Validation of a cloud system in a regulated environment
In regulated pharmaceutical environments, informatic systems, including systems in Cloud, must comply with 21 CFR Part 11 and EU cGMP Annex 11. SherpaPharma is completely and thoroughly validated according to these rules, and guidelines such as US FDA Guidance for Industry Quality Systems, US FDA Guidance for Industry Process Validation, US FDA General Principles of Software Validation, US FDA Guidance for Industry Part 11 Scope and Application, PICS/S Annex 11, and GAMP5.
The SherpaPharma system consists of three main environments: Integration, Test or Pre-production, and Production.
Integration of a cloud system in a regulated environment
The Integration environment is used by the validation team to internally test the new developments as they become available. Clients have access to the Pre-production environment to train new users and to check the new functionalities before they are uploaded to the Production environment. In this environment is where the validation team performs the GxP validation of the new software versions. Lastly, the production environment contains the GxP data of all the clients and it is used for their daily operations. These three environments are completely separated and do not share any data.
Tiselab carries out a full validation life cycle to test all SherpaPharma system’s functions and their reliability.
- The first step the Tiselab team does is exhaustively verify all new developments prior to their upload.
- When enough new features have been added, a Change Control is opened, and a new version is uploaded to the test system.
- Then, the validation process starts following the GAMP5 life cycle and according to our internal SOPs such as Risk Analysis Procedure and Validation Policy Standard.
- Afterward, all necessary documents are issued: Release Notes (which is immediately sent to all clients, so they are aware of the changes that have been introduced), Validation Plan, User Requirements, Functional Specifications, Configuration and Design Specifications, Risk Analysis, Installation Qualification, and Operational Qualification.
Test or Pre-producción of a cloud system in a regulated environment
Based on all of these documents, the testing of the Pre-production system is performed. This phase takes place in the Test environment so clients, who work in the Production system, can continue with their usual process in a fully validated environment. This allows for the training to take place before the new features are uploaded to the Production environment. After the training that Tiselab offers and each client’s evaluation of which developments affect their operation, a Product qualification should be carried out. This step is each customer’s responsibility but Tiselab is always available to assist whenever it may be necessary.
As soon as all the testing is successfully completed, the Traceability Matrix and the Validation Report are issued.
With the QA’s approval, and after notifying all clients, the new version is released into the Production system. This upload is instantaneous and no further validation, other than the environment comparison, is needed. This implies that as soon as the version is available all client’s can continue with their operation. For on-premises systems, this whole process including installation and validation of every new version has an impact on the client’s efforts, time and costs. But since SherpaPharma is a Cloud system, the upload of the version is carried out by Tiselab on the timetable that has the least impact on the users using the system. Once the whole cycle is finished, all validation documents are sent to all customers at no extra charge since it is included in the annual license.
All in all, the whole process ensures that SherpaPharma is a fully validated solution compliant with all the current regulations. Following Tiselab’s value to inspire trust, the client always has all documentation and internal SOPs available which, combined with a personalised support, ensure that they can have a full outlook of the software. The fact that the full validation is performed by Tiselab is not only timesaving for the users but also allows them to mainly focus on their operation. Altogether make SherpaPharma a great tool for reliable and effective environmental monitoring.