AIS have experience in implementing software solutions that have the necessary tools to allow compliance with the requirements outlined by Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures.
The guidelines outline requirements for security controls, systems validation, documentation and audit trails for any electronic systems that are used to handle data which is legally required by FDA regulations. The requirements apply mainly to operators within the Life Science Industries including medical device manufacturers, pharmaceutical producers and biotechnology companies.
Our Label Inspection and Barcode Verification products, along with the Label Design Software packages we supply, come with built-in 21 CFR Part 11 compliant ready tools. If you have any questions about 21 CFR Part 11 compliance, please call us on +353 (0)1 6205742 to discuss.
White Paper: NiceLabel 21 CFR Part 11 Compliance Assessment
Drug and medical device manufacturers as well as companies in other FDA regulated industries are required to provide electronic
records and signatures as a reliable equivalent to paper records. This white paper examines the FDA and EU regulatory standards and outlines how NiceLabel solutions ensure proper label life cycle compliance. You will learn how NiceLabel integrates the labelling required for life sciences regulations with customers’ existing workflows and business information systems including Oracle, SAP, or another ERP system.
