Companies in the life sciences sector must adhere to a strict set of federal standards to ensure the health, safety, and effectiveness of their products. These standards are outlined in FDA Title 21 of the Code of Federal Regulations, also commonly referred to as 21 CFR. The European Union (EU) maintains an equivalent set of standards called EudraLex Vol. 4.
In both the U.S. and the EU, these rules govern the way life sciences and healthcare companies manufacture, test, store, package, label, and sell products such as pharmaceuticals, medical devices, cosmetics, biologics, and food.
The FDA’s role in life sciences compliance
In the EU, the duties of issuance and enforcement are shared between the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA). In the states, 21 CFR rules are issued and enforced by the U.S. Food and Drug Administration (FDA). Under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA is responsible for oversight of all food, drugs, and medical products manufactured and/or sold in the U.S.
In the discussion below, we’ll take a closer look at 21 CFR, the FDA’s role in enforcing its conditions, and the benefits of using a Computerized Maintenance Management System (CMMS) to achieve and maintain regulatory compliance across the life sciences industry.
21 CFR and life sciences companies
Life sciences companies such as medical device manufacturers, biotechnology firms, and pharmaceutical companies are required by law to adhere to the conditions delineated by 21 CFR.
These conditions are strict for a reason. Holding life sciences companies accountable ensures that medications, vaccines, medical devices, and other healthcare products are safe to use. This underscores the importance of achieving and maintaining 21 CFR compliance.
The standards set out by 21 CFR ensure that these essential life sciences products are both safe and effective. Below, we take a closer look at some of the specific sections of 21 CFR that have direct relevance to life sciences companies.
- Parts 210 and 211—Current Good Manufacturing Practice (cGMP) in Manufacturing, Processing, Packing, or Holding of Drugs–set requirements for the methods, facilities, and controls used to manufacture, process, and package drugs.
- Part 820—Quality System Regulation (QSR) for Medical Devices—sets requirements for the methods, facilities, and controls used to manufacture, package, label, and service medical devices.
- Part 11—Electronic Records and Electronic Signatures—provides guidelines for ensuring digital data integrity through verification of electronic signatures and electronic records.
- Part 312—Investigational New Drug Application (IND)—requires pharmaceutical companies to provide the FDA with an IND detailing a new drug’s composition and manufacturing process before beginning clinical human trials.
- Part 814–Premarket Approval of Medical Devices—requires manufacturers to obtain FDA approval to market new medical devices in the U.S.
How do maintenance teams support 21 CFR compliance?
Maintenance departments play a particularly important role in ensuring 21 CFR compliance. The safety, healthfulness, and efficacy of life sciences products can depend a great deal on the environments in which they are produced, the equipment used to produce them, and the conditions surrounding their upkeep. In short, robust facilities and equipment maintenance are essential to guaranteeing 21 CFR compliance.
Below, we take a closer look at the components of 21 CFR with specific importance to maintenance teams:
- Part 211, as noted above, sets the rules for drug manufacturing, including the following provisions for the upkeep of physical assets:
- Section 211.58—Maintenance and Cleaning—requires effective upkeep of the buildings used to manufacture, process, package, and hold drug products.
- Section 211.67—Equipment Cleaning and Maintenance—codifies maintenance requirements for equipment used to manufacture drug products including routine calibration, inspection, and testing.
- Part 820, as noted above, sets the rules for medical device manufacturing, including the following provisions for upkeep of physical assets:
- Section 820.70–Production and Process Controls–codifies the maintenance responsibilities for the upkeep of equipment used in the production of medical devices, including routine calibration and contamination prevention.
- Section 820.72—Inspection, Measuring, and Test Equipment—sets the requirements for routinely inspecting, testing, and calibrating equipment used in the production of medical devices.
Title 21 CFR Part 11
CFR Part 11, as noted above, concerns the verification of electronic signatures and records. Maintenance operations rely on the effective management of electronic signatures and records for project accountability, maintenance history, and work order management. This is particularly true in the life sciences sector, where the FDA provides strict data management guidelines.
Below, we take a closer look at specific components of The “Electronic Records; Electronic Signatures” provision impacting maintenance activities in the life sciences sector:
- Validation of Systems (11.10(a)) requires companies to ensure the accuracy, reliability, and consistency of their electronic systems.
- Protection of Records (11.10(c)) mandates that electronic records be accurate, readily retrieved, and protected against loss or security breaches.
- Audit Trails (11.10(e)) requires electronic systems to produce secure, computer-generated, time-stamped audit trails.
- Operational System Checks (11.10(g)) dictates that only authorized personnel can access systems, produce electronic signatures, or alter electronic records.
- Training (11.10(k)) requires comprehensive training ensuring that users understand electronic systems and the procedures for their proper usage.
As the conditions above demonstrate, Part 11 compliance is both a regulatory requirement and a framework for the effective maintenance of electronic systems.
How do CMMS platforms simplify and streamline 21 CFR compliance?
21 CFR compliance is especially vital in the life sciences sector. Non-compliance can disrupt your operation, require costly upgrades, and carry serious legal consequences. Falling short of the standards set out in 21 CFR can also place the public at risk and threaten the reputation of your company.
This is why many life sciences companies turn to CMMS platforms like Limble. The right CMMS software can help simplify and streamline the maintenance processes associated with becoming 21 CFR compliant.
Limble’s leading-edge CMMS solution offers a variety of advanced features designed to ensure that life sciences companies achieve and retain 21 CFR compliant status, including:
- Automated record-keeping
- Preventive maintenance scheduling
- Robust asset management tools
- Audit trails
- Secure access controls
- Electronic records validation
- Work order management
- Real-time data and reporting
- Mobile CMMS appaccessibility
These features can be customized to meet your organization’s specific needs and 21 CFR compliance responsibilities. To find out how Limble’s advanced maintenance software can help you become and remain compliant, download our 21 CFR Compliance Toolkit today!
