At every step taken to design an artwork it could be introduced a “human error”. In order to avoid this error, we come into play.
Patient safety goes hand in hand with the medicine quality.
The information that the patient reads on the medicines packaging must come from a validated and strong process ensuring its accuracy.
Thanks to the experience we have acquired in our 10 years activity, we can be a valid support for the company to strengthen their safety in quality control through automatic proofreading systems, in order to assure to their customer the accuracy of all information on the packaging.
WHAT CAN WE DO FOR YOU?
- Text File Inspection
- Graphic File Inspection (PDF-PDF)
- Printed Material Inspection
- Braille Inspection
- Color Inspection
- Barcode and Datamatrix Inspection
- Anti-Counterfeiting and Traceability Systems
TO WHAT COULD IT BE APPLIED?
- Flexible Packaging Material
COMPLIANCE AND VALIDATION
In 1997 FDA released the final version of 21 CFR Part 11 regulations.
The regulation provides organizations with the structure for the production, memorization and assurance of safe access to electronic data.
The purpose of the provision includes any area where paper documents are required.
21 CFR Part 11 is applicable if such procedures, signatures and paper storage techniques must be replaced with an electronic filing system based on computer. The arrangement includes rules regarding copying, audit trail, control versions, access control and signatures of electronic documents saved and made for the purpose of compliance.
According to the content of this document, FDA guidelines state that 21 CFR Part 11 is not relevant whether physical data are maintained, including computer-generated printed reports and documents that are signed and stored.
Compliance with 21 CFR Part 11 requires both the procedural requirements and software requirements. The procedural requirements include the validation of the system of electronic tracks, drafting and operational procedures for the use of the electronic filing system, that at the same time ensure that users of electronic data have received proper training on how to use and manage correctly those data.
AMD Electronic through its qualified staff offers the following additional services as part of the installation of the systems of Proof Reading and Artwork Management:
For pharmaceutical customers, we offer a complete validation, from the documentation phase to the validation execution phase.
From the training sessions via the web to those carried out at the customer site, our training programs aimed at the development of a qualified and experienced user.
Our international presence and company size allows us to offer services of full support: technical support online, by phone, by e-mail, product updates and personalized visits to customer site.