Maintaining and managing legacy systems while ensuring compliance is a daunting challenge for most pharma organizations. A leading pharmaceuticals provider commissioned Sikich with a need to retire their QMS and other legacy systems (DMS and LMS) while preserving critical data for audits and regulatory requirements. Their goals were clear:
- Decommission QMS systems without losing historical data
- Maintain audit readiness for FDA and global regulatory inspections
- Integrate multiple systems into a single, secure repository
Key components and functionality delivered
ArchiveIQ® by Sikich Innovation LABS provided the client with a seamless archival process:
- Multi-System Support: Enabled archiving of various QMS data and future ingestion of DMS and LMS content
- Scalable Architecture: Handled large data volumes without performance compromise
- Audit-Ready Access: Delivered intuitive search and retrieval capabilities for inspectors and internal QA teams
Validation team insights
What made the project smooth and successful:
- Established trust from a recent cloud QMS platform implementation and strong alignment with the client team on data verification expectations and test scripts enabled a seamless transition into the initial testing cycle.
- Efficient, well-coordinated validation effort due to early alignment to client expectations.
Project challenges (data verification):
- Source-to-Target Comparison: Verification was more complex than anticipated due to limited familiarity with the client’s legacy QMS system. Some fields were not visible to testers using read-only profiles.
- Unexpected Issues: Duplication of the letter ‘f’ in certain fields was identified during formal testing.
- Proactive Alignment: The importance of aligning early in the project on the client’s expectations to ensure downstream validation activities proceed smoothly and efficiently.
Key benefits delivered:
- Risk Mitigation: Eliminated dependency on legacy system licenses, avoiding costly compliance risks.
- Operational Efficiency: Simplified data access across systems, reducing time spent on audits and system maintenance.
- Future Proof Solution: Positioned the organization to expand archiveIQ® usage beyond QMS to other regulated DMS and LMS content repositories.
Why it matters
For large-scale pharmaceutical organizations, retiring legacy systems isn’t just an IT project, it’s a compliance imperative. ArchiveIQ® bridges the gap between operational needs and regulatory responsibilities, ensuring data integrity, security, and accessibility long after system sunset.
Looking to optimize legacy system strategies and data management initiatives? Reach out to our RQC experts to learn more.
This publication contains general information only and Sikich is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or any other professional advice or services. This publication is not a substitute for such professional advice or services, nor should you use it as a basis for any decision, action or omission that may affect you or your business. Before making any decision, taking any action or omitting an action that may affect you or your business, you should consult a qualified professional advisor. In addition, this publication may contain certain content generated by an artificial intelligence (AI) language model. You acknowledge that Sikich shall not be responsible for any loss sustained by you or any person who relies on this publication.
