In the era of laboratory digitalization, the topic of document signatures takes on special significance. Proper security of laboratory documentation, both paper and electronic, is crucial for ensuring data integrity, meeting accreditation requirements, and protecting against unauthorized changes. In this article, we will examine three main categories of signatures used in laboratories: handwritten, digital, and electronic signatures.
đ Handwritten Signatures
âī¸ What is a handwritten signature?
A handwritten signature is a traditional form of document authorization, executed manually by an authorized person using a pen or other writing instrument on a paper medium. In the laboratory context, it is the oldest and still widely used method of confirming document validity.
Application of handwritten signatures in the laboratory
Handwritten signatures are widely used in laboratory documentation, especially in the case of:
Accredited reports
Test reports requiring the personal signature of the laboratory manager or authorized person according to the scope of accreditation.
Internal documentation
Laboratory notebooks, work cards, calibration protocols, where a handwritten signature confirms the execution of activities.
Confidential documents
Confidentiality agreements, internal audit protocols, documentation relating to data security.
Official correspondence
Official letters, responses to complaints, official statements from laboratory management.
Limitations of handwritten signatures
Main challenges associated with handwritten signatures:
- Require physical presence of the signer
- Delay document circulation, especially in distributed locations
- Difficulty in verifying authenticity over time
- Inability to sign documents remotely
- Necessity of storing paper documents
- Exposure to damage or loss of the original
Best practices for using handwritten signatures
To ensure maximum effectiveness and compliance with ISO 17025 requirements, laboratories should follow these principles:
- Unambiguous identification: The signature should be legible or accompanied by an initialed stamp enabling identification of the signer.
- Signature date: Each handwritten signature must be accompanied by the date of its execution, allowing full temporal identification.
- Signature register: The laboratory should maintain a reference register of signatures of persons authorized to approve documents.
- Protection against forgery: Using pens with permanent, waterproof ink that make it impossible to easily remove the signature.
đģ Digital Signatures
đą What is a digital signature?
A digital signature is a graphical representation of a handwritten signature, executed on an electronic device. It can be made using a computer mouse, stylus on a graphics tablet, or finger on a mobile device touchscreen. It is often executed directly on a PDF document.
Digital signature technologies
Mouse signature
The simplest solution, involving "drawing" a signature using a computer mouse. Low precision, but universally available.
Graphics tablet
Professional device with a stylus providing high precision and a natural writing feel, similar to a handwritten signature.
Mobile devices
Smartphones and tablets with touchscreens enabling signature execution with a finger or dedicated stylus (e.g., Apple Pencil).
Online platforms
Internet services such as Adobe Sign, DocuSign, enabling remote signing of PDF documents through a browser.
Application of digital signatures
Digital signatures are used in the laboratory in the following areas:
Important legal disclaimer:
A digital signature (graphical representation of a signature) is not equivalent to an electronic signature in the legal sense. It does not provide cryptographic document security or unambiguous verification of the signer's identity. For this reason, it cannot be used for documents requiring full legal force, such as accredited test protocols or official reports for external clients.
Advantages and limitations of digital signatures
| Aspect | Advantages | Limitations |
|---|---|---|
| Convenience | â Quick signing of PDF documents | â Requires appropriate equipment (tablet, stylus) |
| Security | â PDF can be password-protected | â Lack of cryptographic verification |
| Legal force | â Sufficient for internal documents | â Insufficient for accredited documents |
| Costs | â Low (free PDF software) | â Cost of devices (graphics tablets) |
đ Electronic Signatures
đ What is an electronic signature?
An electronic signature is data in electronic form that is attached to or logically associated with other electronic data and serves as a method of identifying the signer. Unlike a digital signature, an electronic signature uses advanced cryptographic algorithms ensuring authenticity, integrity, and non-repudiation of the document.
Types of electronic signatures
According to the eIDAS regulation (Electronic Identification, Authentication and trust Services), we distinguish three levels of electronic signatures:
Simple electronic signature
Basic form of signature based on hash algorithms (e.g., SHA-256). Provides basic document integrity but does not guarantee identity verification.
Advanced electronic signature
Signature uniquely linked to the signer, enabling their identification and detection of any changes in the signed data.
Qualified electronic signature
Highest level of security. Signature executed using a qualified certificate issued by a qualified trust service provider. Legally equivalent to a handwritten signature.
Qualified signature in the laboratory
The qualified signature is the gold standard for laboratory documentation requiring full legal force. It is particularly important in the context of:
How to obtain a qualified signature?
Process of obtaining a qualified signature:
- Choosing a qualified provider: Qualified trust service providers include companies such as DigiCert, GlobalSign, DocuSign, Adobe Sign, and others operating in various countries.
- Identity verification: Personal visit to a verification point or video verification using an identity document.
- Receiving a certificate: The certificate is issued for a period of 1-3 years and can be delivered on a chip card or as a mobile application.
- Installation and activation: A signature on a chip card requires a card reader and installation of appropriate software. A mobile signature works through a dedicated smartphone application.
Methods of applying a qualified signature
Chip card
Traditional method - certificate stored on a smart card. Requires a card reader connected to a computer. High level of physical security.
Mobile signature
Modern solution - certificate stored in a mobile application. Convenient, does not require additional hardware. Authorization by PIN code or biometrics.
Cloud signature
Certificate stored on secure provider servers. Access from any device through a browser. Multi-factor authentication (SMS, application).
National digital identity apps
Free government applications for citizens (varies by country). Integration with trusted identity profiles. Convenient solution for public administration documents.
Technical aspects of electronic signature
The electronic signature uses asymmetric cryptography based on a key pair:
đ Operating mechanism
- Private key: Known only to the signer, used to create the signature (generating a document hash encrypted with the private key).
- Public key: Publicly available, used to verify the signature (decrypting the hash and comparing it with the original document).
- Hash function: Algorithm (e.g., SHA-256) generating a unique "fingerprint" of the document. Any change in the document causes a change in the hash, immediately revealing manipulation.
- Timestamp: Confirms the exact moment of signature execution, which is crucial for documents of evidentiary significance.
Integration with LIMS system
Modern LIMS (Laboratory Information Management System) systems offer full integration with electronic signatures:
Automatic document workflow
The system automatically routes documents for signature to authorized persons, tracking the status of each authorization stage.
Digital archive
All signed documents are automatically archived with complete change and signature history, ensuring compliance with ISO 17025 requirements.
Signature verification
The system enables instant verification of signature authenticity and document integrity at any time.
Reports and audits
Automatic generation of reports with signature history, necessary during accreditation audits.
đ Comparison of signature types
| Feature | Handwritten signature | Digital signature | Qualified electronic signature |
|---|---|---|---|
| Legal force | â Full | â Limited | â Full (equivalent to handwritten) |
| Authenticity verification | â Difficult, requires expertise | â Lack of cryptographic verification | â Automatic, cryptographic |
| Manipulation detection | â Difficult or impossible | â Limited | â Immediate |
| Remote signing | â Impossible | â Possible online | â Possible via application |
| Document integrity | â No guarantee | â Partial (password-protected PDF) | â Cryptographically guaranteed |
| Implementation costs | â Minimal | â Low | â Medium (certificate, possibly reader) |
| Document circulation speed | â Slow | â Fast | â Very fast |
| Archiving | â Requires space, susceptible to damage | â Digital, secure | â Digital, with long-term verifiability |
| ISO 17025 compliance | â Acceptable | â Insufficient for accredited documents | â Fully compliant |
đ¯ Recommendations for laboratories
Optimal approach to signatures in the laboratory:
- Accredited documents and official reports: Qualified electronic signature or handwritten on paper original.
- Internal reports and quality documentation: Simple electronic signature (hash) in LIMS system with user login.
- Forms and internal procedures: Digital signature (graphical) on PDF files or electronic signature in the system.
- Correspondence and notes: Digital signature or no signature (identification via email address).
- Archive documents: Gradual transition to qualified electronic signatures while preserving old paper documents.
Implementation of electronic signatures - step by step
- Needs analysis: Identify documents requiring different types of signatures in your laboratory.
- Provider selection: Decide which qualified signature provider best suits your needs (chip card vs. mobile signature).
- Procedure update: Adapt laboratory procedures (according to ISO 17025) to new document signing methods.
- Team training: Train all staff in proper execution and verification of electronic signatures.
- LIMS system implementation: Integrate electronic signatures with the laboratory management system for maximum efficiency.
- Monitoring and optimization: Regularly monitor the effectiveness of the new system and introduce improvements.
đŽ Future of signatures in the laboratory
In the coming years, we can expect further evolution of electronic signature technologies. Trends that will shape the future of signatures in laboratories include:
Biometric signatures
Document authorization using fingerprint, facial recognition, or iris scanning, providing the highest level of security.
Blockchain
Distributed ledger technology ensuring immutability and transparency of signature and laboratory document history.
AI and automation
Artificial intelligence supporting signature verification, anomaly detection, and automatic document routing for signature.
International standardization
Harmonization of regulations on electronic signatures at the global level, facilitating international cooperation.
đ Summary
Choosing the appropriate type of signature for different categories of laboratory documents is crucial for ensuring security, regulatory compliance, and process efficiency. Handwritten signatures still have their place in paper documentation, digital signatures work well in internal communication, while qualified electronic signatures represent the future of professional laboratory documentation.
Laboratories striving for full digitalization and compliance with ISO 17025 requirements should consider investing in qualified electronic signatures and their integration with the LIMS system. Such a solution ensures the highest level of security, shortens document circulation time, and significantly reduces operational costs associated with printing and storing paper documentation.
Key conclusions:
- Qualified electronic signature is legally equivalent to a handwritten signature
- Digital signature (graphical) does not provide cryptographic security
- LIMS system with electronic signature integration significantly improves laboratory work
- Implementation of electronic signatures requires appropriate training and procedure updates
- The future belongs to biometric solutions and blockchain-based technology
If you would like to learn more about implementing electronic signatures in your laboratory or need consultation regarding integration with a LIMS system, contact us.