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Digitization in compliance with 21 CFR Part 11 of the FDA

Digitizing critical data has become an imperative for Life Sciences Companies. Data security, reliability, and integrity must be strictly adhered to comply with FDA regulations.

Digitization in compliance with 21 CFR part 11 of the FDA - Life Sciences companies

Table of Contents

Digitizing critical data has become a priority for regulated companies in the life sciences industry. However, to comply with FDA regulations 21 CFR Part 11, data security, reliability, and integrity must be strictly adhered to. In addition, companies must include regulatory compliance in their digital transformation strategy to maximize the benefits of digital technology while minimizing reputational risks and regulatory penalties.

An Imperative for Life Sciences Companies – Compliance

Compliance with 21 CFR Part 11 is critical for companies looking to make a digital transformation in the life sciences space. 21 CFR Part 11 is a Food and Drug Administration (FDA) regulation that outlines the criteria that IT systems used in clinical trials, manufacturing, and distribution of pharmaceutical, biological, and medical products must meet. Compliance with 21 CFR Part 11 is essential to ensure healthcare products’ safety and effectiveness to avoid regulatory penalties and reputational risks. Therefore, companies must include 21 CFR Part 11 compliance in their digital transformation strategy to ensure regulatory compliance while maximizing the benefits of digital technology.

Digital technologies and critical data processing

Digital transformation involves using digital technologies such as data management solutions, automation systems, artificial intelligence, machine learning, apps, and more. These technologies can improve efficiency, quality, and compliance in developing and producing drugs, medical devices, and other healthcare products.
However, using digital technologies in regulated applications must meet the requirements of 21 CFR Part 11. For example, companies must implement access controls, electronic signatures, electronic records, and system validation to ensure that data is reliable, accurate, and protected against tampering.

The main requirements of FDA’s 21 CFR part 11 regulation

RequirementsDefinition of the requirementGxpManager Compliance
System validationSystem validation is the process of ensuring that the system can operate reliably and securely and produce accurate and reliable results. This involves defining the system specifications, ensuring that it is developed according to those specifications, testing the system to ensure it meets the requirements, and documenting the entire validation process.Icon representing the check sign
Access ControlsAccess controls are security measures that control access to sensitive data. This involves ensuring that only authorized individuals have access to critical data, that access levels are defined based on roles and responsibilities, and that unauthorized access is detected and reported.Icon representing the check sign
Electronic signaturesElectronic signatures are the electronic equivalent of handwritten signatures. They authenticate the author of an electronic document and guarantee that the document has not been modified since the signature. Electronic signatures must meet strict criteria to be considered valid, particularly regarding author identification, integrity control, and security.Icon representing the check sign
Electronic recordsElectronic records are electronic documents that contain information critical to the safety and effectiveness of health products. Electronic records must be maintained to ensure their integrity, reliability, and traceability and must be available for regulatory audits and inspections. In addition, records must be protected against falsification and loss of data.Icon representing the check sign
Audit trailThe audit trail is a chronological record of all activities performed on critical data. The audit trail should include information such as user identification, the action's date and time, the activity's nature, and any other relevant information. The audit trail helps track changes to critical data, detect errors and anomalies, and ensure data traceability and security.Icon representing the check sign

Digitizing critical data in full compliance

The GxpManager platform is a data management solution that enables companies regulated by FDA 21 CFR Part 11 requirements to digitize their critical data in compliance with regulatory requirements. The platform provides native access control, electronic signature, and audit trail capabilities to ensure data security, reliability, and integrity.

  • Users can access data based on their role and authorization, ensuring data confidentiality.
  • Electronic signatures guarantee the authenticity and origin of data: users can electronically sign documents with complete security and compliance, improving the efficiency of their processes.
  • The electronic recording (audit trail) allows following the modifications made to the data and guarantees their traceability and integrity.

With the GxpManager platform, companies can improve operational efficiency and regulatory compliance while enjoying the benefits of digitizing critical data.