#1 CHALLENGE
The client, a research-driven pharmaceutical company and global market leader with its product, faced a series of routine audits conducted by the relevant regulatory authorities. Within just a few weeks, routine audits and inspections with various focal points were scheduled to take place at multiple locations, with a constant focus on the validation of SAP ERP systems.
To ensure a positive outcome despite the high volume and rapid succession of audits while minimizing disruption to internal business operations, the company opted for professional audit support.
Expertise
#2 APPROACH
msg industry advisors supported the client throughout the entire audit process and developed a comprehensive project plan in coordination with the local teams to effectively defend the various audit areas.
The audit preparation was preceded by an analysis phase, during which the project team assessed the quality management system, Standard Operating Procedures (SOPs), and their implementation. Recommendations were classified into Quick Wins and Long-Term Gains. Additionally, outstanding deviations and CAPAs (Corrective and Preventive Actions) were resolved to eliminate potential vulnerabilities. Following the analysis, subprojects were initiated to optimize documentation, clarify inconsistencies, prepare the client team through training sessions and mock audits, establish a back-office support system, and cover all contingencies.
Key Facts
- 8 experts
- 9 months project duration
- 20 workshops
- 60+ interviews
#3 OUTCOME
The intensive audit preparation and support provided by msg industry advisors enabled the client to achieve audit readiness in record time while continuing daily operations without disruptions.
A key factor in ensuring a smooth process was the systematic pre-analysis, which allowed potential findings to be identified and addressed early on. Additionally, the established back-office support system facilitated seamless communication and document management during the audit. A structured ticketing system ensured that all relevant information was recorded and documented efficiently.
#4 OUR IMPACT
Where msg industry advisors make the difference:
- Targeted and efficient audit preparation through a powerful framework for assessing the maturity of the existing pharmaceutical compliance landscape
- End-to-end support throughout the entire audit process, involving local teams to ensure long-term compliance conformity
- In-depth knowledge of specific compliance requirements across various regulatory environments and hands-on experience from numerous audit situations