed, modified, or approved a document at a given time, providing transparency and accountability.

This security is essential for maintaining the confidentiality of critical documents and protecting intellectual property.

More modern LIMS platforms, such as Actiz LIMS, feature multiple layers of protection, including robust encryption, fine-grained access controls, and secure backup systems, all designed to prevent unauthorized access and data breaches.

Conclusion

In the highly regulated laboratory environment, efficient document and record management is just as critical as managing the laboratory processes themselves. The lack of a robust control system can result in significant failures, compromising not only security and internal communication, but, above all, compliance with regulatory requirements.

The era of manual management and paper overload is behind us — today, modern, integrated solutions are essential. While many solutions on the market require separate systems to manage documents and laboratory processes, Actiz LIMS stands out by offering native integration, centralizing all functionality on a single platform. This not only simplifies management but also ensures greater efficiency, regulatory compliance, and a more agile, secure operation.