Pharmaceutical Calibration: Definition, Importance, Process, and Requirements

Calibration is the process of verifying that an instrument or equipment provides accurate and reliable results. In the pharmaceutical industry, calibration involves comparing equipment measurements against a known reference standard to ensure accuracy, supporting product quality, regulatory compliance, and process consistency.

The calibration process applies to manufacturing equipment, analytical instruments, environmental monitoring devices, and temperature-controlled equipment. Pharmaceutical equipment must be calibrated at defined intervals based on factors such as the manufacturer’s recommendation, usage frequency, and the risk associated with measurement drift. Additional calibrations can be triggered by events like repairs, relocation, or inconsistent performance.

The main regulations and guidelines that mandate calibration in the pharmaceutical industry are FDA 21 CFR Part 211, EU GMP, and WHO GMP for finished medicinal products, and ICH Q7 for active pharmaceutical ingredients. These require calibration activities to be performed at defined intervals and to be fully documented.

The pharmaceutical calibration process involves several steps: identifying instruments that require calibration, classifying them by risk and function, defining calibration intervals, and developing standard operating procedures (SOPs). Responsibilities must be assigned, and calibration tasks scheduled proactively. Calibrations are executed according to SOPs using certified, traceable standards, with results recorded, reviewed, and followed by the issuance of calibration certificates and equipment labeling. Out-of-tolerance results prompt investigations and possible corrective actions. Continuous monitoring of the calibration process helps identify trends and optimize calibration frequency and procedures.

An electronic quality management system (eQMS) plays a key role in streamlining the calibration process by linking scheduled calibration activities to automated notifications. An eQMS also ensures secure, centralized storage of calibration records. SimplerQMS is an eQMS designed specifically for life sciences companies, including pharmaceutical manufacturers. SimplerQMS includes a calibration management module and supports compliance with key pharmaceutical requirements such as FDA regulations and EU guidelines.

What Is Calibration In the Pharmaceutical Industry?

Calibration in the pharmaceutical industry ensures that measurement equipment and instruments used in the manufacturing and testing of medicinal products provide accurate and reliable results and readings. Calibration involves a documented comparison of instrument measurements against a certified, traceable standard with known accuracy.

Calibration in the pharmaceutical industry serves three critical purposes: ensuring product quality, meeting regulatory requirements, and supporting process consistency. In pharmaceutical manufacturing, calibration helps maintain accurate process parameters such as mixing speed and temperature. In pharmaceutical quality control (QC) laboratories, calibration ensures analytical equipment such as balances and high-performance liquid chromatographs (HPLCs) produce valid and reliable results. In environmental monitoring, devices that measure humidity, temperature, or pressure are calibrated to maintain controlled conditions and minimize the risk of cross-contamination.

The calibration process applies to both equipment and instruments used during pharmaceutical manufacturing and quality control. It includes establishing reference standards, performing measurements, documenting any deviations, and making necessary corrections to the equipment or instrument under calibration.

Calibration differs from adjustment and verification. Calibration determines measurement accuracy and error but does not alter the instrument or equipment. Adjustment involves modifying the equipment or instrument to bring its readings within specified tolerance limits. Verification confirms whether the equipment or instrument performs within specified limits without making any changes.

Preventive maintenance, on the other hand, involves activities such as cleaning, lubricating, or replacing parts of the equipment to prevent mechanical failures. While preventive maintenance improves equipment reliability and longevity, calibration ensures the accuracy and validity of measurements. Both processes are essential but serve different functions in pharmaceutical operations.

What is the Difference Between Calibration, Qualification and Validation?

The main differences between calibration, qualification, and validation in the pharmaceutical industry lie in their purpose, focus, and frequency. Calibration, qualification, and validation are distinct but interconnected processes that ensure GMP compliance.

Calibration focuses on measurement accuracy and is performed routinely, often daily, monthly, or annually, based on risk, criticality, and frequency of use. For example, a pH meter is calibrated daily using buffer solutions to ensure accurate readings.

Qualification is the documented process of proving that equipment, facilities, or systems are properly installed, operate correctly, and perform consistently within required parameters. Qualification typically consists of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Qualification ensures equipment suitability before use. For instance, an HPLC system must be qualified before it can be used for quality control testing, to confirm that it consistently separates and detects compounds as intended.

Validation is the confirmation that a process, system, or method consistently produces results that meet predetermined specifications. For example, validating a sterilization process ensures that each cycle consistently achieves microbial inactivation. Equipment qualification is a subset of validation. Validation may include software systems, manufacturing processes, cleaning procedures, or analytical methods. The validation process typically involves protocol development, risk assessments, test execution, and report compilation.

The relationship between calibration, qualification, and validation follows a hierarchy. Calibration supports qualification since a qualified instrument must be calibrated. The qualification supports validation by confirming that the equipment used in the validated process functions correctly. A validated sterilization process requires a qualified autoclave, which in turn requires calibrated temperature sensors to ensure accurate control and monitoring.

Why Is Calibration Important in the Pharmaceutical Industry?

Calibration is critical in pharmaceutical operations because product quality and, subsequently, patient safety and regulatory compliance depend on accurate measurements. In the pharmaceutical industry, calibration ensures that the equipment used across manufacturing, quality control, and environmental monitoring consistently produces reliable outputs.

In pharmaceutical manufacturing, calibration confirms that the production equipment operates according to defined, validated, and approved parameters. In the laboratory, calibration ensures test instruments produce valid results for raw materials and finished product testing, as well as stability studies.

Calibration directly supports compliance with Good Manufacturing Practice (GMP) requirements, such as FDA 21 CFR Part 211 and EU GMP. These regulations and guidelines require documented evidence that all equipment and instruments are routinely calibrated using traceable standards. Failure to maintain adequate calibration records in the pharmaceutical industry can trigger significant audit findings and regulatory actions.

The use of uncalibrated or miscalibrated equipment introduces serious risks, such as batch rejection, product recalls, and contamination, if the differential pressures are incorrect in cleanroom environments. These risks compromise product quality and patient safety. Measurement inaccuracies can lead to incorrect test results and undetected critical failures. Such outcomes increase operational costs, delay production, and may lead to regulatory non-compliance and patient impact.

Which Pharmaceutical Instruments and Equipment Require Calibration?

The main equipment and instruments that require calibration in the pharmaceutical industry are listed below.

• Manufacturing and Packaging Process Equipment: Production equipment used during raw materials weighing, blending, or filling must be calibrated to maintain consistency in the manufacturing process and product quality. Examples include mixers used in the granulation process of solid dosage forms and checkweighers in packaging lines.
• Laboratory and Analytical Instruments: Analytical instruments used for testing raw materials, intermediates, and finished products must deliver accurate and reliable results. Instruments such as HPLCs, UV-Vis spectrophotometers, and pH meters fall under this category and require periodic calibration using certified reference standards. pH meters are typically calibrated daily before use, using certified standard buffer solutions that bracket the expected pH range of the samples.
• Temperature-Controlled Equipment: Equipment designed to maintain defined temperature conditions must be calibrated to support stability and storage requirements. Stability chambers, refrigerators, freezers, and incubators are routinely calibrated using reference thermometers placed at predefined locations to ensure they operate within acceptable limits.
• Environmental Monitoring Equipment: Devices monitoring critical environmental conditions in controlled areas must be calibrated to maintain required environmental and contamination control. Instruments like differential pressure gauges, temperature probes, and humidity sensors are essential for detecting changes that could affect product quality. Calibrating pressure gauges is especially critical to prevent cross-contamination between manufacturing rooms.
• Reference Materials: Reference standards used for in-house calibrations must be calibrated and traceable to national or international standards. For example, certified reference weights, which are used for the daily calibration of balances, must be calibrated at predefined intervals.

When Should Pharmaceutical Instruments and Equipment Be Calibrated?

Equipment and instruments used in the pharmaceutical industry must be calibrated at defined intervals based on manufacturer recommendations and frequency of use. The risk associated with measurement drift shall also be assessed to determine the calibration intervals. Calibration frequency is influenced by factors such as the sensitivity of the measurement and operating conditions, such as vibration, humidity, and temperature. Historical performance data can be used to justify tighter or extended calibration intervals through risk-based assessment.

Calibration should be performed during specific lifecycle events, including after installation, following repairs or maintenance, post-relocation, when equipment generates aberrant or inconsistent data, or immediately before performing critical manufacturing or analytical procedures.

Signs that equipment may require calibration, before the next scheduled date, include inconsistent results, visible wear or damage, or after equipment relocation.

GMP regulations and guidelines, such as FDA 21 CFR Part 211 and EU GMP, require the implementation of defined calibration schedules and maintenance of complete, traceable calibration records. GMP requirements mandate that all instruments that may impact the quality, efficacy, or safety of medicinal products must be calibrated using certified, traceable standards at appropriate intervals.

What Are the Regulatory Requirements for Calibration in the Pharmaceutical Industry?

The main regulatory requirements for calibration in the pharmaceutical industry are outlined below.

• 21 CFR Part 211: FDA 21 CFR Part 211 covers GMP for pharmaceutical products marketed in the U.S. Section 211.68 requires calibration of automatic, mechanical, and electronic equipment, while section 211.160 mandates the use of calibrated instruments for testing and recording. The regulation emphasizes the need for an established calibration program, documentation of calibration activities, and remedial actions in case of calibration failure.
• EU GMP: The EU GMP guidelines are applicable to medicinal products marketed in Europe. Chapter 3, for premises and equipment, and Annex 15, for qualification and validation, mandate calibration activities. In clause 3.41 of Chapter 3, it is outlined that equipment used for measuring, weighing, recording, or control must be calibrated at defined intervals using appropriate methods. Calibration records must be maintained. According to clause 3.44, defective equipment must be either removed from production or quality control or clearly labeled to indicate its status.
• WHO GMP: The World Health Organization’s GMP serves as a non-binding global guideline for the manufacturing and testing of pharmaceutical products. Annex 1 for pharmaceutical quality control laboratories and Annex 3 for validation both outline calibration requirements. Section 12 of Annex 1 refers to the calibration of equipment and requires proper labeling to indicate calibration status. Section 15 of Annex 3 for calibration and verification mandates calibration activities during installation qualification of the equipment and afterward at predefined intervals.
• ICH Q7: ICH Q7 contains GMP requirements for active pharmaceutical ingredients. In section 2.22, it is stated that one of the main responsibilities of the quality unit is to ensure that effective systems are in place for maintaining and calibrating critical equipment. Section 5.3 presents the calibration requirements for process and test equipment.
• PIC/S GMP: The Pharmaceutical Inspection Co-operation Scheme aims to harmonize GMP requirements across member countries. PIC/S GMP follows a similar structure to EU-GMP. PIC/S GMP emphasizes structured calibration processes and adequate record-keeping.
• Pharmacopeias (USP and Eur. Ph.): Pharmacopeias provide the legal and scientific basis for quality control during the development, production, and marketing processes. The United States Pharmacopeia (USP) <1058> includes a requirement for documented calibration activities. Both USP and European Pharmacopeia (Eur. Ph.) outline requirements for the calibration of lab instruments used in QC, such as analytical balances.
• GAMP 5: Good Automated Manufacturing Practice is an industry best-practice guide to ensure the quality and compliance of automated systems in the pharmaceutical industry. GAMP recommends a risk-based approach to calibration management and guides the setting up of a calibration management system.
• FDA 21 CFR Part 11 and EU-GMP Annex 11: Calibration records maintained in electronic format must comply with FDA 21 CFR Part 11when medicinal products are supplied in the U.S., and EU-GMP Annex 11 when products are marketed in the EU. Both FDA 21 CFR Part 11 and EU GMP Annex 11 outline specific requirements to ensure data integrity of electronic records.

What Is the Pharmaceutical Calibration Process?

The pharmaceutical calibration process is a structured sequence of steps that ensures all instruments and equipment produce accurate and compliant measurements.

The steps of the calibration process are listed below.

1. Identify Equipment and Instruments Requiring Calibration: List all equipment used in production, packaging, quality control, and monitoring that may impact product quality or process parameters.
2. Classify Equipment Based on Risk and Function: Categorize equipment by its impact on product quality and consistent process execution to prioritize calibration efforts.
3. Define Calibration Intervals: Set frequency based on manufacturer recommendations, equipment usage, historical data, and risk associated with measurement drift.
4. Develop Calibration Procedures: Create SOPs per equipment and instrument type detailing calibration steps, test points, acceptance criteria, required materials, remediation actions, and safety precautions.
5. Assign Responsibilities: Designate trained personnel or qualified external vendors to execute and document calibration activities.
6. Schedule Calibration Activities: Maintain a calibration master plan, as part of the quality system, to ensure timely execution and prevent the use of uncalibrated equipment.
7. Use Certified, Traceable Reference Standards: Employ standards that are traceable to national or international references to ensure accuracy and reliability.
8. Perform Calibration According to SOPs: Execute calibration under controlled conditions, using approved procedures.
9. Document and Review Calibration Results: Record raw data, observations, and any adjustments made in approved forms and review the results for conformance with specifications.
10. Manage Out-of-Tolerance Results: Initiate investigation and impact assessment if readings fall outside acceptable limits and perform corrective actions as needed.
11. Generate and Approve Calibration Certificates: Issue certificates that confirm calibration was performed successfully, including date, technician, results, and standards used.
12. Label Calibrated Equipment: Affix calibration status labels showing calibration date, due date, and equipment identification number to ensure equipment is easily verifiable for use.
13. Store Calibration Records Securely: Maintain electronic or paper records as part of the company’s QMS system to ensure traceability and data integrity.
14. Continuously Monitor the Calibration Process: Review trends and deviations, and audit the calibration program to optimize calibration procedures.

1. Identify Equipment and Instruments Requiring Calibration

The first step in the calibration process in the pharmaceutical industry is to identify all equipment and instruments whose measurements or readings impact product quality, process execution, or regulatory compliance.

All equipment and instruments used in manufacturing, packaging, quality control testing, and environmental monitoring should be registered in an inventory. The equipment should be assessed for its role in controlling critical process parameters, such as weight, temperature, pressure, mixing speed, and time. Equipment used in QC testing or environmental monitoring should also be assessed for its role in generating critical quality data that impacts product release and regulatory compliance.

Examples include balances used in dispensing raw materials, temperature sensors in stability chambers, HPLCs in QC laboratory, and checkweighers in packaging lines. Devices such as pressure gauges monitoring differential pressure must be calibrated due to their role in contamination control. Only equipment with measurement or reading functions influencing quality attributes or compliance status should be subject to calibration.

Identifying which equipment should be calibrated ensures that calibration resources are allocated properly.

2. Classify Equipment Based on Risk and Function

Classifying equipment based on risk and function allows pharmaceutical companies to prioritize calibration activities according to the potential impact on product quality and patient safety. Equipment should be evaluated for criticality, specifically, how a measurement failure would affect product quality, process performance, or regulatory compliance.

Instruments directly controlling critical quality attributes, such as dosage, sterility, or pH, are considered high risk and require stricter calibration control. Devices with an indirect influence or those used for non-critical monitoring may be subject to less frequent or simplified calibration procedures.

A risk-based classification supports efficient use of calibration resources and aligns with ICH Q9 principles for quality risk management and GAMP recommendations for calibration management.

3. Define Calibration Intervals

Defining calibration intervals involves setting timeframes that maintain measurement accuracy while ensuring the efficient use of resources. Calibration intervals must be based on the manufacturer’s recommendation, intended use, frequency of operation, and the criticality of the measurement.

High-risk or high-usage instruments typically require shorter calibration cycles, while low-risk or stable devices may justify extended intervals. Historical calibration performance should also be used to inform appropriate interval selection.

The risk of measurement drift is a key factor in determining calibration frequency. For example, a balance used to weigh raw materials requires frequent calibration, due to the potential impact of weight deviations on finished product formulation. Environmental factors such as vibration, humidity, or frequent relocation also warrant tighter intervals.

A well-documented rationale ensures that intervals are defensible during audits and meet regulatory expectations under GMP.

4. Develop Calibration Procedures

Developing calibration procedures requires creating standard operating procedures tailored to each equipment or instrument type. Each SOP must define calibration steps, measurement points, necessary tools and reference standards, acceptance criteria, environmental conditions, and any safety requirements.

Calibration SOP should also specify the calibration method, absolute or relative. Absolute calibration involves comparing the device directly to a primary standard, while relative calibration checks performance against previously calibrated equipment under similar conditions. In the pharmaceutical industry, following absolute calibration is recommended to meet GMP requirements, as relative calibration does not ensure traceability.

The SOP ensures repeatable and compliant execution of calibration tasks. The inclusion of remediation steps for out-of-tolerance results is critical to maintaining GMP compliance. Clear instructions must define what to do when results fall outside defined limits, such as labeling the equipment out-of-use, performing necessary adjustments, and initiating impact assessments to evaluate potential effects on product quality.

By formalizing calibration through SOPs, pharmaceutical organizations reduce variability, ensure regulatory compliance, and incorporate calibration processes into their QMS. Well-structured procedures support effective training, audit readiness, and consistent control over critical measurement devices.

5. Assign Responsibilities

Assigning responsibilities ensures that only qualified personnel or approved service providers carry out calibration activities. Internal technicians must be trained, assessed for their competency, and authorized to perform calibrations according to established procedures. Alternatively, when calibration is outsourced, external calibration service providers should be accredited to ISO/IEC 17025, which confirms technical competence.

When using third-party providers, supplier qualification must be completed before calibration assignment. The supplier qualification process includes evaluating the service provider’s calibration methods, verifying their certification status and past performance, assessing their quality management system, and auditing their facilities if needed.

The extent of the supplier evaluation activities depends on the requirements set in the SOP for supplier qualification. The suppliers of reference materials used in calibration shall also undergo a qualification process.

6. Schedule Calibration Activities

Scheduling calibration activities requires maintaining a calibration master plan integrated within the pharmaceutical quality system. The calibration plan includes all instruments and equipment requiring calibration, their assigned calibration intervals, due dates, and responsible personnel or approved service providers. The calibration master plan serves as a proactive mechanism to prevent missed or delayed calibrations.

Each calibration task must be assigned to relevant personnel and actively monitored to ensure timely execution. An electronic quality management system can enhance oversight by automating reminders, tracking task completion, and flagging overdue calibrations.

A structured and well-maintained plan ensures calibration is treated as a controlled process, reduces the risk of missed or undocumented calibrations, and supports GMP compliance.

7. Use Certified, Traceable Reference Standards

Using certified, traceable reference standards ensures that calibration results are accurate and compliant with GMP requirements. Standards used in calibration activities must be traceable to national or international standards.

Traceability of standards establishes an unbroken chain of comparisons, each with documented measurement uncertainty, guaranteeing that all measurements align with globally recognized values.

For example, certified reference weights used to calibrate analytical balances must include calibration certificates detailing uncertainty values and traceability data. Using uncertified or expired standards risks invalidating calibration results and introducing undetected measurement errors.

8. Perform Calibration According to SOPs

Performing calibration according to established SOPs ensures consistency, repeatability, and compliance with GMP requirements. Each calibration must be executed under controlled environmental conditions that reflect normal equipment use, using defined methods, approved tools, and certified reference standards.

Both internal technicians and external service providers must follow equivalent documented procedures to ensure uniformity and reliability of calibration activities.

Regardless of who performs the calibration, all results must be documented using approved forms that are integrated into the QMS. This documentation should include raw data, deviations, and any relevant observations.

Procedural consistency safeguards product quality and satisfies regulatory expectations.

9. Document and Review Calibration Results

Documenting and reviewing calibration results ensures traceability of activities and data integrity while verifying measurement accuracy. All calibration data, including raw measurements, environmental conditions, test points, observations, and any adjustments, must be recorded and signed in approved forms.

The documentation must link each calibration to the reference standard used and associated measurement uncertainty and include technician identification, calibration date, final calibration status, and instrument ID.

The review of calibration results confirms whether the instrument meets the defined acceptance criteria. Any deviation or out-of-tolerance results must be investigated by the QA department.

Review and approval of calibration results by authorized personnel not only verifies the calibration results but also confirms that the calibration process was executed correctly.

10. Manage Out-of-Tolerance Results

Managing out-of-tolerance results is critical to maintaining control over product quality and ensuring patient safety. When calibration results fall outside established tolerance limits, a quality investigation must be performed to identify the root cause.

The investigation should include evaluating whether the equipment was used in production or for testing since the last successful calibration date and assessing the potential impact on released batches and any affected processes. The quality investigation shall be performed following the relevant QMS procedure.

Immediate actions should include placing the equipment out-of-use until its calibration status is restored. Corrective actions may include equipment adjustment, recalibration, or repair. 

11. Generate and Approve Calibration Certificates

Generating and approving calibration certificates provides formal evidence that calibrations were performed according to documented procedures and met specified criteria.

Each certificate must include key information, including equipment ID, calibration date, technician name, reference standards used- including traceability information, measurement data, acceptance limits, and final calibration status (pass/fail). The certificate must be reviewed and approved by authorized personnel to verify accuracy and completeness.

Calibration certificates serve as audit-ready documentation and support compliance with GMP record-keeping requirements. Approved certificates ensure that all calibration activities are traceable, verified, and defensible during inspections.

12. Label Calibrated Equipment

Labeling calibrated equipment provides quick visual confirmation of calibration status and prevents the use of uncalibrated equipment. Each label must display the calibration status, calibration date, next due date, and equipment identification number. The calibration label should be affixed in a visible location on the equipment and remain legible throughout the equipment’s use.

Proper labeling supports GMP compliance and operational control. For instance, a balance in a production area must have a calibration label, so operators can immediately verify its validity before using it.

In cases where equipment is not calibrated or is awaiting service, an “out-of-use” label must be applied to prevent unintended operation. Using color-coded labels, such as green for calibrated or red for out-of-use, further enhances visibility.

Consistent and clear labeling minimizes the risk of data integrity issues and supports audit readiness.

13. Store Calibration Records Securely

Storing calibration records securely is essential to ensure traceability, data integrity, and regulatory compliance.

All records, whether paper-based or electronic, must be maintained according to the document retention procedure and protected against unauthorized access, alteration, or loss. Each record must be complete, legible, and easily retrievable during audits.

Electronic storage in validated systems provides enhanced control compared to paper-based systems, offering features such as access logs, audit trails, and backup mechanisms. Secure storage ensures evidence of calibration is preserved throughout the equipment’s lifecycle.

14. Continuously Monitor the Calibration Process

Continuously monitoring the calibration process is essential to ensure its ongoing effectiveness.

Calibration process monitoring includes routine analysis of calibration trends, out-of-tolerance results, recurring deviations, and equipment failure patterns. Analyzing these trends helps identify poorly performing instruments, refine calibration intervals, and improve procedures.

Internal audits can support the monitoring and improvement of the calibration process. Internal audits verify adherence to SOPs, completeness and accuracy of records, proper equipment labeling, and timely execution of scheduled calibration tasks.

Insights gained from audits and trend reviews enable continuous improvement of calibration management.

How Does Calibration Differ in the Pharmaceutical Industry and Medical Device Industry?

Calibration in the pharmaceutical industry differs from calibration in the medical device industry due to the nature of the products, regulatory frameworks, and the types of equipment involved.

Pharmaceutical products typically involve chemical or biological formulations requiring precise control of process parameters such as mixing, pH, and temperature, along with analytical measurements for potency, purity, and content uniformity. Medical devices, on the other hand, often involve mechanical, electrical, or electronic components that must meet strict dimensional tolerances and functional performance specifications. Despite these differences, calibration in both the pharmaceutical and medical device industries serves the same purpose, ensuring measurement accuracy for equipment used in production, quality control, and environmental monitoring.

The pharmaceutical industry operates under GMP requirements, such as FDA 21 CFR Part 210-211 and EU- GMP. In contrast, the medical device industry follows medical device regulations, like EU MDR and FDA 21 CFR Part 820, and international standards such as ISO 13485:2016.

Examples of calibration equipment differ across industries due to operational needs. The pharmaceutical industry relies on analytical instruments like HPLCs for QC testing, process equipment such as automated capsule fillers and tablet presses in production, and environmental monitoring systems, all requiring calibration to support consistent process execution.

Calibration in the medical device industry applies to manufacturing equipment such as temperature controllers on injection molding machines, precision measuring instruments used in assembly processes, and environmental monitoring systems. Calibration may also extend to the medical devices themselves when they function as measurement instruments, such as infusion pumps, blood pressure monitors, or diagnostic analyzers.

Despite these operational differences, both industries demand documented, traceable, and risk-based calibration management systems to ensure compliance and product quality.

What Is the Role of QMS Software in Streamlining Pharmaceutical Calibration Activities?

QMS software is a digital platform used to manage quality-related processes such as document control, change management, training, equipment calibration, and other processes. In the pharmaceutical industry, an electronic QMS helps streamline calibration management by linking planned calibration activities with automatic notifications and reminders, and centralizing documentation to support compliance with GMP requirements.

An eQMS enables efficient management of calibration schedules by tracking due dates and sending automated notifications to prevent missed calibration activities. In an eQMS platform, calibration records are stored in a centralized, secure repository equipped with audit trails and electronic signatures. Built-in workflows facilitate the review and approval of calibration data, enforce role-based access controls, and protect records from unauthorized changes. By replacing manual tracking with digital controls, an eQMS reduces human error and improves visibility into equipment status, while improving overall audit readiness.

SimplerQMS provides an eQMS software for pharmaceutical companies. SimplerQMS enables organizations to manage calibration processes alongside document control, CAPA management, training management, and supplier management, among others.

SimplerQMS supports compliance with key requirements in the pharmaceutical industry, such as FDA 21 CFR Part 211 and EU GMP, helping companies maintain inspection readiness and streamline quality operations.

SimplerQMS complies with FDA 21 CFR Part 11 and EU Annex 11, fulfilling the GMP requirements for computerized systems, and is fully validated according to ISPE GAMP 5.