Success case – Alkaloid

Alkaloid from Skopje, North Macedonia, Europe

History

Alkaloid AD is a company with more than eight decades of experience, operating in the field of manufacturing of drugs, cosmetics, and chemical products.

Alkaloid AD is a joint stock company that consists of two revenue areas: Pharmaceuticals and Chemicals, Cosmetics and Botanicals.

There are two subsidiaries located in the country, as well as 18 subsidiaries and 2 representative offices internationally (Serbia, Montenegro, Kosovo, Albania, Bosnia and Herzegovina, Croatia, Slovenia, Switzerland, Bulgaria, Turkey, Ukraine, the Russian Federation, the USA, and the UK).

The company has 1,860 employees in the country and 560 employees in subsidiaries and representative offices internationally.

Client challenge

Validation of migration from ERP SAP ECC 6.0 to SAP S/4 HANA and the integration with other two solutions (Central Weighing Solution and Serialization Solution) to comply to the European GMP and FDA 21 CFR PART 11. To upgrade and validate the migration in six different subsidiaries in various, different countries, besides that, its validation partner (i.e., FIVE Validation) is based in another country and in a different time zone.

The solution

Validation was supported by GO!FIVE™’s library of templates and FIVE’s team experience. These library templates are composed of requirements, risk scenarios and test items, that helped and accelerated the process for them.

There were discussions in collaboration with the Alkaloid validation team about the system and processes due to the idiosyncrasies and complexity of this project. The Alkaloid team consisted of eighteen members covering all teams and functions.

Regardless of different time zones, GO!FIVE™, a quality testing software, was and still is available, 24/7. This allowed the online management of the validation progress which everyone could work at their most optimal time and prioritize activities.

Discussion meetings took place within ours and Alkaloid’s common working hours. Those activities that did not need to be done together took place outside of those hours.

In this challenge, Alkaloid had the support of FIVE Validation in the elaboration of the Validation Plan, User Requirement Specification, the elaboration and joint discussions for the Functional Risk Assessment phase, the elaboration of IQ, OQ and PQ test protocols and the Traceability Matrix.

Client Benefits

Validation occurred in 6 months benefiting six different group companies. Validation was 100% remote avoiding the need to travel and its expense.

‘The GO!FIVE™ platform is easy to use, documents are easily accessed’ — Mila Palamidovska, IT, Alkaloid AD

‘The remote validation with FIVE was quite a rewarding experience all together’ —Darko Atanasoski, QA Validation, Alkaloid AD

‘The partnership proved to be a complete success’ — Nikola Dimovski, IT Director, Alkaloid AD