Current standards in the pharmaceutical industry are becoming increasingly stringent. They aim to guarantee the product quality and the process safety, in order to counteract the risk of fraud and the spread of illegal distribution channels.
Tough competition between different companies and the strong economic pressure, require a very careful management of operational logistics.
Click Reply™ for Pharma answers the industry’s most common needs and problems:
Experience gained in the industry makes Click Reply a valid partner in the process of defining system requirements and in the management of the overall implementation of the information system, keeping in line with the methods required by certifying bodies.
The solution is ideal for the management of both logistics and critical aspects that characterize the distribution of medicine - context in whick the stock of the "sale point" is reduced and the restock are more frequent - such as:
Click Reply™ for Pharma is FDA compliant both with regards to the conservation and archiving of documents in electronic format, particularly concerning 21 CFR part 11 on the handling of electronic signatures. The system adheres to GAMP4 which acts as a guide, and provides models for, the development of automated systems and the maintenance of their conformance and validation status.
In particular, Click Reply™ for Pharma is FDA compliant because it allows:
A wide set of product attributes such as batch, loading date, production date, expiry date, title, basic specifications, picking tolerance, status of material (good, expired, in QC, in quarantine). The system records any data changes, allowing complete traceability of batches, both in terms of product and components, and provides assistance for managing status changes due to temporal events.