21 CFR Part 11

21 CFR Part 11

21 CFR Part 11 is a regulation issued by the United States Food and Drug Administration (FDA) that establishes criteria for electronic records and electronic signatures. It applies to companies that create, modify, maintain, or transmit electronic records related to drug or device manufacturing, testing, and distribution.

21 CFR Part 11 refers to software systems that meet the criteria set forth in the regulation. These criteria include requirements for:

  • Security: the software must have controls in place to ensure the confidentiality, integrity, and availability of electronic records.
  • Audit trails: the software must be able to record and retain information about every change made to an electronic record, including who made the change and when.
  • Electronic signatures: the software must have controls in place to ensure that electronic signatures are unique, cannot be transferred, and are linked to the individual signing the record.
  • Validation: the software must be validated to ensure that it functions as intended and meets the requirements of the regulation.

21 CFR Part 11 is important for companies that operate in regulated industries to ensure compliance with FDA regulations and to maintain the safety and efficacy of their products. Software vendors that offer 21 CFR Part 11 compliant software typically provide documentation and support to help their customers meet the regulation’s requirements.

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Instech JM.S Development and Function:

Instech JM.S includes a set of functions for responding to the requirements specified in FDA 21 CFR Part 11. The standard is intended to provide a solution for securely handling electronic records and electronic signatures in industrial applications.

User Management Security

  • Instech JM.S provides customizable user group dynamics
  • You can restrict access to various widgets and operations by configuring users, user groups and assigning specific authorizations to each group
  • Max User Groups = 50
  • Max Users = 500
  • Each user must be member of one and only one group. Each group has specific authorizations and permissions.
  • By organizing permissions and groups you can define the security options of a project
21 CFR Part 11 compliant software
21 CFR Part 11

Instech Systems is a leading manufacturer, supplier, and exporter based in Meerut, Uttar Pradesh, specializing in solutions compliant with 21 CFR Part 11 regulations. Our company is dedicated to providing high-quality products that meet stringent industry standards, ensuring the integrity and security of electronic records and signatures.

At Instech Systems, we pride ourselves on our state-of-the-art manufacturing processes and rigorous quality control measures. Our product range is designed to cater to the diverse needs of the pharmaceutical, biotechnology, and medical device industries, ensuring compliance with global regulatory requirements.

We offer a comprehensive suite of solutions that include data logging systems, secure access control, and audit trail capabilities, all essential for maintaining compliance with 21 CFR Part 11. Our team of experts works closely with clients to deliver customized solutions that enhance operational efficiency while safeguarding critical data.

With a strong focus on innovation and customer satisfaction, Instech Systems has established a reputation for excellence in both domestic and international markets. Our commitment to quality and compliance makes us a trusted partner for businesses seeking reliable and effective solutions for regulatory adherence and data management.

1. Electronic Records: Electronic records are a natural extension of the traditional use of paper records. Paper records mainly provide data security and can carry handwritten signatures to indicate that certain data is correct. Attempted corruption of either the data or signature is readily detectable. Electronic records are required to provide secure data, which can provide a high level of confidence. Outlining its value, here are some advantages of using electronic records:

  • Secure process values and audit trials (alarms, events, operator actions, log-in/log-out, operator notes, electronic signatures)
  • Protection of data through compressed, binary, and check-summed records
  • Accurate time stamps are fortified using automatic time synchronization to a known clock source
  • Provision for electronically copying data for archive
  • An export facility providing visibility of secure records in readable form


2. Electronic Signatures: Electronic signatures are popular because they are easy to use. Customers can sign documents online with a click of the mouse or by using their fingers to trace a handwritten signature onto a document. The downfall of electronic signatures is that they aren’t regulated like digital signatures are. It’s up to each vendor to set their standards. Below mentioned are the advantages of electronic signatures.

  • All user actions can be configured to require signing or authorization
  • User-specific access according to authority level
  • The signature element controls unique user signature, password expiry, minimum password length, automatic log-off, automatic disabling and notification of failed login attempts
  • Ensuring unique users by retiring and not deleting accounts
  • Electronic signatures require both operators and supervisors to identify themselves electronically in such a way as to be equivalent to handwritten signatures. This also allows the use of
  • biometrics such as fingerprint or retinal scan devices. The advancement in electronic systems offers significant benefits for data retrieval and storage of data. FDA developed the 21 CFR
  • Part 11 rule to describe what they require for securing electronic records and signatures.
Frequently Asked Questions (FAQs)

The primary purpose of 21 CFR Part 11 is to define the requirements for the use of electronic records and electronic signatures in FDA-regulated industries. It ensures that electronic records are secure, reliable, and legally binding, just like traditional paper records and handwritten signatures.

Industries that are subject to FDA regulations, such as pharmaceuticals, biotechnology, medical devices, food manufacturing, and clinical research, are typically affected by 21 CFR Part 11.

Electronic records are any information created, modified, maintained, archived, retrieved, or transmitted electronically, including text files, databases, spreadsheets, and other digital formats.

Electronic signatures are digital representations of handwritten signatures, which can be used to sign electronic records. These signatures are used to authenticate and link an individual to the electronic record.

Non-compliance with 21 CFR Part 11 can result in regulatory actions, including warning letters, fines, product recalls, and legal consequences. It’s essential for regulated industries to ensure compliance to avoid these risks.

Achieving compliance involves implementing appropriate policies, procedures, and technologies to ensure the secure and reliable use of electronic records and signatures. This typically includes system validation, data encryption, access controls, and the establishment of audit trails.