In the pharmaceutical industry, digital transformation is necessary but also complex, given that procedures must be followed, exhaustive controls must be carried out and, above all, the responsibility of being consistent with the quality of the products must be fulfilled, since they can affect consumer health. Although this is not the only thing that conditions the change, there are also other factors that influence the digital transformation process, such as:

• System integration: The integration of different digital systems and production equipment can be a technical challenge, especially when dealing with existing systems that have not been designed to work together.
• Security and privacy: The digitization of drug production can increase the risk of cyberattacks and the exposure of confidential data, which can be especially problematic in the case of intellectual property products or clinical data of patients.
• Implementation cost: The implementation of digital technologies in drug production can be costly due to the need to acquire and maintain specialized equipment/systems.
• Maintenance and updating: Digital technology requires constant maintenance and updating to ensure optimal operation. Proper maintenance and timely updates are essential to avoid interruptions in production.

At Becolve Digital, we are aware of all the demands involved in regulated environments in pharmaceutical production, including the need to ensure the quality, repeatability and safety of production.

However, we also believe that digital transformation can improve productivity, and that is why we have developed different solutions to implement it easily and effectively.

One of them is PharmaSymphony®, a suite of pre-validated libraries based on AVEVA technology that cover different needs and will help you orchestrate the management of your production and quality in regulated environments, without compromising safety or the quality of the final product.

With Pharma Symphony You Will be Able to:

• Create, maintain and version master recipe definitions with all the details necessary to produce each of the references (MBR / Master Recipes).
• Guide the different steps to be executed in such a way as to ensure a production that scrupulously complies with the definition present in the master recipes.
• Leave a record of the execution of all the steps, of the traceability, as well as of all the parameters, events and variables of relevant GxP processes.

A Single Platform to Manage all Plant Operations.

Many of the needs related to the definition of the production process and with the set of tools to facilitate its execution and registration are usually covered by MES/MOM systems in multiple industries of different sectors.

However, not all MES/MOM systems are designed and able to meet the particularities and needs of the regulated industry.

In addition to electronic manufacturing guide and EBR management, the different features added by these Pharma Symphony libraries include:

• Management of material consumption and traceability.
• Management of the production of semi-finished and final productsManagement of the resources used, such as people, equipment or energyInteraction/integration with equipment or systems present in the plant.
• Calculation of productivity indicators or any other typeErrors and inefficiencies by doing it in an integrated way.
• Consult all the data on a single platform. Navigate through the data and turn it into information.

A System Based on Standard Market Technology and Specifically Prepared for the Regulated Industry.

Pharma Symphony® complements the technological platform of a leading company in the industrial sector globally (AVEVA), providing the sectoral elements and solutions for the regulated industry.

Thanks to this base, deployment times are reduced, standardization is achieved and risks are reduced.

The largest ecosystem of service providers at a local and international level to accompany and support in a solvent manner the current and future needs of our clients, thus maximizing the life cycle of their investment:

• Integration/automation of information flows between the guide, people and process equipment.
• Integrity of digitally recorded data following the ALCOA+ framework.
• Technological framework that allows improving productivity and safety, guaranteeing regulatory compliance (FDA, EMA, etc.)
• Pre-validated system.