The New Digital Edge: Stay 21 CFR Part 11 Compliant

  • September 21, 2022
  • Reading Time: 6 minutes
Reading Time: 6 minutes

With the pandemic and numerous variants making it difficult for the processes to flow smoothly, digitization seems to be a great opportunity for seamless operations in the organization. e-Signature plays a huge role in digitizing, automating, and transforming content processes. Taking initial steps towards digitization? Adapting e-Signature can be one of the most successful parts of your organization’s overall digital transformation initiatives.

Especially for the ones in the biopharmaceutical or healthcare industry, taking up digitization initiatives is crucial. Organizations are required to enhance their document management system using e-Signing tools to address the increase in volume for signing processes but for the creation and management of their documents, especially as many organizations shift to hybrid work models. Along with that, being 21 CFR Part 11 compliant is also a must.

Every record is transformed from paper to digital formats. The transition to electronic form and paperless environment has a significant impact on the people working in well-regulated physical environments.

What is 21 CFR Part 11 exactly?

CFR (Code of Federal Regulations) are a set of rules that govern the management and usage of electronic records in the pharmaceuticals industry and medical industry.

Using digital documents and electronic signatures is becoming increasingly more frequent in FDA-regulated industries. 21 CFR Part 11 is an FDA regulation that outlines compliance requirements for electronic signatures and electronic records in these industries. This FDA regulation has two fundamental areas of enforcement: electronic signature and electronic records. These regulations can be of particular importance when it comes to paperwork, forms, and documents that are utilized within FDA-regulated industries.

The decoding of the phrase “21 CFR Part 11” is as follows:

  • 21” – This represents the 21st Title of the Code of Federal Regulation (CFR). Usually, this title outlines the rules of the FDA and is divided into three chapters.
  • CFR” – This stands for “Code of Federal Regulations.” Generally, this is a coded set of administrative laws. That is the codification of the permanent and general rules published in the Federal Register.
  • Part 11” – This outlines the guidelines to follow that regulate the e-Signatures and electronic records in pertinent industries.

Simply put, it is a guide on how an organization can submit documentation in an electronic form and brings in the criteria for an approved electronic signature. It is necessary for the computer systems to comply with the guidelines of 21 CFR Part 11 for the US FDA to accept the electronic records submitted for inspection.

What is Electronic Record & Electronic Signature in 21 CFR Part 11?

Electronic record means 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.

Who does 21 CFR part 11 apply to?

Everything comes under biopharmaceuticals and health care. Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs (contract research organizations), and other FDA-regulated industries, with some specific exceptions. Electronic records of all the forms must be compliant with part 11.

But the question is, are the companies ready for digital transformation yet?

As organizations have been following traditional methods with handwritten signatures for ages now, transforming to computerized systems has not been a necessary option.

The entire FDA-regulated industry must comply with 21 CFR part 11 rules. These include (but are not limited to):

  • Life sciences.
  • Pharmaceuticals.
  • Drug manufacturing.
  • Clinical / Contract Research Organization.
  • Clinical trials.
  • Clinical Supply Chain.
  • Medical device manufacturers.
  • Biotech.
  • Cosmetics.
  • Food and beverage manufacturers.

What is Digital Transformation?

Digital Transformation is basically a transformation of all the activities, processes, and competencies in such a way that lets us harness the advantages of new digital technologies. Electronic systems help organizations maintain the record authenticity and manage security as well.
Regardless of the industry, digital transformation comes with several benefits including:

  • Optimization of business operations
  • Access of the global markets
  • Elimination of the departmental silos
  • Smarter resource management
  • Greater customer centricity
  • Improved decision-making based on access to a great volume of information

Well, now if you are planning to take up digital transformation for your organization, now is the time. But having 21 CFR Part 11 compliance is necessary, hence, look out for these specialties in the tool that you select.

What should you consider when looking for 21 CFR Part 11 compliant software or instrument?

  • Security controls for user identification

The tools that you choose for Part 11 compliance should be mandatory with security features that limit user access and their privileges and help in the protection of records. Some examples of these security features include making sure users have unique usernames and passwords, being able to detect and prevent unauthorized system access, and even locking compromised accounts.

  • Detailed audit trail

When regulators arrive for inspections, you will need to provide a chronological record of all operations, namely an audit trail. Therefore, the computerized system chosen by you must be capable of keeping a daily record of all functions initiated by the user or software.

  • Electronic signature

Documents require an electronic signature. The system that you choose for Part 11 compliance must be able to assign a unique electronic signature to each user, which makes the electronic signature to be legally equivalent to a handwritten signature. Traditionally, handwritten signatures were legally accepted because every individual had unique signatures.

Choose Digital Transformation. Focus on the upgradation. Stay 21 CFR part 11 compliant with us! Cygnature is a blockchain-enabled digital signing solution. Cygnature’s 21 CFR Part 11 compliance module helps organizations stay 21 CFR Part 11 compliant and stay ahead of the competition.

Is Cygnature compliant to 21 CFR Part 11?

Yes, it is compliant. Cygnature is fully compliant to 21 CFR part 11 and helps clients to adhere to all CFR Part 11-related compliances.

  • The date and time the signature is made are present
  • The printed name of the signer is present
  • The signer has a unique signer ID
  • Digital signature technology is used
  • The reason for the signature is clearly stated in the documentation
  • Record a computer-generated timestamped audit trail
  • Authenticate the signer while applying the signatures
  • Use access code in combination with a password
  • All these are available as a part of the Cygnature 21 CFR Part 11 E-Signing module. Here is detailed information including every detail of the clauses that Cygnature’s 21 CFR Part 11 adheres to.
Clause No.Description
11.100(a)Each electronic signature must be unique to one individual and not reused by, or reassigned to, anyone else.
11.100(b)The identity of the individual must be verified before establishing, assigning, certifying, or otherwise sanctioning the individual’s electronic signature, or any element of such electronic signature.
11.200(a)(1)Electronic signatures that are not based upon biometrics must employ at least two distinct identification components such as an identification code and password.
11.200(a)(1)(i)When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing must be executed using all electronic signature components. Subsequent signings must be executed using at least one electronic signature component that is only executable by and designed to be used only by, the individual.
11.200(a)(1)(ii)When an individual executes one or more signings not performed during a single period of controlled system access, each signing must be executed using all of the electronic signature components.
11.300(a)The uniqueness of each combined identification code and password must be maintained such that no two individuals have the same combination of identification code and password.
11.300(d)The system must use transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use.
11.50(a)Signature appearance with the name of signer, date and time of signing, and the reason for signing
11.50(b)Are these signatures in human-readable format
11.10(b)The ability to generate accurate and complete copies of records in both human-readable and electronic form suitable for inspection, review, and copying by the agency. People should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.
11.10(c)Protection of records to enable their accurate and ready retrieval throughout the records retention period.
11.10(d)Limiting system access to authorized individuals.
11.10(e)Record a computer-generated timestamped audit trail
11.10(f)Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
11.10(g)Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.
11.10(i)Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.
11.10(j)The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, to deter record and signature falsification.
11.10(k)Use of appropriate controls over systems documentation including:
(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.
11.70Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.

Concluding Thoughts

Check out Cygnature and stay worry-free from compliance complexities. Focus on building your business and let us take care of 21 CFR part 11 compliance. Book a demo with us today!

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