FDA 21 CFR Part 11 Training, Regulations, and Best Practices

Dr. Karim El-Khoury
FDA 21 CFR Part 11 training

FDA 21 CFR Part 11 training means understanding the various digital processes and controls and having in-depth knowledge of how cybersecurity, data privacy, and data integrity can be ensured.

The Food and Drug Administration is a US federal agency tasked with regulating and standardizing health and human services in the United States of America. It has several protocols, guidelines, and documents outlining acceptable quality controls, procedures on data operations, and all the necessary security mandates that must be taken care of when dealing with any operation, activity, or business related to healthcare and food.

The FDA is a humongous guidance material with several subparts and components, each detailing a specific procedure or operation. In that regard, the FDA 21 CFR Part 11 lays down the regulations for everything related to electronic records and electronic signatures

The FDA Code of Federal Regulations

The CFR published by the FDA contains the entire code of general and permanent regulations to be applied to the upkeep and maintenance of health departments across the United States. It is subdivided into 50 titles, among which the 21st title refers to the Food and Drug products and processes. Part 11 of 21 specifically details all the regulations on how computers and electronic systems can be used when dealing with Food and drugs data. This regulation is necessary to ensure that sensitive data is protected and only authorized access is allowed on FDA data.

These regulations also help to ensure data transparency and integrity, ensuring no fraudulent activities can occur. Since much of the world has shifted towards digital sources and computers are predominantly used for processing data, the FDA 21 CFR part 11 has become essential to managing a Food and Drug business. Anyone handling related operations must be well trained in the same.

What FDA 21 CFR Part 11 Training Deals With?

FDA 21 CFR Part 11 training means understanding the various digital processes and controls and having in-depth knowledge of how cybersecurity, data privacy, and data integrity can be ensured. Here are the major concerns of digital data  that Part 11 deals with:

  • Data authenticity

Data should be verifiable and valid and correspond to exactly what happened without errors or room for manipulation.

  • Data integrity

Data integrity refers to how reliable the data is, starting from the observation method, the data recording procedure’s validity, the qualification of the personnel collecting data, and more.

  • Data adequateness and appropriateness

This refers to the adequateness of the data collected and stored, its usability, and applicability to the problem.

  • Confidentiality of electronic records

This refers to the various data classification and access control mechanisms in place that should protect sensitive data from unauthorized access and use.

  • Data retrieval

This deals with data retrieval and retention tasks so that data retrieval must ensure accuracy at all stages, and data should not be held after the retention period.

It is important to know the differences between all the above data qualities and the necessary steps to ensure them.

The regulations covered by Part 11 affect a wide range of industries, such as:

  • Biotech
  • Drug manufacturers and dealers
  • Medical device manufacturers
  • Biological developers

Besides data regulation, Part 11 also deals with an important part of digitization, the validation of electronic signatures. Anyone dealing with e-Documents that ought to come under the FDA regulations must be well-trained to authenticate electronic signatures. This helps ensure that you are indeed dealing with valid data and thus can be protected from fraud and corrupted data.

Subparts of FDA 21 CFR Part 11

The important subparts of the Part 11 mandates are:

  • General Provisions

Deals with clinical investigations and related electronic records. FDA accepts data records of types act, biometrics, closed system, pen system, digital signatures, and handwritten signatures.

  • Electronic Records

This section provides the details on the validation, record maintenance, system access checks, workflows, document control, and personal accountability of maintaining electronic records.

  • Electronic Signatures

This section details the e-signature mandates, controls, and rules that apply to implement and validate an e-Signature

Training to audit based on FDA 21 CFR Part 11

Every data regulation by FDA 21 CFR Part 11 demands that stored data be auditable to check for inconsistencies or non-compliance. Auditing also helps weed out the root causes for any identified issues and helps establish the validity of the data system to any third party of the government agency.

Auditing is the only way to validate a company’s compliance and every company. Businesses or individuals dealing with FDA data are required to maintain a complete audit trail.

An audit trail is a document that provides the complete version history of every quality relevant document in your system and has a record of every data transaction and interaction with the system. It should be able to provide complete traceability and accountability for every single change made to your data systems.

FDA 21 CFR Part 11 Training Certification

FDA 21 CFR Part 11 Training

FDA regulations are a vast piece of documentation outlining and detailing each aspect of food and drug products, processes, and businesses. It takes great attention to detail and expert guidance to get it all right and stay compliant. But as you must know already, staying FDA compliant is essential to work in the Food and drug industry. To learn more about the FDA 21 CFR Part 11, we have compiled a comprehensive course. This online FDA 21 CFR Part 11 course has been developed by Dr. Patricia Kay, a senior research data management professional with 20+ years of experience in clinical development, stakeholder management, business unit operations, and personnel management. This 2-hour training course provides you with a certificate of completion and CEU/CPD accreditation.

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