Freya Wolles Business Development Manager Q +32 496 77 45 14

Tramedico

A validated ERP, without security loopholes

Several guidelines impose high standards for the ERP system of pharmaceutical company Tramedico. R&D, production, storage and distribution must comply with strict international rules. Ordina integrated strict validation processes into the new ERP system of this SME. The system now offers principals and customers the assurance that the necessary quality requirements will be met.

Tramedico Contact Contact Freya Wolles

customer

Tramedico is the trusted partner of internationally respected pharmaceutical companies. Tramedico monitors for its partners the interests of prescription drugs in the Benelux countries. As an  independent company, Tramedico focuses mainly on niches in the pharmaceutical market where specialization plays a major role: gastroenterology (stomach, intestines and liver), ophthalmology and rheumatology.

challenge

Medicines must be pure, safe and efficacious. To guarantee high quality, a pharmaceutical company must operate according to the principles of GMP, GSP and GDP: good manufacturing, good storage and good distribution practices. These principles state that a pharmaceutical company must document and conduct R&D, production, storage and distribution processes accurately. When Tramedico shifted its focus in 2006 from manufacturing to sales and distribution, the company went looking for a new ERP system. It chose Navision. The high quality requirements associated with GMP require quite a number of guidelines to be embedded in the system. Tramedico was therefore seeking a partner who could integrate the necessary validation processes, and found that at Ordina.

solution

Ordina gave thorough consideration from the outset to both the validation master plan and the details of the approach. It deliberately used a risk-based approach. The greater the risk and the impact of the systems on patient safety, product quality and data integrity, the greater the validation effort. Together with Tramedico, Ordina built a matrix that linked five hundred user requirements to functional specifications and qualifications for the ERP system. Ordina thus created clarity in the internal discussion about how Tramedico should tackle the validation challenge.

result

Ordina's risk-based approach increased the efficiency of the validation processes and cut costs. All guidelines on GMP, GSP and GDP are now embedded in the Tramedico system, while the processes were thoroughly documented. This provides the company with a fully validated computer system, which prevents a lot of problems in inspection and audits. The new system offers principals and customers security. Moreover, the change control procedures ensure that the system remains validated even after the completion of the validation report. Management of manuals and processes is now centralized and the procedures are clearly laid down. This ensured that staff are now better trained and are aware of the importance of the validation processes.