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FDA 21 CFR Part 11 Compliance Checklist

21 CFR Part 11 Compliance Checklist

21 CFR Part 11 Compliance Checklist – Key Things to Know

A guide to how a company can submit documentation in an electronic form and the criteria for approved electronic signatures set by FDA

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What is 21 CFR Part 11 Compliance?

FDA’s 21 CFR Part 11 is a regulatory framework guiding companies on creating and managing digital records and signatures. Facilitating regulatory oversight is the core focus of 21 CFR Part 11, while the driving force is to ease the cost and burden of maintaining paper records to satisfy regulators.

FDA 21 CFR part 11

21 CFR part 11 Compliance Checklist and Requirements

21 CFR Part 11 compliance checklist and requirements can be broken down into six key requirements that must be met for compliance.

  • 1
    Limited Access : Limiting access only to authorized users is essential to ensure the legitimacy of the records and signatures for audit. Each user should have a unique set of login credentials that enable all of their activities to be identified. It is also vital to be able to illustrate the access controls in place.
  • 2
    Audit trails : Audit trails support the access controls requirements with proof of operator access and creating a system of records. A significant factor of 21 CFR part 11 compliant software is the way electronic records are created, modified, reviewed, approved, and controlled.
    • Does the system feature time to facilitate audit trails for every document and record? Does the audit trail indicate who modified the record, when was the date and time the record was modified, and what specific items in the record were modified? Is the audit trail easily restored and demonstrated?
    • Does the system implement 21 CFR part 11 digital signatures? 21 CFR part 11 compliant electronic signatures attest to the creation, review, or approval by an authorized person.
  • 3
    Written policies : All policies connected with operating and maintaining the hardware, software, and physical records of the organization should be clearly documented. These policies should be covered fully during training for anyone with access to the records.
  • 4
    Validation testing : Regular system validation checks are conducted and logged to meet compliance requirements. FDA auditors must be able to trust the data integrity they are being presented with. Here are some checklists to assess for FDA 21 CFR part 11 validation including:
    • Does the system comply with FDA 21 CFR part 11 security requirements? Does each authorized user have a unique username and password? Is the system data encrypted?
    • Is there an SOP that manages how the system is used, who can use it, and for what purpose?
    • Does the system maintain records within the defined record retention period for each record type?
  • 5
    Digital signatures : 21 CFR Part 11 is focused on electronic records, streamlining activities, and digital signatures. For digital signatures to be compliant, they must be computed by using a set of rules and parameters such that the identity of the signer and the integrity of the data can be verified.
  • 6
    Training : 21 CFR Part 11 also requires that all users with access to the system be properly trained in the protocols. Employees should be trained for their specific roles and made aware of the limitations of their access and responsibilities. All training should be completely documented so that auditors can easily review the operator audit trail and cross-reference it with the training logs.

What are the Critical Requirements of 21 CFR Part 11?

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    21 CFR Part 11 requires that all elements of the system are working and develop the scripts and testing routines to validate that it is functioning. Validating the EQMS ensures data security and audit logs as well as increases the integrity of record keeping.
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    Record generation
    21 CFR Part 11 specifies that the EQMS should have a search and indexing functionality so that records can be found quickly and easily. A good EQMS solution can have all document changes and iterations, as well as display the digital signatures of any approval.
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    Audit Trails
    A good QA function associated with audit history ensures that the development of all processes is well documented and traceable to a specific originator. This audit history should be automatically generated.
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    Operational Controls
    A sophisticated EQMS will allow for quality procedures to be monitored and ensure that documents are reviewed by specified individuals and that they meet certain requirements before they are signed off and the contingency phase begins.
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    Security Controls
    Access to a system should be controlled by a unique login and password for every user. EQMS can determine the number of people who can alter certain documents, track each version of the file, as well as identify those who have altered it in the past. Final records should be read-only.
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    Digital Signatures
    A good EQMS will give administrators complete visibility and control over the use of signatures across the systems. They can create and cancel signature requests along with setting the locations where signatures can be used to protect against fraud.
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    21 CFR Part 11 stresses that all system users should have the essential training to perform their assigned tasks and projects. An EQMS can itself assist with these requirements by accepting conditions upon signing in to the system or by documenting this responsibility as part of training.

How to Track With 21 CFR Part 11 Compliance Checklist?

21 CFR part 11 compliance checklist helps evaluate a system’s CFR 21 part 11 compliance. 21 CFR Part 11 Compliance Checklist is necessary for companies to prove to regulators that the system is robust enough to meet their standards. A thorough 21 CFR Part 11 compliance checklist guides businesses through the intricacies of regulatory requirements and helps organizations meet the relevant compliance standards. The 21 CFR Part 11 compliance checklist also helps improve processes and ensure that the business has the right systems and steps in place. The 21 CFR part 11 Compliance Checklist helps identify areas of risk. To track with 21 CFR part 11 Compliance Checklist, the following are essential:

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    Assess whether 21 CFR Part 11 applies to your company
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    Follow 21 CFR Part 11 data security and password protection best practices
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    Establish clear audit trails for traceability
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    Follow 21 CFR Part 11 guidelines on electronic signatures
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    Validate For IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification)
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    Consider 21 CFR Part 11 compliance when choosing a QMS solution.

Why FDA 21 CFR Part 11 matters?

FDA 21 CFR Part 11 matters for the following reasons:

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    Security controls for user identification:
    21 CFR Part 11 compliant systems must have security features that limit user access and their privileges based on roles and responsibilities to prevent unauthorized system access.

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    Detailed audit trail:
    For an audit trail, you must use the software that is capable of keeping a daily record of all functions initiated by the user or the software.

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    Electronic signatures:
    21 CFR Part 11 compliant systems can assign unique electronic signatures to each user and are legally binding.

Achieving FDA 21 CFR Part 11 with ComplianceQuest

ComplianceQuest (CQ) enables 21 CFR Part 11 FDA compliance for life sciences organizations such as healthcare, pharmaceutical, biotechnology, medical manufacturing, medical devices, and other FDA-regulated industries. It facilitates implementing controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems that are involved in processing many forms of data, business practices and product development. 21 CFR Part 11 executes the FDA’s requirement to recognize electronic records and electronic signatures as trustworthy, reliable, and legal equivalents to paper records and handwritten signatures. This also allows companies to adopt a ’paperless’ system of record keeping.

What Industries does FDA 21 CFR Part 11 Apply to?

21 CFR Part 11 applies to all electronic records or signatures that are maintained, created, or processed under any records requirements as defined by the FDA. Any records that are stored, signed, or processed digitally for biotech, life science, or other FDA regulated companies fall under the regulation.

It primarily applies to businesses operating in the US in the biotech, life science, medical instrumentation, or similar industries. Many non-food businesses that are within the jurisdiction of the FDA must meet 21 CFR Part 11 compliance. In the present times, it is difficult to maintain a fully-paper record, so almost all businesses in these sectors are affected.

Frequently Asked Questions

Why is 21 CFR Part 11 critical for researchers working in regulated environments?
The requirements of 21 CFR Part 11 not only ensure the integrity, authenticity, and confidentiality of raw electronic data, but also the non-repudiation of electronic signatures. It’s the researcher’s responsibility for demonstrating that the instruments and software used to collect and analyze data are validated to meet the 21 CFR 11.
Benefits of 21 CFR Part 11 Compliance

The objective of the regulation is to streamline compliance and allow businesses to speed up their operations with electronic records management systems and signatures. These compliance guidelines are especially important when implementing a software solution that is designed to facilitate 21 CFR Part 11 compliance.

Here are some of the benefits of 21 CFR Part 11 compliance including:

  • Better operational efficiency
  • Low expenses
  • Enhanced system security
  • In-built efficient employee training
  • Huge savings on storage space
  • Simplified patent filing

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