Custom Software Solutions for Automatic Labelling
AIS have a dedicated team of highly trained software engineers with many years experience of automatic labelling applications. Our engineers have developed numerous custom applications that integrate to existing software systems, including almost all major ERP systems (SAP, MFG Pro, JD Edwards) as well as other industrial control systems.
Our solutions typically cover all aspects of the project, from design and specification, through installation and commissioning, and on into validation and support. AIS are equally at home providing a total solution or integrating with existing systems and we have numerous reference sites in a wide and varied array of labelling applications.
Our Label Inspection products, along with the Label Design Software packages we supply, come with built-in 21 CFR Part 11 compliant ready tools.
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.
If you require any additional information, please call us on +353 (0)1 6205742 to discuss your requirements.