The problem – the task of transitioning the Kiara Health manufacturing site from the Sandoz SA (Novartis) systems, was a mammoth undertaking. Were it not for the expertise, agility and professionalism of the Kiara Health team, the software engineers from the U.S. based Waters Corporation (their local service provider being Microsep) and the IT technicians at Datacentrix, this project – which may have taken years to perfect – was completed in 3 months (including the festive season break and the presence of the pandemic to limit physical interaction required).
A core Kiara Health value is Quality. To ensure that this key value was maintained at the Quality Assurance (QA) and Quality Control (QC) levels of the business, the company invested in the world-leading Empower™ 3 Chromatography Data System by Waters. The Empower™ 3 Chromatography Data System is Waters’ compliance-ready chromatography data software (CDS) for advanced data acquisition, processing, and reporting that simplifies the management of chromatography test results. In the pharmaceutical manufacturing space, the software controls the HPLC (High Pressure Liquid Chromatography) systems used for the analyses of products, raw material, and active pharmaceutical ingredients (API). Furthermore, the data obtained from these analyses is converted to results, reports and must be securely stored. An integral part of the process is the maintenance of data integrity, as the data reports are used for the release of product to the market, and raw material or API for product manufacturing.
Leading the system integration project from the Kiara Health team, was Santa Cook, QA for QC and Data Integrity (DI) Officer, who previously had the opportunity to work on a global deployment programme of the Empower™ 3 software.
Due to time constraints and the need for business continuity, the initial installation and validation of the Empower™ 3 software, was via a Native Oracle server. This initial project phase took 4 weeks, including full documentation and on-site analysts’ training. However, the end goal, was to migrate to a secure AWS (Amazon Web Services) Cloud-based platform.
This second phase of the project involved building a test server – which did not come without gremlins. Instrumentation connectivity issues, low performance speed, and what was of greatest concern, the proposal of shared logons presented as critical concerns. From a QA/ QC compliance risk perspective, the latter issue was a deal-breaker. The project could not proceed as this potential risk for a security breach, posed a major threat to data integrity.
The collaborative triad (Kiara Health, Microsep and Datacentrix) engaged relentlessly with the Waters Corporation in the U.S. until risk mitigating solutions were agreed upon to address these performance and compliance issues. Once the solutions were implemented, all aspects of the system were thoroughly tested by the Kiara Heath team and the Microsep Service Engineer, Dewald Faber, until all expectations for a smooth operation were met. Full scale validation was performed as per regulatory requirements – with guidance and oversight from the Kiara Health QA department. The system was officially released to the AWS Cloud server on 25 January 2021.
The outcome – Kiara Health is officially the first and only customer on the African continent with a fully scaled server deployed in the AWS Cloud. This is the course of action that most companies are soon to follow, and it is a great accomplishment for Kiara Health, a pharmaceutical company with strict regulatory controls, to have pioneered this venture.