FDA 21 CFR Part 11: Definition, Compliance Requirements, Benefits, and Software

21 CFR Part 11 is a regulation established by the U.S. Food and Drug Administration (FDA) to ensure the integrity, reliability, and authenticity of electronic records and electronic signatures.

The purpose of 21 CFR Part 11 is to enable industries to transition from paper-based systems to electronic data management while maintaining compliance with FDA regulations. 21 CFR Part 11 applies to all FDA-regulated industries, including pharmaceuticals, biotechnology, and medical devices.

The main software requirements for 21 CFR Part 11 compliance include system validation to ensure accuracy and reliability, audit trails to document changes to records, robust security controls to prevent unauthorized access, operational controls for maintaining data integrity, and comprehensive personnel training.

Additionally, 21 CFR Part 11 compliant systems must generate complete and accurate electronic records and securely manage electronic signatures to meet regulatory requirements.

21 CFR Part 11 compliant software plays an important role in helping organizations securely manage electronic records and signatures. Such software ensures compliance with FDA regulations through features like audit trails, data security, electronic signature management, and automated recordkeeping. It provides user access controls to restrict data modification to authorized personnel, enhancing overall operational efficiency and regulatory compliance.

SimplerQMS is an example of 21 CFR Part 11 compliant software, offering a comprehensive eQMS solution for life science companies. Explore how SimplerQMS can support your organization in achieving compliance and enhancing operational efficiency by booking a demo today.

What Is 21 CFR Part 11?

21 CFR Part 11 is a U.S. Food and Drug Administration (FDA) regulation that outlines the requirements for electronic records and electronic signatures.

The purpose of 21 CFR Part 11 is to ensure the integrity, reliability, and authenticity of electronic records and signatures. This regulation applies to all FDA-regulated products. These products include those in life science industries such as pharmaceuticals, biotechnology, and medical devices.

The FDA introduced 21 CFR Part 11 in 1997 to accommodate the growing reliance on electronic data processing within regulated industries. The regulation permits the use of electronic records in place of paper documents, provided they adhere to specified requirements for security and integrity.

The main objectives of 21 CFR Part 11 are listed below.

• Authenticity: To ensure the integrity and authenticity of electronic records.
• Regulatory Compliance: To uphold adherence to regulatory requirements
• Efficiency: To enhance documentation processes through secure electronic systems.

21 CFR Part 11 serves as a framework ensuring the integrity, security, and traceability of electronic records in regulated industries. This regulation permits modernization in the regulated industries by enabling streamlined, secure, and efficient data management.

What Are 21 CFR Part 11 Compliance Requirements?

21 CFR Part 11 compliance requirements are divided into three main subparts which include Subpart A (General Provisions), Subpart B (Electronic Records), and Subpart C (Electronic Signatures), each focusing on different aspects of managing electronic records and signatures.

• Subpart A – General Provisions: Outlines the scope, implementation, and definitions.
• Subpart B – Electronic Records: Includes the controls for closed systems, controls for open systems, signature manifestations, and signature/record linking.
• Subpart C – Electronic Signatures: Provides general requirements for electronic signatures, electronic signature components and controls, and controls for identification codes/passwords.

Subpart A – General Provisions

Subpart A of 21 CFR Part 11, titled “General Provisions,” sets the foundational framework for the regulation. It outlines the scope, implementation, and definitions necessary to ensure that electronic records and electronic signatures are trustworthy, reliable, and essentially equivalent to paper records and handwritten signatures.

The sections included in Subpart A are listed below.

• Section 11.1 Scope: Defines the applicability of the entire regulation.
• Section 11.2 Implementation: Provides guidelines on how regulated entities should implement the provisions of 21 CFR Part 11.
• Section 11.3 Definitions: Gives definitions for terms used throughout the regulation.

Section 11.1 Scope

Section 11.1 Scope under Subpart A – General Provisions defines the applicability of the entire regulation. This subpart clarifies that 21 CFR Part 11 applies to all FDA-regulated industries that choose to use electronic records and electronic signatures.

Section 11.1 specifies that the regulation covers electronic records, electronic signatures, and their implementation. Furthermore, the regulation stipulates that systems handling these records must be available for FDA inspection. It further outlines specific exemptions for certain records and electronic signatures under different parts of the regulation (e.g. subpart R Laboratory Accreditation for Analyses of Foods).

Section 11.2 Implementation

Section 11.2 Implementation provides guidelines on how regulated entities should implement the provisions of 21 CFR Part 11. It focuses on ensuring that electronic records systems are capable of producing accurate and reliable results throughout their operational life.

The section explains that for records required to be maintained but not submitted to the FDA, electronic records and signatures can replace paper records and traditional signatures, as long as the regulatory requirements are met. For records being submitted to the FDA, electronic records and signatures can also replace paper and traditional signatures, but only if the specific document types are identified in public docket No. 92S-0251. This docket specifies which documents can be submitted electronically and to which agency units. If a document is not listed in the docket, it must be submitted in paper form along with any electronic records.

Section 11.3 Definition

Section 11.3 Definitions is a section that offers precise definitions for terms used throughout the regulation, such as “electronic record”, “electronic signature”, “closed system” and “open system.” These definitions are critical for understanding the requirements and ensuring compliance with the regulation.

The definitions of terms from 21 CFR Part 11 that apply to this article are listed below.

• An electronic record is defined by the 21 CFR Part 11 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.”
• Electronic signature means 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.”
• A closed system means “an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.”
• Open system pertains to “an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.”   

Subpart B – Electronic Records

Subpart B of 21 CFR Part 11, named “Electronic Records,” details the requirements for electronic records to ensure their integrity, authenticity, and confidentiality. This subpart mandates specific controls and procedures for managing electronic records, emphasizing the importance of secure and reliable record-keeping systems.

The subpart B includes the following sections listed below.

• Section 11.10 Controls for Closed Systems: Specifies the requirements for closed systems used to manage electronic records.
• Section 11.30 Controls for Open Systems: Addresses the controls necessary for open systems, which are more vulnerable to unauthorized access
• Section 11.50 Signature Manifestations: Outlines the requirements for electronic signatures attached to electronic records.
• Section 11.70 Signature and Record Linking: Ensures that electronic signatures are permanently linked to their respective electronic records.

Section 11.10 Controls for Closed Systems

Section 11.10 Controls for Closed Systems specifies the requirements for closed systems used to manage electronic records. It mandates that closed systems must have adequate controls to ensure the authenticity, integrity, and confidentiality of electronic records. Measures include limited system access to authorized individuals, and the use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.

The procedures and controls for closed systems are listed below.

• System validation for accuracy, reliability, consistent performance, and detecting invalid records
• Ability to generate accurate and complete records in human-readable and electronic forms
• Protection of records and easy retrieval during the retention period
• Limited access to authorized individuals
• Use of secure and time-stamped audit trails to record operator entries and actions
• The operational system checks to enforce proper sequencing of events
• Authority checks to ensure only authorized individuals can use the system
• Device checks to validate data input source
• Training and qualifications of personnel using the electronic record and electronic signature systems to perform their tasks
• Written policies to hold individuals accountable for actions initiated under their electronic signatures
• Controls for systems documentation distribution, access, revision, and change procedures.

Section 11.30 Controls for Open Systems

Section 11.30 Controls for Open Systems section addresses the controls necessary for open systems, which are more vulnerable to unauthorized access due to personnel responsible for the electronic records do not control access to the system.

Section 11.30 requires that records be protected to ensure their integrity, authenticity, and confidentiality. Personnel involved in creating, modifying, storing, or sending electronic records must ensure that these records are authentic, accurate, and secure.

Additional measures such as encryption and the use of appropriate digital signature technologies are required to secure the records.

Furthermore, the procedures and controls include those for closed systems, as well.

Section 11.50 Signature Manifestations

Section 11.50 Signature Manifestations outlines the requirements for electronic signatures attached to electronic records.

The section specifies that the printed name of the signer, and the date and time when the signature was executed are included for electronic signatures. Additionally, the meaning or purpose associated with the signature (such as review, approval, or responsibility) must be included as part of any electronic record to which the signature is linked.

The information for the name, date, time, and purpose needs to be recorded and included in all forms of readable documents, such as electronic displays or printouts.

Section 11.70 Signature and Record Linking

Section 11.70 Signature and Record Linking ensures that electronic signatures are permanently linked to their respective electronic records.

This linkage must be implemented in a way that prohibits any attempt to falsify a signature or to alter the record without detection.

Electronic Signatures

Subpart C of 21 CFR Part 11, titled “Electronic Signatures,” establishes the criteria under which electronic signatures and their components are considered secure and reliable. This subpart ensures that electronic signatures are as trustworthy as their handwritten counterparts.

The sections of Subpart C – Electronic Signatures are listed below.

• Section 11.100 General Requirements: Sets forth the general requirements for the use of electronic signatures.
• Section 11.200 Electronic Signature Components and Controls: Details the components and controls necessary for electronic signatures.
• Section 11.300 Controls for Identification Codes and Passwords: Outlines the controls required for managing identification codes and passwords that are used as part of electronic signatures.

Section 11.100 General Requirements

Section 11.100 General Requirements sets forth the general requirements for the use of electronic signatures.

It mandates that each electronic signature must be unique to one individual and should not be reused by, or reassigned to, any other person.

An organization must confirm a person’s identity before permitting them to use an electronic signature.

Additionally, the regulation requires verification of the identity of the individual using the electronic signature.

Section 11.200 Electronic Signature Components and Controls

Section 11.200 Electronic Signature Components and Controls details the components and controls necessary for electronic signatures.

It specifies that electronic signatures that do not use biometrics must consist of at least two distinct identification components such as an identification code and a password. The first signature in a series of signings during a single, continuous period of system access must use all electronic signature components. Subsequent signings must use at least one component, usually the password.

Additionally, section 11.200 requires that electronic signatures be designed to ensure that they cannot be readily forged, transferred, or used by other personnel and only by the owner. The system must require the collaboration of at least two individuals if someone other than the owner needs to use an electronic signature.

Section 11.300 Controls for Identification Codes and Passwords

Section 11.300 Controls for Identification Codes and Passwords outlines the controls required for managing identification codes and passwords that are used as part of electronic signatures.

The controls for the identification of codes and passwords include the following.

• Ensuring each identification code and password combination is unique.
• Regularly reviewing and updating codes and passwords to prevent aging.
• Implementing procedures to manage lost or stolen access credentials.
• Preventing unauthorized use of codes and passwords, with immediate reporting of any such attempts.
• Regular testing of devices, like tokens or cards, that generate or store these codes to ensure they function properly and are not tampered with.

How Does 21 CFR Part 11 Apply to Pharmaceutical Companies?

21 CFR Part 11 applies to pharmaceutical companies by regulating the use of electronic records and electronic signatures to ensure their reliability and compliance with FDA requirements. This requirement is crucial for maintaining the credibility and reliability of electronic documentation in the pharmaceutical industry.

Pharmaceutical companies must implement systems that maintain data integrity, secure sensitive information, and provide audit trails to meet regulatory requirements in specific processes or applications.

Examples of processes and applications of 21 CFR Part 11 in pharmaceutical companies are listed below.

• Clinical Trials Management: Ensures the integrity of trial data and compliance with FDA regulations for electronic records.
• Manufacturing Record Management: Manages production data securely to meet Good Manufacturing Practice (GMP) requirements. Batch records ensure accuracy and traceability, allowing manufacturers to manage materials, processes, and potential recalls or defects.
• Quality Assurance: Requires maintaining audit trails and ensuring data accuracy during quality control processes. Secure electronic documentation (e.g., encryption and audit logs) protects records from unauthorized changes and meets FDA inspection requirements.
• Regulatory Submissions: Streamline the creation and submission of electronic records for FDA approvals. Validated electronic systems help reduce errors, facilitate compliance, and speed up the approval process for new or modified devices.

How Does 21 CFR Part 11 Apply to Medical Device Companies?

21 CFR Part 11 applies to medical device companies by governing the use of electronic records and signatures to ensure compliance with FDA regulations.

In the context of medical devices, this regulation is particularly relevant in areas such as product design, manufacturing, and quality assurance, where accurate and secure documentation is essential.

Examples of processes and applications of 21 CFR Part 11 in medical device companies are listed below.

• Design and Development Records Management: Ensures the traceability and accuracy of design documentation for regulatory approval.
• Manufacturing Records Management: Manages production data to maintain compliance with the FDA’s Quality System Regulation (QSR).
• Quality Management Systems (QMS): Maintains secure and auditable records for quality assurance and compliance with 21 CFR Part 820.
• Post-Market Surveillance: Manages electronic records for complaint handling, adverse event reporting, and corrective actions.

What Are the Key 21 CFR Part 11 Software Requirements?

A 21 CFR Part 11 compliant system should ensure that electronic records and signatures are reliable, reliable, and equivalent to paper records and handwritten signatures.

21 CFR Part 11 compliant system should comply with the following software requirements listed below.

• System Validation: Confirms that software functions correctly and adheres to regulatory requirements.
• Record Generation: Produces accurate, comprehensive, complete, and retrievable records.
• Audit Trails: Tracks modifications to ensure data accuracy and traceability.
• Operational Controls: Supports system reliability, functionality, and compliance with regulations.
• Security Controls: Safeguards data against unauthorized access or modifications.
• Personnel Training: Ensures users understand and properly operate the system.
• Electronic Signatures:Delivers secure and legally binding digital authorizations.

System Validation

System validation refers to the validation of a computerized system (e.g. software, hardware, or both) wherein it reliably performs its intended functions and meets applicable requirements.

Validated software must reliably capture, store, and retrieve data, to ensure record integrity.

As per 21 CFR Part 11.10(a), the system must be in a validated state to ensure that it is accurate, reliable, performs as intended, and can identify invalid or altered records.

Record Generation

Record generation refers to the creation, capture, and documentation of electronic records in a manner that ensures their accuracy, integrity, and authenticity. The software system must be able to produce accurate, complete copies of records in both human-readable and electronic form.

Several key sections about record generation in 21 CFR Part 11 are listed below.

• 21 CFR Part 11.10(b): Systems must ensure that records are accurate, complete, and secure against unauthorized changes.
• 21 CFR Part 11.10(c): Records must be retrievable in electronic forms throughout their retention period.
• 21 CR Part 11.10(e): Electronic records that have already been recorded cannot be covered by changes to the record.
• 21 CFR Part 11.30: Controls for open systems emphasize the importance of protecting records from unauthorized access or alterations during generation, transmission, or receipt.

Audit Trails

An audit trail is a detailed log of system activities, capturing changes, user actions, and data access for accountability and compliance.

The system must be able to log system activities and record the date and time of operator entries and actions that create, modify, or delete electronic records. Audit trails are crucial for maintaining a record of the sequence of activities that affect data integrity and traceability.

The specific provisions of audit trails in 21 CFR Part 11 are listed below.

• 21 CFR Part 11.10(e): Requires the use of secure, computer-generated, time-stamped audit trails to independently record the date and time of entries and actions that create, modify, or delete electronic records. These audit trails must be retained for the required record-keeping period and available for inspection and copying by the FDA.
• 21 CFR Part 11.10(k)(2): Mandates that audit trails must document changes made to electronic records, including who made the changes, what changes were made, and when they occurred.
• 21 CFR Part 11.30: For open systems, appropriate controls must be implemented to ensure the integrity of records, including ensuring that audit trails identified in 21 CFR Part 11.10 are in place to secure data integrity.

Operational Controls

Operational controls are policies and procedures designed to maintain system security, effectiveness, and compliance while managing risks.

The system should adhere to defined procedures for installation, configuration, testing, and continuous maintenance to maintain reliable performance and meet regulatory compliance.

The relevant operational control sections are listed below.

• 21 CFR Part 11.10(f): Requires to ensure that each step is completed correctly and in the proper order. This addresses control over system operations.
• 21 CFR Part 11.10(g): Mandates the use of operational system checks to enforce the sequencing of steps and events as specified by the system’s procedural requirements.
• 21 CFR Part 11.10(h): Requires the use of authority checks to ensure that only authorized personnel can use the system, access data, or execute specific actions.
• 21 CFR Part 11.10(i): Stipulates the need for device (e.g., system) checks to determine the validity of system input and output data.
• 21 CFR Part 11.30: Includes additional safeguards (for open systems), such as encryption or digital signatures, to ensure record integrity during transmission and handling.

Security Controls

Security controls are controls designed to protect systems, data, and networks from unauthorized access, breaches, or damage, ensuring the confidentiality, integrity, and availability of information.

The system must enforce strong authentication, encryption, access restrictions, and continuous monitoring to protect sensitive data and prevent unauthorized activities.

The key sections addressing security controls are listed below.

• 21 CFR Part 11.10(d): Systems must limit access to authorized individuals, ensuring only properly permitted users can access or modify electronic records.
• 21 CFR Part 11.10(e): Requires the use of secure, computer-generated, and time-stamped audit trails to record the identity of anyone who creates, modifies, or deletes an electronic record.
• 21 CFR Part 11.30: Open systems must have additional safeguards, such as encryption and digital signatures, to ensure the security and integrity of records during transmission.
• 21 CFR Part 11.200: When electronic signatures are used, they must be designed to prevent fraudulent use, ensuring security in signatory identification and authentication.
• 21 CFR Part 11.300: Requires identification codes and passwords, which ensure security and integrity.

Personnel Training

Personnel training is the process of providing employees with the required knowledge and skills to properly operate systems adhere to procedures and meet regulatory requirements.

The system needs to offer intuitive interfaces, clear documentation, and ongoing support to help employees perform tasks correctly and stay compliant with regulations.

The section related to personnel training is listed below.

• 21 CFR Part 11.10(i): Implies that personnel must be adequately trained in the operation and control of systems to ensure compliance.

Electronic Signatures

An electronic signature is a digital means of confirming an individual’s consent or approval of a document, providing authenticity and accountability in electronic transactions.

The system must authenticate the user’s identity, capture the electronic signature, and keep audit trails to ensure the integrity and traceability of the signed documents.

The requirements for electronic signatures are outlined in the following sections.

• 21 CFR Part 11.3: Electronic signature is directly defined 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.
• 21 CFR Part 11.70: Requires that electronic signatures be securely linked to their respective electronic records.
• 21 CFR Part 11.100: Requires that the electronic signature system must be protected from unauthorized use, unique to one individual, identity verification, and legally binding equivalent to the signer’s handwritten signature.
• 21 CFR Part 11.200: The record of the electronic signature must be maintained in accordance with the record retention requirements for the system, ensuring that the signature’s integrity and associated information are preserved for the required period.

What Are the Advantages of Complying With 21 CFR Part 11?

The benefits of complying with 21 CFR Part 11 which governs the use of electronic records and electronic signatures are listed below.

• Enhanced Data Integrity: Ensures that electronic records are accurate, reliable, and tamper-proof or tamper-evident, reducing the risk of data breaches or manipulation.
• Regulatory Compliance: Shows adherence to FDA requirements, reducing the risk of fines, penalties, or operational disruptions.
• Operational Efficiency:Streamlines processes by reducing reliance on paper automating recordkeeping tasks.
• Improved Security: Implements robust security measures to safeguard sensitive data from unauthorized access.
• Traceability and Auditability: Provides detailed audit trails and record linkage, simplifying the process of tracking and auditing changes to electronic records.
• Market Credibility: Enhances trust with stakeholders, including customers and regulatory authorities, by demonstrating commitment to high-quality standards. This credibility can improve brand reputation and consumer confidence.

What Additional Insights to Know About 21 CFR Part 11?

The additional insights to know about 21 CFR Part 11 are listed below.

• Validation: Validation decisions for computerized systems should be based on the system’s impact on product quality, safety, and record integrity, following a risk assessment.
• Audit Trail: Systems should implement audit trails based on a justified risk assessment, particularly for systems that modify or delete regulated records.
• Legacy Systems: Systems operational before August 20, 1997, are exempt from Part 11 compliance if they meet requirements and have documented fitness for use. Any changes post-1997 that affect compliance require Part 11 controls.
• Copies of Records: The FDA exercises discretion on the requirements for generating copies of electronic records. Companies should provide copies in common formats (examples of such formats but not limited to PDF, XML), preserving the records’ content and meaning, with capabilities for search and review if possible.
• Record Retention: The FDA is flexible regarding the retention of records as long as companies comply with applicable rules for retention and retrieval. Records may be archived in electronic or non-electronic formats (e.g., paper, microfilm) if the content and meaning are preserved.

What is the European Equivalent of 21 CFR Part 11?

EU Annex 11, which pertains to Computerized Systems, is the European equivalent of 21 CFR Part 11. EU Annex 11 is part of the European Union’s Good Manufacturing Practice (GMP) guidelines. It provides criteria to ensure that electronic records and electronic signatures are trustworthy, reliable, and equivalent to paper records and handwritten signatures including in the regulated life sciences sector such as pharmaceutical companies.

EU Annex 11 covers similar aspects as 21 CFR Part 11, including system validation, data integrity, audits, system accessibility, and security measures. It mandates that companies operating within the EU must have systems that are validated, which can generate accurate and reliable results, and are equipped with adequate security features to prevent unauthorized access or changes to data. Additionally, like 21 CFR Part 11, EU Annex 11 requires detailed audit trails for actions related to electronic records.

Key points from EU Annex 11 are listed below.

• Risk Management: Throughout the system lifecycle, risk management should ensure patient safety, data integrity, and product quality. Validation extent and data integrity should be based on risk assessments.
• Personnel: Relevant personnel must have appropriate qualifications and defined responsibilities.
• Suppliers and Service Providers: Agreements with third parties must clearly define responsibilities, and suppliers should be selected based on competence and reliability.
• Validation: Validation documentation must cover lifecycle steps, include change control and deviations, and ensure compliance with GMP.
• Data Management: Systems should ensure secure and accurate data entry, storage, and accessibility. Backup and audit trail procedures must be in place.
• Security: Access controls should restrict unauthorized system entry, with recorded user actions for critical processes.
• Incident Management: All incidents, including system failures, must be reported and assessed to identify corrective actions.
• Electronic Signatures: Electronic signatures must be permanently linked to records and contain time and date stamps.
• Batch Release: Systems used for batch release must restrict certification to Qualified Persons and use electronic signatures.
• Business Continuity: Backup systems should be in place for critical processes to ensure continuity in case of system failure.
• Archiving: Archived data must be accessible, readable, and secure.

What is the Difference Between 21 CFR Part 11 and EU Annex 11?

The main differences between 21 CFR Part 11 and EU Annex 11 primarily revolve around their geographical applicability, risk management, and emphasis on the validation process.

21 CFR Part 11, issued by the U.S. Food and Drug Administration (FDA), specifically addresses the requirements for electronic records and electronic signatures in the United States. It outlines criteria under which electronic records and signatures are trustworthy, reliable, and equivalent to paper records and handwritten signatures. The regulation is particularly stringent about system validation with general validation requirements in open and closed computer systems. Furthermore, 21 CFR Part 11 applies to regulated industries such as pharmaceuticals, medical devices, and biotechnology.

EU Annex 11, part of the European Union’s Good Manufacturing Practice (GMP) guidelines, serves a similar purpose but is tailored to the regulatory environment of the EU. It requires that all aspects of the computerized system lifecycle be managed according to the principles of quality risk management, ensuring consistent, controlled environments. More detailed validation criteria (IQ/OQ/PQ, life cycle management) are mentioned in EU Annex 11. It focuses on risk-based quality management of computerized systems.

Although the document is GMP guidelines for Medicinal Products for Human and Veterinary Use, this applies to any industry subject to EU regulations where electronic systems are used to handle data, especially in areas that affect public health, safety, and product quality.

What Is the Role of 21 CFR Part 11 Compliant Software?

21 CFR Part 11 compliant software is designed to help organizations in FDA-regulated industries meet the requirements for managing electronic records and electronic signatures securely and efficiently.

It is important to distinguish between 21 CFR Part 11 compliance software and 21 CFR Part 11 compliant software. 21 CFR Part 11 compliance software is a type of software designed specifically to help organizations meet regulatory requirements. On the other hand, 21 CFR Part 11 compliant software meets regulatory requirements or complies with a specific set of requirements that apply to the software itself.

The key functionalities of 21 CFR Part 11 compliant software are listed below.

• Validated State: Ensures the system is fully validated, meets validation requirements, and is revalidated whenever new versions or updates are introduced.
• Audit Trails: Tracks system activities to provide detailed logs, supporting transparency and compliance during inspections.
• Data Security: Protects data through encryption, secure storage, and other safeguards to prevent unauthorized access.
• Electronic Signatures: Ensures the secure application and verification of electronic signatures, making them legally equivalent to handwritten signatures.
• Automated Recordkeeping: Facilitates the efficient creation, storage, and retrieval of records in line with FDA regulations.
• User Access Controls: Restricts access to sensitive data based on user roles, ensuring that only authorized personnel can modify critical information.

SimplerQMS is a 21 CFR Part 11 compliant software that also aligns with EU Annex 11, making it a comprehensive platform for quality management and documentation.

SimplerQMS supports all QMS processes including document management, employee training, change control, CAPA management, complaint management, audit management, supplier management, and more.

Our eQMS software supports compliance with various life science requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 210, 211, and 820, EU GMP Annex 11, EU GMP, and more. SimplerQMS software provides comprehensive support for QMS processes, assisting companies in meeting the required standards and regulations.

To see how SimplerQMS can help your organization maintain compliance and improve operational efficiency, consider booking a demo today.