---

PharmaStatus

Service that delivers selected information on the current status of pharmacies and wholesale distributors in Platforma Rejestrów Medycznych CSiOZ (Polish Medical Registry) by email.

PharmaStatus is a solution that provides effective notifying of:

• Pharmacies’ status changes in Polish Medical Registry,
• Wholesale distributors’ status changes in Polish Medical Registry.

The main functionality is sending .csv reports based on changes in Polish Medical Registry’s database. The reports contain information about:

• New pharmacies (applies to pharmacies that had their status changed to ‘active’),
• Deleted pharmacies (applies to pharmacies that had their status changed to ‘inactive’),
• New wholesale distributors (applies to distributors that had their status changed to ‘active’),
• Deleted wholesale distributors (applies to distributors that had their status changed to ‘inactive’).

Warehouse Management System

Our Warehouse Management System provides full support for warehouse operations. It includes all the necessary functions and our innovative solutions which improve efficiency, such as:

• Storage system – configurable storage procedures, including high stacking; storing of products compliant with the GDP guidelines,
• Product’s location automatically optimized based on sales results,
• Picking paths follow the FEFO rule,
• Intuitive work on mobile RF terminals,
• Integration with site’s automation,
• Audit trail – registry of changes made to GDP-relevant data.

Warehouse Management System is compliant with Good Distribution Practice. It is prepared for validation in compliance with GAMP 5.

Validation Management System

Our Validation Management System provides full support for actions required to complete a validation process. It includes all the necessary functions and our innovative solutions which improve efficiency of documenting and overseeing validation and qualification, such as:

• Management of items that are included in the scope of validation, including audit trail,
• Registration and oversight of User Requirements Specification (URS),
• Registration and oversight of Functional Specification (FS),
• Registration and oversight of Design Specification (DS),
• Design Qualification (DQ), compliance check of FS and DS with the URS, automatic generation of Traceability Matrix,
• Risk Assessment (RA) based on FS and DS, automatic generation of Traceability Matrix,
• Registration of IQ/OQ/PQ protocols based on RA results,
• Registration of results and documenting IQ/OQ/PQ,
• Generation of Validation Report (VR) along with Traceability Matrix,
• Version control, approving, email notifications about status of each part of validation process,
• Audit trail – registry of changes made to GxP-relevant data.

Validation Management System is compliant with Annexes 11, 15 of Good Manufacturing Practice. It is prepared for validation in compliance with GAMP 5.

Validation

Our software is compliant with Annex 11 of Good Manufacturing Practice and 21CFR part 11. Our systems come with the documentation necessary for completing the validation process – Functional Specification, Design Specification, and if needed User Requirements Specification. We also offer to carry out validation in accordance with GAMP 5 manual and Annex 15 of GMP. Apart from that we also perform validation of other computer systems, processes, transportation routes, devices and installations, as well as qualification of rooms and vehicles. We will prepare full documentation, which includes:

• Validation Plan,
• User Requirements Specification,
• Functional Specification,
• Design Specification,
• Design Qualification,
• Risk Assessment,
• Installation Qualification,
• Operational Qualification,
• Process Qualification,
• Validation Report.

As a part of validation work we perform tests and measurements based on prepared test protocols within the scope of:

• Computer system validation,
• Room qualification,
• Vehicle qualification,
• Transportation route validation,
• Process validation,
• Device and installation qualification.

To find out more, contact us!