Seidor and Syntegon Telstar promote regulatory-validated SAP Solutions for the pharmaceutical industry

The technology consulting firm SEIDOR and Syntegon Telstar have signed a collaboration agreement to offer the pharmaceutical and healthcare technology industries comprehensive SAP solutions implemented and validated in accordance with the most demanding regulatory requirements (such as EU GMP Annex 11 and FDA 21 CFR Part 11).

Through this collaboration, Telstar strengthens the competitive value of its consultancy services, especially the validation of computerized processes, to ensure regulatory compliance in critical manufacturing processes. It also enables laboratories and manufacturers in the sector to access SAP solutions developed by SEIDOR, tailored to their processes, and validated from the outset using GxP methodologies, ensuring regulatory compliance and readiness for audits and inspections.

A growing need in the regulated industry

Companies in the pharmaceutical and medical device sectors face the challenge of modernizing their management systems without compromising traceability, data integrity, or the validation required by regulatory authorities. To achieve this, it is essential that technological solutions, such as those in the SAP field, be rigorously designed, implemented, and documented in accordance with the quality and control principles defined by GxP best practices from its inception.

Integrated technology and validation

SEIDOR, as one of the leading global SAP partners, provides its experience in implementing these solutions in regulated environments, with modules specifically focused on production, quality control, traceability, document management, and regulatory compliance. Its industry expertise ensures SAP is adapted to the operational and regulatory specificities of each client, integrating regulatory requirements into all phases of the project.

For its part, Syntegon Telstar offers a comprehensive pharmaceutical consultancy service that covers the entire drug product lifecycle. Within this framework, it is responsible for the validation of computerized systems (CSV), in accordance with methodologies recognized by regulatory authorities. This process ranges from the initial risk analysis to the planning and execution of functional and safety tests, with the preparation of all necessary documentation to certify that the system meets regulatory requirements before its implementation.

Regulatory compliance and efficiency

This collaboration enables companies to gain a comprehensive and coordinated solution that combines the power of SAP with the guarantee of complete validation, helping them reduce non-compliance risks, shorten implementation times, and avoid costs associated with subsequent adaptations. This joint approach responds to the growing industry demand for robust and auditable digital solutions that accelerate transformation without compromising regulatory compliance.

Scope

This collaboration agreement begins at the national level and is expected to expand internationally in the near future.