Whether required by regulatory agencies or internal policies, a work order approval process establishes accountability in the maintenance process. However, an inefficient or manual approval process unnecessarily extends response times and creates other bottlenecks in daily operations. Electronic signatures streamline the work order approval process, ensuring that maintenance work is completed on time and meets quality standards.
Understanding Electronic Signature Approvals
Electronic signatures are most relevant to organizations regulated by the United Stated Food and Drug Administration (FDA), as they are required to comply with the Code of Federal Regulations (CFR) Title 21 Part 11 standard which sets requirements for electronic recordkeeping and signatures. Other regulatory bodies, such as the International Organization for Standardization (ISO), have similar standards.
21 CFR Part 11 defines an electronic signature as “a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.” According to the standard, electronic signatures must contain the following information:
- The signer’s printed name
- The date and time the signature was applied
- The meaning associated with the signature, such as review, approval, or responsibility
Additionally, electronic signatures must be authenticated to ensure that signees are who they claim to be. Therefore, electronic signatures that are not based upon biometrics require that the signature:
- Contains at least two distinct identification components, such as a username and password
- Is used only by its genuine owner
- Is protected from misuse
Organizations operating in non-regulated industries may have less strict signature requirements.
Learn More: What FDA 21 CFR Part 11 Compliance Means for Maintenance Teams
Ways to Apply Electronic Signatures
Depending on the system, electronic signatures may be applied in multiple ways, including:
- Clicking a button, such as an “Approve” button
- Clicking a “Click to Sign” checkbox
- Selecting an option from a drop-down field
- Typing a name in an input field
- Scanning an image of a handwritten signature
- Using a mouse or stylus to apply a signature in a signature box
- Scanning a fingerprint
- Recording a person’s voice for verbal consent
Note that these methods, in and of themselves, are not sufficient to meet 21 CFR Part 11 requirements.
Learn more about the difference between electronic signatures vs. digital signatures
Benefits of Electronic Signature Approvals for Work Orders
Electronic signatures provide many benefits in the work order approval process.
Reduced Administrative Work
With a paper-based work order approval process, maintenance teams must manually process paperwork, including printing, collecting, organizing, transporting, and archiving work orders. At any point during this process is the possibility of losing or destroying the work order. Electronic signatures allow organizations to go paperless and manage work order approvals from a centralized system.
Unlike handwritten signatures, which present the opportunity for forgery, electronic signatures are usually backed by authentication methods, such as requiring a signer to enter a unique username and password. This ensures that designated approvers are genuinely signing off of maintenance work and are held responsible for the quality and outcomes of repairs. Approvers also hold technicians responsible for ensuring that work orders contain all necessary information and repairs meet quality standards before signing off.
Better Audit Capability
The electronic signature approval process automatically documents the signing process, including when signatures were applied, by whom, and whether changes were required. This provides reliable documentation for internal or regulatory maintenance audits.
The Electronic Signature Approval Process
Electronic signatures streamline the work order approval process, allowing approvers to quickly sign off on completed maintenance work from anywhere they can access the work order. The steps below outline a general work order approval process in a computerized maintenance management system (CMMS) using electronic signatures.
- Work Order Creation: A member of the maintenance team creates a work order using the CMMS. The work order contains details such as the asset in need of maintenance, the required parts and materials, and who should perform the work.
- Notification: The assigned maintenance technician receives a notification informing them about the new work order.
- Access the Work Order: The maintenance technician accesses the work order in the CMMS, using the web-based software or through a CMMS mobile app.
- Work Order Completion: Based on the work order details, the technician performs the work, making sure to record any parts or tools used, complete assigned tasks, log labor hours, and enter any notes relevant to the repair.
- Review and Approval: Before the technician closes the work order, an approver reviews that the work was completed and meets required standards, and that the work order contains all information necessary for closure.
- Electronic Signature Application: When considered complete, the approver applies an electronic signature. Upon electronically signing off on the work order, the CMMS generates a timestamp and logs the approval in the audit trail.
- Work Order Closure: With the work order approved, the work order can be closed. The closed work order is saved into work order history, where it can be referenced later.
CMMS Software and Electronic Signature Compliance
Many maintenance teams use CMMS software to approve work orders using electronic signatures. However, because of the technical, sometimes complex language used in requirements documentation, many organizations believe they are achieving 21 CFR Part 11 compliance when in fact they are not.
One point of misunderstanding comes during the buying process. Buyers will often ask if a vendor’s CMMS is compliant with FDA electronic signature requirements. To be clear, compliance is based on how the CMMS is used by the organization to meet electronic signature requirements, and not the capabilities of the CMMS itself.
Because each CMMS solution handles electronic signatures differently, FDA-regulated organizations should carefully review a solution’s work order approval functionality to understand how it might be used to comply with the 21 CFR Part 11 standard. Some solutions may provide basic electronic signatures, but not go so far as to include components required for FDA electronic signature compliance.
Streamline Work Order Approvals with FTMaintenance Select Electronic Signatures
Electronic signatures bring many advantages to the work order approval process, allowing maintenance teams to reduce administrative work, increase accountability, and create the necessary documentation for audits. FTMaintenance Select is work order management software that allows you to easily manage the work order lifecycle, from initial service request to completion, including work order approvals. Request a demo today to learn more about FTMaintenance Select.