Month: April 2023

Our health and well-being depends on the safety, effectiveness, and security of products we consume and use on our bodies. To protect public health, the United States Food and Drug Administration (FDA) imposes strict oversight on food and beverage, pharmaceutical, and related industries (like medical devices, cosmetics, and tobacco products). The FDA Title 21 CFR Part 11 standard is of special interest to maintenance teams in certain FDA-regulated industries. This article provides an overview of how computerized maintenance management system (CMMS) software can help you achieve compliance with 21 CFR Part 11 requirements.

What is Title 21 CFR Part 11?

The Code of Federal Regulation (CFR) Title 21 lists all federal regulations for organizations operating in the food and drug industry. Of these regulations, the ones most apparent to maintenance teams are Good Manufacturing Practices (GMP) and Title 21 CFR Part 11, which covers requirements for electronic records and electronic signatures.

Why is the 21 CFR Part 11 Standard Necessary?

Traditionally, many maintenance departments relied on manual, paper-based systems to plan and track maintenance work. Like today, the FDA maintained regulations and requirements for these paper records. However, as one can imagine, creating, collecting, storing, and maintaining paper documents requires a lot of time, effort, and physical space. Computerization solved many of these issues.

As computing and digital archiving technology advanced in the 1980s and 1990s, organizations migrated away from manual recordkeeping towards computerized systems. Although the digitization of data made exchanging, searching, and retrieving data easier, the FDA had concerns about the reliability, validity, and authenticity of digital records, compared to paper-based records. Essentially, the FDA felt that digital records were too easy to falsify, which led to the development and implementation of the 21 CFR Part 11 standard in 1997.

21 CFR Part 11 regulations are necessary to protect public health and safety by ensuring that FDA-regulated industries conduct business in a trustworthy, transparent manner. Specifically, this standard sets the criteria for which electronic records and signatures can be accepted as equivalent to their handwritten counterparts of the past. This is especially important today when it is common for bad actors to manipulate and fraudulently modify digital data.

Read Also: A Brief History of CMMS Software

What are 21 CFR Part 11 Requirements?

FDA 21 CFR Part 11 requirements cover two main topics: electronic records and electronic signatures. We provide an overview of these requirements below.

Electronic Recordkeeping

21 CFR Part 11 states that people who create records in a computer system, such as a CMMS, must create procedures and controls to ensure the authenticity, integrity, and confidentiality of electronic records. Electronic records are defined as “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.”

Maintenance teams must do the following to comply with electronic record requirements:

• Validate CMMS software and other recordkeeping systems
• Generate copies of records in human readable and electronic form
• Protect records to enable accuracy and easy retrieval
• Limit system access to authorized users
• Create and maintain an audit trail of changes to maintenance records
• Ensure the system enforces required workflows
• Ensure only authorized users access and use the system
• Verify the identity of users
• Train users to perform assigned tasks
• Document and follow 21 CFR Part 11-compliant policies
• Control distribution of, access to, and use of documentation about the CMMS

Electronic Signatures

The 21 CFR Part 11 standard 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”. Electronic signatures must contain the following information to be considered equivalent to the individual’s handwritten signature:

• The printed name of the signer
• The date and time of the signature
• The meaning associated with the signature, such as review, approval, or responsibility

In addition, electronic signatures are required to be:

• Unique to one individual and not reused or reassigned to anyone else
• Assigned only to an individual whose identity has been verified
• Certified by the signer that the signature is intended to be the legally binding equivalent as their handwritten signature
• Comprised of 2 distinct identifiers, such as a username and password
• Used only by their genuine owner
• Protected from misuse

21 CFR Part 11 also outlines requirements for controlling the security and integrity of usernames and passwords, though they are not covered in this article. Refer to the CFR 21 Part 11 documentation for more information.

CMMS and 21 CFR Part 11 Compliance

Many buyers include FDA compliance as a requirement of their future CMMS system. It is important to note, however, that a CMMS cannot be compliant in and of itself because compliance is related to how the CMMS is used.

A CMMS can help meet 21 CFR Part 11 requirements by providing an electronic system for managing maintenance activities and generating electronic records that are compliant with the regulation. Here are some ways in which a CMMS helps with compliance:

Electronic Records Management

CMMS software allows maintenance departments to manage their tasks electronically, including generating electronic records such as work orders, maintenance schedules, and equipment calibration reports. These electronic records can be managed and stored in compliance with 21 CFR Part 11 requirements, such as maintaining accurate, complete records and ensuring that records are trustworthy and reliable.

Electronic Signatures

A CMMS allows for electronic signatures to be used for approvals and sign-offs, which are necessary for maintenance activities. It can provide the necessary control to ensure compliance with 21 CFR Part 11 requirements, such as being unique to the signer, being secure, and being linked to an electronic record.

Access Controls

CMMS software provides access controls that limit access to electronic records and electronic signatures to authorized personnel only. This helps ensure that only authorized individuals create, modify, or delete electronic records and signatures, and that access to these records is tracked and audited.

Validation

Validating a CMMS ensures that it meets the requirements of 21 CFR Part 11, such as being accurate, reliable, and secure. The validation process ensures that the system is designed and operating in a manner compliant with FDA requirements.

Training

Vendor-provided CMMS training ensures that maintenance employees are able to perform their assigned tasks, demonstrate day-to-day responsibilities to auditors, and generate the documentation necessary to meet 21 CFR Part 11 requirements.

Meet FDA Requirements with FTMaintenance Select

Meeting regulatory requirements is an ongoing challenge given the number of regulations manufacturers must follow, FDA or otherwise. Some organizations may think they are in compliance with 21 CFR Part 11, only to later find out that they are not. FTMaintenance Select helps regulated manufacturers meet FDA requirements by providing a single platform for documenting, tracking, and managing maintenance records and activities. Request your demo of FTMaintenance Select today.

Though computerized maintenance management system (CMMS) software has a relatively short history compared to other business software, it has undergone major change through its life. Learning about the evolution of CMMS from an archaic, manual tracking system to a highly automated, internet-connected maintenance solution certainly gives maintenance professionals a better appreciation for CMMS software. This article provides a brief history of CMMS software.

A Brief History of CMMS

As one might expect, the evolution of computerized maintenance management systems follows the advancement of computers and their related technologies. The sections below look at the history of CMMS as defined by the technology available in different eras throughout the middle 1960’s to today.

The 1960s: Punch Cards

Image derived from: https://www.computerhope.com/jargon/p/punccard.htm

The first CMMS systems are almost unrecognizable by today’s standards. During the 1960’s, maintenance data was recorded using paper punch cards. Maintenance technicians or dedicated keypunch operators would create punch cards to represent work order data.

Punch cards were fed through a card reader hooked up to a mainframe computer, which would translate and store the data. Since each card could only hold a certain amount of information, a stack of cards was often required.

Due to the cost of hardware and operation, punch card-based systems were only of interest to large manufacturing companies that could afford it. In addition, punch cards could do little more than record basic work order information and send out reminders for recurring maintenance work. For many organizations, the return on investment (ROI) wasn’t enough.

The 1970s: Paper-based Maintenance Tracking

As the 1970s approached, maintenance tracking had moved away from punch cards to paper forms. Maintenance technicians would fill out paper work orders manually, and then hand them off to data entry clerks who would submit data to mainframe computers using minicomputer terminals. You may be surprised to learn that even with the modern CMMS systems available, many smaller organizations still operate in a similar fashion.

The 1980s: Adoption of Minicomputers

The use of minicomputers continued to grow into the 1980s. Unlike large, mainframe computers, minicomputers made CMMS more affordable and accessible to medium-sized organizations. CMMS features and functionality become more robust, and the green-screen interface empowered technicians to enter work order data.

The 1990s: Personal Computers and LAN

One of the biggest stages of CMMS evolution coincided with the widespread adoption of personal computers (PCs). No longer were specialists required to enter data through minicomputers – Microsoft Windows-based PCs allowed anyone to effectively use computers using a mouse and graphical user interface (GUI).

At the same time, rapid improvements in processing power, memory, and other technologies gave rise to more sophisticated software programs like spreadsheet and database management software. This enabled organizations to develop custom-built CMMS systems using applications like Microsoft Excel and Microsoft Access. While an improvement over paper-based systems, these homegrown solutions required continuous maintenance and had many limitations.

Further Reading: Pros and Cons of Different Work Order Management Systems

Also, local area networks (LAN) became more prevalent and allowed organizations to link computers together, providing shared access to printers, files, and data. This made maintenance data more accessible across the organization.

During this time, CMMS software was run on site using an organization’s own servers, and required ample IT resources to install, upgrade, troubleshoot, and maintain. Therefore, CMMS was still not feasible for organizations with little-to-no IT infrastructure.

The 2000s: Web-based CMMS

In the 2000s, as the Internet grew and daily use of the World Wide Web became the norm, vendors began to develop web-based CMMS applications. Unlike on-premise software that is run on an organization’s own servers, web-based software is installed and run on servers owned by the vendor. Web-based CMMS also shifted the responsibility of installation, upgrades, security, and data protection to vendors. This is what is referred to as the cloud or cloud computing.

Because web-based solutions greatly lowered the costs of hardware, software, and support service required for implementation, small organizations could finally adopt CMMS technology. The introduction of web-based CMMS also caused larger organizations to re-evaluate their IT infrastructure in order to increase efficiency and better manage upgrades. Many organizations made the switch from on-premise to web-based installations, freeing up their internal IT teams for other projects.

Web-based CMMS also provides the ability for users to access maintenance data from internet connected devices, such as laptops, tablets, and smartphones. This allowed technicians to become more productive by bringing data and the functionality of CMMS out into the field, instead of tethering employees to a home base.

Read Also: How to Choose Mobile Devices for Your Maintenance Team

Today: Connected Devices and the Internet of Things (IoT)

While internet-connected devices have been around for years in a consumer setting, it took many years before industry incorporated “smart” devices into the factory floor. Today, many large organizations leverage what’s known as the Industrial Internet of Things (IIOT), an internet-connected network of sensors, instruments, and applications that gather and share data with one another. This allows for a high degree of automation for failure detection, work order generation, data analysis, and reporting, and forms the basis of a maintenance strategy called predictive maintenance (PdM).

Make the Transition to FTMaintenance Select

Despite the rapid advancement of CMMS software, many organizations still rely on legacy CMMS systems. As organizations look to make maintenance operations more efficient and effective, they must invest in tools that give their maintenance teams the best chance to succeed. FTMaintenance Select is a robust, yet easy-to-use, CMMS platform for documenting, managing, and tracking maintenance activities. Request a demo of FTMaintenance Select today to learn more.