{"id":386,"date":"2026-11-11T17:43:48","date_gmt":"2026-11-11T12:13:48","guid":{"rendered":"https:\/\/incepbio.com\/blog\/?p=386"},"modified":"2026-11-11T17:52:29","modified_gmt":"2026-11-11T12:22:29","slug":"21-cfr-part-11-compliance-software","status":"publish","type":"post","link":"https:\/\/incepbio.com\/blog\/21-cfr-part-11-compliance-software\/","title":{"rendered":"21 CFR Part 11 Compliance Software: 7 Essential Features for Pharma Companies"},"content":{"rendered":"\t\t
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A batch record is approved late on a Friday. On Monday, an auditor asks who changed a test result, when the change happened, and why. If the supporting information is scattered across spreadsheets, shared logins, and printed documents, reconstructing the evidence can become difficult.<\/p>\n\t\t\n<\/div>\n

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That is one reason pharmaceutical companies look for 21 CFR Part 11 compliance software<\/strong>. Part 11 is the US Food and Drug Administration (FDA) regulation that establishes criteria for electronic records and electronic signatures to be considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.<\/p>\n\t\t\n<\/div>\n

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Software can help organisations manage the technical controls required for electronic records. However, purchasing software does not automatically make a company compliant. Compliance also depends on intended use, system configuration, validation, procedures, employee training, and ongoing controls.<\/p>\n\t\t\n<\/div>\n

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This guide explains what 21 CFR Part 11 covers and how it applies to pharmaceutical manufacturing. It also explores seven essential software features, vendor selection considerations, and the role of digital validation in supporting compliance.<\/p>\n\t\t\n<\/div>\n

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What Is 21 CFR Part 11?<\/strong><\/h2>\n\t\t\n<\/div>\n
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21 CFR Part 11 is an FDA regulation covering electronic records and electronic signatures. It establishes the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed on electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper (21 CFR \u00a711.1(a)).<\/p>\n\t\t\n<\/div>\n

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The regulation is organised into three subparts:<\/p>\n\t\t\n<\/div>\n

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01<\/div>\n
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Subpart A \u2013 General Provisions (\u00a7\u00a711.1\u201311.3)<\/span><\/div>\n
Defines the scope, implementation requirements, and key terms.<\/div>\n <\/div>\n <\/div>\n\n
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02<\/div>\n
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Subpart B \u2013 Electronic Records (\u00a7\u00a711.10\u201311.70)<\/span><\/div>\n
Covers controls for closed and open systems, signature manifestations, and signature-to-record linking.<\/div>\n <\/div>\n <\/div>\n\n
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03<\/div>\n
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Subpart C \u2013 Electronic Signatures (\u00a7\u00a711.100\u201311.300)<\/span><\/div>\n
Establishes requirements for electronic signatures, signature components, identification codes, and passwords.<\/div>\n <\/div>\n <\/div>\n\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Part 11 does not independently determine which records a pharmaceutical company must create or retain. Other applicable FDA regulations, commonly called predicate rules<\/em>, set those requirements. For pharmaceutical manufacturers, these include 21 CFR Part 211, which sets out current good manufacturing practice (CGMP) requirements for finished pharmaceuticals.<\/p>\n\t\t\n<\/div>\n

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Under \u00a711.1(b), Part 11 applies to electronic records created, modified, maintained, archived, retrieved, or transmitted under FDA record requirements. It also covers certain electronic records submitted to the FDA under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.<\/p>\n\t\t\n<\/div>\n

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The FDA’s September 2003 Part 11 guidance<\/a>, Part 11, Electronic Records; Electronic Signatures \u2013 Scope and Application<\/em>, explains the agency’s narrower interpretation of Part 11 scope. For example, a record required under a predicate rule may fall within Part 11 when it is maintained electronically in place of paper. A record maintained in both formats may also fall within scope when the organisation relies on the electronic version to perform regulated activities.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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The guidance recommends assessing records against applicable predicate rules and documenting decisions about whether electronic records fall within Part 11. The organisation's actual business practices and reliance on electronic records matter.<\/p>\n\t\t\n<\/div>\n

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Part 11 distinguishes between closed and open systems based on how access to electronic records is controlled.<\/p>\n\t\t\n<\/div>\n

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A closed system<\/strong> is one in which access is controlled by people responsible for the content of the electronic records on that system (\u00a711.3(b)(4)).<\/p>\n\t\t\n<\/div>\n

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An open system<\/strong> is one in which access is not controlled by people responsible for the content of the electronic records (\u00a711.3(b)(9)).<\/p>\n\t\t\n<\/div>\n

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The main distinction is the following:<\/p>\n\t\t\n<\/div>\n

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\n Closed systems:<\/strong> Must use the procedures and controls described in \u00a711.10. These include system validation, access restrictions, audit trails, and checks of authority.\n <\/p>\n <\/div>\n\n

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\n Open systems:<\/strong> Must use procedures and controls that protect the authenticity, integrity, and, where appropriate, confidentiality of electronic records from creation to receipt. Under \u00a711.30, these include the \u00a711.10 controls as appropriate, along with additional measures such as document encryption and appropriate digital-signature standards when necessary.\n <\/p>\n <\/div>\n\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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A system's hosting arrangement alone does not determine whether it is open or closed. Organisations should assess how access is controlled and document the classification with appropriate quality and regulatory input.<\/p>\n\t\t\n<\/div>\n

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7 Essential Features of 21 CFR Part 11 Compliance Software<\/strong><\/h2>\n\t\t\n<\/div>\n
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1. Secure Electronic Records<\/strong><\/h3>\n\t\t\n<\/div>\n
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When evaluating software, pharmaceutical companies should look beyond product descriptions and check how each feature supports their actual regulatory and operational requirements.<\/p>\n\t\t\n<\/div>\n

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The following seven features map to relevant Part 11 provisions. The Part 11 requirement<\/strong> sections describe regulatory provisions, while the Evaluate (recommended practice)<\/strong> sections suggest additional points to consider when selecting software.<\/p>\n\t\t\n<\/div>\n

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Why it matters:<\/strong><\/p>\n\t\t\n<\/div>\n

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Pharmaceutical companies manage several types of records, including batch manufacturing records, quality-control results, deviation reports, and equipment qualification documents. These records must remain authentic, complete, and accessible for their required retention periods.<\/p>\n\t\t\n<\/div>\n

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Part 11 requirement:<\/strong><\/p>\n\t\t\n<\/div>\n

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Section 11.10 requires procedures and controls designed to protect the authenticity, integrity, and, where appropriate, confidentiality of electronic records in closed systems.<\/p>\n\t\t\n<\/div>\n

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Section 11.10(b) requires the ability to generate accurate and complete copies of records in both human-readable and electronic forms suitable for FDA inspection, review, and copying.<\/p>\n\t\t\n<\/div>\n

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\n Evaluate (recommended practice):<\/strong>\n <\/p>\n\n