GxPharmaCloud is a private cloud solution located in one of the most secure datacenters in Spain and holds the TIER IV GOLD certification.
GxPharmaCloud is specifically designed for the pharmaceutical industry and medical devices, offering qualified services so you can host your systems while complying with regulatory requirements. This ensures that your systems are covered at the infrastructure level for compliance with EU GMP Annex 11 and ISO 13485 standards, without you having to make any effort.
GxPharmaCloud is also oriented toward suppliers in the sector who have applications that must be used in SaaS mode, ensuring that the supporting infrastructure is validated and helping these companies focus on their software rather than the IT infrastructure it runs on. In addition, traceability of requests, escalation, and incident and change management is ensured.
GxPharmaCloud has a quality system aligned with the sector that is fully open to audits by clients and regulatory agencies. This means that all necessary documentation is provided to clients so they are covered against audits in this area.
In a sector with heavy regulatory compliance that varies dynamically over time, GxPharmaCloud offers an ideal alternative to increase profitability and improve business performance.
Let's look at five key aspects of this application to discover why it is ideal for your business.
Regulatory compliance and current legislation are fundamental in the pharmaceutical sector, as their objective is to guarantee the safety and efficacy of products and protect public health. The pharmaceutical and medical device industry is highly regulated and subject to a series of laws and regulations establishing quality and safety standards for medicines and related products.
With GxPharmaCloud we ensure that clients hosting their systems in it will be covered without any effort on the client's part, since we take care of such compliance, delivering all necessary documentation that proves it.
GxPharmaCloud is a solution specially designed to make it easier for companies in the sector to follow international standards and best practices, ensuring the business complies with demanding legislation and current regulations regarding quality, safety, and the processing of personal and sensitive data.
GxPharmacloud complies with GDPR requirements. This process is carried out periodically and can also be audited.
Traceability in the pharmaceutical sector refers to the process of tracking a pharmaceutical product throughout its lifecycle, from manufacturing, through various distribution channels, to final consumption by the patient.
This is a crucial process within the pharmaceutical sector to guarantee the quality and safety of medicines and products, as well as to prevent falsification and the black market for medicines.
The quality system supporting GxPharmaCloud ensures alignment with the regulated sector in terms of data integrity. The environment operates as if it were the most rigorous IT production plant, ensuring data integrity.
Currently, the industry cannot afford intermittent shutdowns of its systems due to deficiency or low robustness of infrastructure such as power supply, air conditioning, etc.
GxPharmaCloud features an Active-Active architecture, with real-time replication across two datacenters, ensuring uninterrupted business continuity. It features redundant communication lines with different providers that minimize downtime.
Furthermore, this solution for companies in the regulated sector offers a 24/7 service, meaning it guarantees your access at all times by betting on modern and efficient IT infrastructures, backup systems (copies of security), and disaster recovery (disaster recovery, such as floods, fire, power outages...).
There is increasing talk of QA and IT departments that each must meet their own needs, making dialogue between them difficult in some cases due to differences in training in their professional careers.
GxPharmacloud has a multidisciplinary team that understands any language or departmental need to ensure that what the client needs is delivered at all times with the maximum guarantees of regulatory compliance. This helps clients have different interlocutors from different departments, with each of them obtaining what they expect.
In addition, our quality system is governed by an independent quality team that ensures operations and infrastructure are operated as established in the procedures.
Both the pharmaceutical industry and medical devices must comply with regulatory requirements, but we must not forget that application providers who want to provide SaaS services for these environments must comply in the same way.
GxPharmaCloud ensures both the industry and providers that they will comply with regulation in the scope of services provided, contributing all necessary documentation and allowing them to focus on their activities and let Gxpharmacloud comply for them.
In addition, it holds ISO27001 and ISO9001 certifications and is GDPR compliant, which ensure the protection of information and sensitive personal data in the cloud, something fundamental to operate within the framework established by personal data protection laws (such as the European GDPR regulation and Spanish LOPD law).