Ensuring Audit Readiness: Key Calibration Records & Audit Trails Inspectors Demand

Wondering how to manage calibration records for audit preparedness? In this article, we’ll explore calibration records requirements for processes, documentation, training, and more, along with common issues and best practices.

What are calibration records and why are they important?

Calibration records are official print or digital documentation of all equipment calibration activities, including the assets you’ve tested, dates, measurements, and the names of calibration technicians or external calibration service providers who performed the latest testing. These records are an essential component of compliance and safety for plants using industrial measuring equipment.

Data integrity is essential to inspection readiness. That means data must be created in real time, clearly linked to a specific team member, accurate, organized, accessible, traceable, and stored indefinitely.

What are the major calibration compliance requirements?

Depending on your specific industry, business, and location(s), you’ll be subject to different regulatory compliance standards. These are the major governing agencies and their relevant calibration standards.

FDA calibration requirements

Plants operating or selling products in the United States must adhere to these Food and Drug Administration regulations of calibration and calibration records:

• ALCOA+ is the FDA’s standard requirements for data integrity in calibration records. It stipulates that data should be:
  • Attributable (clear link between tasks, data, and responsible technicians)
  • Legible (understandable by humans and/or computers and stored for required time periods)
  • Contemporaneous (recorded in real time while tasks are performed)
  • Original (in its initial format or a verified copies)
  • Accurate (truthfully represents task performance).
• Now known as ALCOA+, it includes newly added principles:
  • Complete (no omissions)
  • Consistent (well-organized, chronological)
  • Enduring (stored for the required time period)
  • Available (accessible any time).
  • The next likely addition is Traceability, a European Union Good Manufacturing Practice (GMP) standard requiring clear documentation of data storage conditions and revisions.
• 21 CFR Part 11 regulates electronic signatures and recordkeeping for accuracy in digital documentation, including maintenance and calibration records.
• 21 CFR Part 820 mandates design and quality controls throughout the production cycle of medical devices, including calibration requirements.
• General Principles of Software Validation provides guidance on proper software validation. Calibration records stored in an electronic Quality Management System (QMS), such as a computerized maintenance management system (CMMS), must meet unique digital compliance requirements confirmed through Computer Software Validation (CSV).

EMA and EC calibration requirements

The European Medicines Agency (EMA) and European Commission (EC) set standards for manufacturers of medicines, medical devices, cosmetics, food and drink, and more. Plants operating or selling in the European Union must demonstrate compliance with these regulations:

• Good Manufacturing Practice (GMP) is the EU standard for quality processes and controls in manufacturing. EudraLex Annex 11 Volume 4 outlines all plant, equipment, process, and documentation standards, including GMP calibration documentation requirements.
• EU MDR and EU IVDR are regulations specific to the medical device industry and in vitro devices, respectively.

ISO calibration compliance requirements

The International Organization for Standardization (ISO) establishes global compliance standards for high-compliance industries including health, transportation, energy, engineering, and more.

• ISO 9001 regulates standards for measurement traceability, including calibration documentation, across organizations in any sector and of any size. It requires measuring equipment calibration (and documentation of calibration) prior to use and at specified intervals throughout the asset’s lifespan. The exact intervals depend on your national and international standards.
• ISO 13485 is specific to medical device designers, manufacturers, and installers but outlines similar requirements to ISO 9001. It also establishes controls for recordkeeping, electronic signatures, corrective actions, and internal audits.
• ISO 17025, also known as ISO/IEC 17025, is a joint standard developed in conjunction with the International Electrotechnical Commission (IEC). With compliant ISO 17025 calibration records, testing and calibration laboratories can ensure accurate and reliable results that are traceable against international measurement standards.

ISPE GAMP®

The International Society for Pharmaceutical Engineering (ISPE) released guidance for pharmaceutical organizations to create and maintain compliant computer systems.

While it’s not a regulatory standard, the Good Automated Manufacturing Practice (GAMP) guide and supplementary resources support calibration compliance with helpful content about compliant electronic recordkeeping.

What inspectors look for: 8 common challenges with calibration records requirements

With so many diverse regulatory requirements, what do inspectors actually look for when assessing your calibration records and audit trails?

If they discover any of the following issues, you may face noncompliance penalties.

1. Unclear, incomplete, or absent calibration records: You must keep original, legible, attributable, official records of all calibration tasks performed. Teams should regularly back up electronic records, keep them accessible, and organize them for simple filtering by technician, calibration device, the piece of equipment calibrated, calibration dates, and more. You must retain comprehensive calibration records based on national standards and international standards. For example, FDA regulations for the medical device industry stipulate a minimum of 5 years.
2. Undocumented, absent, or excessive changes to records or processes: Changes to all data, processes, and records must be purposeful, uniform, and well-documented. When correcting errors, an authorized team member must thoroughly review, re-sign, and list the reason for changes to documentation. Failure to correct errors, document changes, or re-sign records after any changes compromises the integrity of your data, as do excessive corrective actions.
3. Insufficient or unsubstantiated calibration process documentation: Calibration tasks are vital to your plant’s operational efficiency and safety. That includes the purposeful creation of, documentation of, and adherence to effective standardized operating procedures (SOPs). You must clearly outline all calibration procedures and other measurement processes. Your QMS should promote established procedures for all tasks.
4. Unqualified team members and/or insufficient documentation of roles and responsibilities: Inspectors assess team size, experience, and qualifications (including certifications) by reviewing employee records, org charts, and documentation of all roles and responsibilities. Calibration tasks performed or recorded by unqualified individuals don’t meet compliance requirements.
5. Insufficient training: Both new and existing personnel should receive adequate training. You must clearly document the contents of all training programs, including skills and curriculum, training dates, and attendees. Also, to ensure your calibration training generates results, department heads must conduct internal audits of training curriculum.
6. Improper tool and equipment maintenance: Improperly maintained calibration devices can lead to improperly calibrated equipment, which may increase downtime, put staff in harm’s way, and produce ineffective or dangerous products. Compliance requires regular cleaning, calibration, and other maintenance tasks, including complete and attributable documentation. Do not rely on auto-calibration features alone; you must calibrate equipment with auto-calibration features, too.
7. Failure to conduct internal audits: In addition to inspections by regulatory agencies, you must conduct, track, and establish documented procedures for your own internal inspections and audits. Annually (or more frequently), you’ll assess your overall plant facilities as well as specific equipment, tools, maintenance tasks and processes, training programs, employee certifications, and calibration documentation for inspections. Foregoing internal audits makes you non-compliant.
8. Non-compliant computer systems and calibration management software: FDA 21 CFR Part 11 and EU GMP Annex 11 regulate QMS computer systems and software, assessing their ability to create and secure traceable, accurate records with proper electronic signature controls. Some teams assume that all computer systems are pre-validated, but in reality, you’re responsible for ensuring compliance through Computer Systems Validation (CSV).

For more specifics, review official guidance regarding EMA and FDA regulations and inspections:

• EMA Inspections
• FDA Inspections

Best practices for your calibration audit trail

To prepare for upcoming inspections and audits and avoid non-compliance penalties, follow these best practices.

Clearly define calibration activity roles and responsibilities

Only certified calibration technicians can perform calibration activities. Regulatory compliance standards require that all job descriptions clearly reflect expectations, duties, and qualifications (including certifications).

Document and evaluate calibration processes

Effective calibration processes aren’t enough to stay compliant. Procedures must also be purposeful, easy to follow, and well-documented. You must also regularly inspect and audit processes for maintaining measurement accuracy.

Improve calibration status accessibility

Accessibility is a key element of data integrity, so it should be easy to determine the calibration status of any asset at any time. Link calibration certificates and records with all asset data and implement on-site indicators, such as labels with QR codes, to flag failed calibrations and confirm real-time status in your CMMS.

Automate calibration schedules and alerts

The right software systems help you create reliable, regular calibration schedules with linked work orders and automated reminders. This makes it easier to perform all necessary calibration activities thoroughly and at appropriate calibration intervals.

Integrate calibration tools with maintenance software

Manual recordkeeping is prone to errors and difficult to complete in the field, affecting your ability to keep accurate calibration records with contemporaneous data. By integrating calibration tools and sensors with your maintenance software, you can automatically sync data for real-time, accurate measurements. You can even create work-order triggers for unfavorable calibration results.

Centralize recordkeeping in a CMMS

A computerized maintenance management system (CMMS) can support your regulatory compliance efforts. Collect your calibration and maintenance records in one centralized tool, simplifying electronic audit trail requirements (21 CFR Part 11, for example). Flexible cloud-based solutions let you retain calibration data for any time period required by industry standards — in some cases, 5 years or longer.

How CMMS software supports compliant calibration documentation for inspections

Audit readiness is complex and multi-faceted. While you can outsource calibration services to calibration laboratories, you’re responsible for maintaining compliance (including documented proof of compliance). Validated CMMS software for calibration simplifies audit preparedness.

With eMaint CMMS, you get one centralized tool to:

• Standardize and implement compliant calibration and maintenance processes
• Templatize and automate work orders with your custom SOPs
• Create asset-specific calibration frequency and standards
• View complete calibration history for all measurement equipment and assets, including precise measurements and calibration certificates
• Design and print personalized calibration labels with asset ID, testing dates, calibration notes, and more
• Schedule recurring calibration work orders with a simple drag-and-drop calendar
• Trigger automated alerts and work orders when assets fall out of tolerance, so you can fix existing issues and schedule more frequent calibration as needed
• Link monitoring and measuring equipment to your CMMS for real-time, reliable measurement results
• Route calibration work through all necessary departments, including quality assurance
• Request and validate time-stamped electronic signatures, including new signatures on all changes and updates
• Design custom dashboards to track calibration measurements and trends instantly
• Demonstrate compliance with comprehensive calibration audit trails for national or international standards including ISO/IEC 17025, ISO 9001, 21 CFR Part 11, 21 CFR Part 820, and any other regulations applicable to your industry and plant

Not all teams store calibration records alongside their maintenance records, affecting data availability during audits. Be prepared at a moment’s notice by syncing your calibration programs and data with eMaint CMMS. See for yourself how eMaint can improve your audit readiness — get a free demo.