AMD ELECTRONIC SRL - PROOFREADING SYSTEMS FOR FOOD INDUSTRY
In all stages of designing an artwork which can be introduced the "human error", at that precise point we begin our work with proofreading systems for food industry.
Patient safety goes hand in hand with the quality of the medicine.
WHAT CAN 'DO FOR YOU A.M.D. ELECTRIC?
Inspection text file
Inspection graphic files (PDF-PDF)
Printed Material Inspection
Braille Inspection
Color inspection
Inspection Barcode and Datamatrix
Anti systems to traceability
WHAT CAN 'APPLY?
Illustrative leaflets
Labels
Cases
Aluminums
Material from Flexible Packaging
COMPLIANCE AND VALIDATION
In 1997 the FDA issued the final version of the regulation 21 CFR Part 11.
The regulation provides the framework by which organizations are able to produce, store and provide secure access to data elettronici.Lo purpose of the provision includes any area where required documentation cartacee.CFR 21 Part 11 is applicable if such procedures, signatures and storage techniques paper must be replaced with an electronic filing system based on computer. The arrangement includes rules regarding the copy, the audit trails, version control, access control and signatures of electronic documents
are saved and made for the purpose of compliance.Stando to the text of the document, the FDA guidelines state that 21 CFR Part 11 is not relevant in the case are maintained physical data, including printed reports generated on computers and documents that are signed and stored.
Compliance with 21 CFR Part 11 involves both procedural requirements and requirements software.I procedural requirements include the validation of the system of electronic tracks, drafting and operational procedures for the use of the electronic filing system and that at the same time ensuring that users electronic data have received proper instruction about the use and appropriate management.
AMD Electronic through its qualified staff offers the following additional services as part of the installation of the proofreading systems for food industry and Artwork Management:
VALIDATION
For pharmaceutical customers, we offer full-service validation, the documentation phase to run the same validation.
TRAINING
From the training sessions performed via web to those carried out at the customer site, our training programs aimed at the development of a user qualified and experienced.
TECHNICAL ASSISTANCE
Our international presence and our company allows us to offer services
Full service: technical support online, by phone, by e-mail, via product updates and personalized visits to the customer site.