Pharma & Chemical

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:

• Concerning the regulations and standards of logistic processes and related information systems
• Batch traceability
• Efficiency of the entire work flow, thanks to flexible and precise processes aimed at maximising productivity and limiting costs
• Real-time access to participants of accurate and up-to the minute information
• Management of accont books
• Management of replacement items
• Integration with complex automated warehouses

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:

• Continuity of service and reliability, without suspensions
• Compliance with pick up cutoff, execution and delivery depending on distribution channel, customer and equipment
• Syncrhronization of the pick up processens and consolidation orders to meet the scheduled time of departure of deliveries to pharmacies, while respecting the different logistics variables, the geographical locations, the opening hours and the frequency of delivery required by the customer
• Management of different processes by distribution channel (pharmacies, hospitals,...)
• Management and pick up of unsaleabel parcels

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:

• Control of user access (UserID, Password, User profile)
• Selective control of operational functions and user role definition
• Management of electronic signatures
• Controlled access to GMP sensitive data
• Automatic audit trail for operations that involve GMP sensitive data
• Archiving, exporting and printing of electronic records (ER)
• Documentation on use of system
• Procedures for Change Control, Backup & Restore, System Maintenance and Data Archiving

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.