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Gathering a new supplier's complete documentation before an upcoming audit – GMP certificates, audit reports, quality agreements, change management protocols – from various Excel spreadsheets, email threads, and shared folders. It's time-consuming and carries countless opportunities for error.
Procurement work has grown beyond managing supplier relationships in recent years: it has become a coordination center where cost-effectiveness, supply security, and GxP compliance must be guaranteed simultaneously. However, the tools that should solve this were developed years ago, for a simpler environment.
Nearshoring in the pharmaceutical sector has accelerated in recent years. Hungary, Poland, and the Czech Republic play an increasing role not only in production but also in supplier networks. Shorter delivery routes, more flexible communication, faster response capabilities – a commercially attractive combination. IQVIA Market Insights reports also confirm that the stability of regional supply chains has become a key issue in reducing global exposure.
However, this presents new challenges in procurement work. Qualifying a Western European partner that has been operating for decades is a routine task: references are available, the audit history is documented, GxP processes are well-established. For a regional supplier founded just a few years ago, these are missing. The documentation background must essentially be built from scratch, while qualification requirements remain unchanged.
Risks come with measurable costs. Production downtime due to an inadequate supplier can mean losses of tens of millions of forints per day. A documentation deficiency during an audit can be a Critical Observation, which jeopardizes the manufacturing license.
Every country in the Central and Eastern European region applies different documentation, pricing, and approval requirements. Although the EMA harmonizes the framework rules, national authorities have their own jurisdiction in certain areas.
In Hungary, for example, the specific documentation and professional requirements of the National Public Health and Pharmacy Center (NNGYK) must be followed during domestic manufacturing and distribution processes. In Poland, approval documents have different formats, while in the Czech Republic, the approval process has a different hierarchy.
Large enterprise ERP systems support standardized, global processes. In a significant number of cases, local specifications cannot be handled within the system. The consequence: spreadsheets for unique cases, email-based approvals for special requests, manual documentation for country-specific requirements.
When an audit is prepared, the complete documentation chain must be assembled from different sources, which represents a significant administrative burden.
According to ISPE GAMP 5 guidelines, spreadsheets can be used in a validated environment, but under strict regulations. In practice, many companies operate with manually managed systems that do not meet FDA 21 CFR Part 11 or EU GMP Annex 11 requirements regarding electronic signatures and traceability – during an audit, this can be classified as a serious regulatory deficiency.
In concrete workflow terms, this means:
This is a consequence of the limitations of available tools.
A supplier onboarding project takes two weeks on paper, but in practice, the QA team spends 3 weeks reviewing documentation and identifying gaps. The legal department works with a 2-week response time on contractual issues, and finance often requires renegotiation on pricing matters. For the IT department, data entry into the system gets delayed.
All of this can mean a total lead time of 6-8 weeks. The procurement professional is responsible for coordinating the project but has no direct influence on the capacity of other functional areas. Process slowdowns often reflect on the procurement function, although the delay stems from structural causes.
Procurement professionals' performance is typically measured by cost reduction. In the pharmaceutical industry, however, value creation also appears in other dimensions.
What is measurable: annual cost reduction percentage, procurement price optimization, tender process speed, supplier performance improvement.
What is difficult to see: prevention of production downtime, identification of potential compliance risks, continuous provision of audit-ready documentation, continuity of supply in crisis situations.
This is the Total Cost of Ownership (TCO) approach. In the pharmaceutical industry, the cost of a stoppage due to a raw material supply problem or a regulatory deviation far exceeds the savings achievable through optimized procurement prices by orders of magnitude.
How can the value created by preventing a problem be documented?
International competitors work with integrated systems: processes are automated, audit trails are automatically generated, documentation is centrally up-to-date in real time. In contrast, many domestic organizations operate with fragmented, manual solutions.
10-15 year ERP contracts and closed systems limit the integration of new technologies, slow down processes, and increase both the time requirements of work and compliance risk.
The technological difference accumulates over time. At some point, it's no longer a question of money, but of time: how long does it take to catch up with organizations that already work with modernized systems?
A structured audit of current procurement and quality assurance processes relative to GxP requirements. Which processes operate manually? Where is the audit trail missing? Which documents are not stored centrally?
Integration of spreadsheets, email-based approvals, and manual records into a centralized system. This is not just a technological change, but also means standardization of processes and improvement of cross-functional collaboration.
The essence of the Software with Service model is that continuous professional and validation support accompanies the technology platform. This way, the procurement team does not struggle alone with the system change and GxP compliance burdens – the platform provides automated workflows, while the expert background guarantees that the system follows the changing regulatory environment.
The work of procurement professionals is becoming increasingly complex, while the supplier market is changing and regulatory expectations are tightening. Organizations that modernize procurement and quality assurance processes work more efficiently, with lower operational risk and higher compliance levels.
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