Management Information Systems > Print and Label Management Solutions

Print and Label Management Solutions

ITS offers print and label management solutions to improve the control, management and printing of labels for pharmaceutical, medical device and other highly regulated industries. The solutions are fully validated by ITS’ team and designed to meet GMP, data integrity and MHRA and FDA regulatory requirements.

The print and label management software solutions are easy to use and compatible with a range of printers including label, laser and sheet printers. ITS’ team has extensive experience in specifying label printers, and as a result, we can recommend the best printers to meet each client’s requirements.

Within the print and label solutions, role-based access control (RBAC) regulates access to documents and resources based on the roles of individual users. The RBAC functionality can be integrated with Windows Active Directory authentication. The solutions can be configured to offer users the access to specific software features (e.g. label design, manual printing) and documents (label templates) that they need. A full audit trail of actions is recorded in a 21 CFR Part 11 compliant database for reporting purposes.

The label Document Management System (DMS), a HTML5 web application stores all documents in a centralised database. The solutions offer a browser-based user interface that enables enterprise access and faster design and approval workflows without the need to install or maintain any software on local workstations.

The solutions provide version control for all of the labels and allows variable data to be manually or automatically added from a secure and compliant database.

ITS’ solutions can include any of the following services and systems:

  • Production of Print and Label Management User Requirement Specifications
  • Integration with ERP or database(s) to receive associated serialisation/UDI/label data
  • Configuration and implementation of a proven print and label management solution offering label approval control, full audit trail and archiving
  • Design and implementation of vision systems and code readers to verify that any data printed on each label is eligible and correct
  • 21 CFR Part 11 and CFR Part 820 compliant solution to record the traceability data applied to each product for each batch for reporting purposes
  • Validation services for print and label management solutions
  • Provision of print and label management consultancy
  • Integration of print and label management solutions with production systems e.g. OEE, situational awareness to improve operational performance

ITS’ team has been working in highly regulated industries since the company started in 1991. We have extensive experience in offering fully validated automated solutions to improve product quality, traceability, print and label management, serialisation and UDI compliance. ITS’ solutions are flexible and can be integrated with different ERP systems to automatically receive data.

The solutions can improve product quality by automatically inspecting labels and accurately tracking pharmaceutical and medical devices throughout the entire production process. The print and label management systems ensure that the label design and data applied to each batch of pharmaceuticals, devices or products is correct. As an independent company, ITS works closely with its customer base to understand their print and label management requirements and recommend the best solutions to help them achieve regulatory compliance.



Contact our team today

For further information, please contact
our team on +44 (0)1642 222232 or
email enquiries@its-ltd.co.uk