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.
Part 11 Section 11.10 requires an assurance of the authenticity of electronic records.
Part 11 Section 11.10 also requires that the possibility that a signer would repudiate an approval be minimized.
Part 11 Section 11.10a requires the validation of the electronic system.
Part 11 Section 11.10i requires that all those who have been approved to use the electronic system are trained to perform assigned duties.
Part 11 Section 11.10k requires document controls that provide revision controls, change controls and time-based system modifications.
Part 11 Section 11.50a requires signed electronic records with the following data: name, date/time of signing, and meaning of signature.
Part 11 Section 11.70 requires the linking of electronic (and handwritten) signatures to their corresponding electronic records.
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.
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.
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 the identity who made the changes, who approved it and any other unique requirement.
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.
Give Intellect a try today and see what it can do for your business.