FDA Regulations


Implementing FDA 21 CFR Part 11 software systems is critical for organizations to comply with the FDA as well as to become more efficient and productive. FDA-regulated organizations need to choose the right quality management system (QMS) to not only meet compliance, improve quality, speed of doing business, but one that can be adapted to their unique business process needs.

Intellect’s solutions are designed for organizations to meet FDA 21 CFR 11 compliance and beyond by streamlining and automating quality management, document control, product lifecycle management and business process management unique to your environment. Intellect’s platform is highly flexible and agile, allowing your organization to enforce the standardization that makes sense for your organization.

Achieving Part 11 Compliance with Intellect

Part 11 Section 11.10 requires an assurance of the authenticity of electronic records.

Intellect allows system administrators to provide user permissions for every task, document, and even down to a single field. Intellect also creates an audit trail of any captured document, including version control with a history of authorship changes and approvals.

Part 11 Section 11.10 also requires that the possibility that a signer would repudiate an approval be minimized.

Intellect’s system can be set-up to require users to enter two passwords to approve any type of document collaboration or task. The first password is the login password and the second password is an approval password.

Part 11 Section 11.10a requires the validation of the electronic system.

Intellect has developed tools, solutions, and services that can reduce the effort of software validation.

Part 11 Section 11.10i requires that all those who have been approved to use the electronic system are trained to perform assigned duties.

Intellect offers training management that is automatically triggered when an essential quality document is revised to ensure sustained FDA 21 CFR Part 11 requirements. Intellect also automates follow-ups, notifications, and escalations of past-due training and creates an audit trail of all training data and certifications.

Part 11 Section 11.10k requires document controls that provide revision controls, change controls, and time-based system modifications.

Intellect offers all of these document control features and more.

Part 11 Section 11.50a requires signed electronic records with the following data: name, date/time of signing, and meaning of signature.

Intellect provides fields for all required information to ensure FDA 21 CFR Part 11 compliance and for additional information if additional fields are desired by the user.

Part 11 Section 11.70 requires the linking of electronic (and handwritten) signatures to their corresponding electronic records.

Intellect can automatically link every signature to a specified record.
Learn more about how Intellect software solutions helps you attain FDA CFR compliance.


The FDA issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule FDA CFR Part 111 in 2007, requiring proper controls be in place for dietary supplements during manufacturing, testing, quality control, packaging, labeling, holding operations, and distribution. This ruling ensures that dietary supplements disclose an accurate listing of supplemental ingredients, and applies to all domestic and international manufacturers.

Intellect works closely with health and life sciences and other regulated industries to provide a highly flexible, configurable, and integrated system to help organizations comply with FDA regulations, including FDA 21 CFR Part 111.

FDA 21 CFR PART 210-211

Since 1962, the FDA that all drugs be produced according to Good Manufacturing Practice (GMP) and this should be in compliance with FDA 21 CFR Part 210-211. Later, the word “current” was added to make it “CGMP” or “cGMP” to signify that the regulation allows for changing technology to attain GMP.

FDA 21 CFR Part 210-211 contains the minimum CGMP for methods to be used in the manufacture, processing, packaging, and holding of drugs to ensure they meet compliance and regulatory requirements, ensuring the safety, quality, and purity of drug products.


21 CFR 606 provides the Current Good Manufacturing Practice (CGMP) requirements for blood banks, labs, and blood-related establishments to ensure that blood for human use are safe, pure, and effective. Blood establishments must meet process and production controls, equipment regulations, and quality assurance requirements found in CFR 21 Part 11 as specified by the Center for Biologics Evaluation and Research (CBER) compliance programs.


Medical Device Manufacturers must meet FDA 21 CFR 820 compliance, also known as Quality System Regulation (QSR) requirements. QSR outlines Current Good Manufacturing Practice (CGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. Medical device manufacturers undergo FDA inspections to ensure FDA 21 CFR 820 compliance, and these requirements are meant to ensure that medical devices are safe and effective.

FDA 21 CFR PART 1270-1271

Medical organizations and laboratories must comply with 21 CFR 1270-1271 for Good Tissue Practices (GTPs) for blood and biologics. Human cell, tissue, and cellular and tissue-based products (HCT/Ps) are critical in cardiac surgery, reconstructive surgery, and other medical surgeries and procedures. The FDA protects the HCT/P supply by enforcing the Good Tissue Practice (GTP) requirements in 21 CFR Part 1270 and 21 CFR Part 1271, and thereby ensuring safety of HCT/Ps by preventing the introduction, transmission, and spread of communicable disease.

Automate and streamline the routing, approval, escalation, and revision of documentation based on your unique process needs by using Intellect’s highly flexible software solution. Create powerful reports to help with decision-making, and custom dashboards allow you to monitor processes in real time. At the same time, Intellect’s system provides an audit trail of all changes, including identifying who made the changes, who approved them, and any other unique requirements.

Intellect can help to comply with Good Tissue Practice (GTP) compliance, and to meet the requirements under 21 CFR Part 1270 and 21 CFR Part 1271.