Oracle ERP for Pharma & Life Sciences.

How does ETHX Softcon implement Oracle ERP for pharmaceutical and life sciences companies?

ETHX Softcon implements Oracle ERP for pharmaceutical and life sciences companies using a GxP-aligned implementation and validation approach. Validation work covers user requirement specifications, IQ, OQ and PQ with documented evidence and sign-off, a validation plan, and change control across Oracle releases. The Oracle configuration supports serialisation workflows for DSCSA and EU FMD, including parent-child packaging and traceability; electronic batch records with deviations, exceptions and sign-off; and electronic signatures, audit trail and access control aligned with 21 CFR Part 11.

Quality coverage includes sampling, certificates of analysis, stability testing and hold/release workflows, with Quality, Manufacturing and SCM integrated. Regulatory reporting and audit trail support are included, and consolidation across legal entities is supported with FCCS and Fusion Consolidations across multiple GAAPs and currencies. Delivery follows five steps: assess GxP scope and regulatory exposure, design the URS and training plan, build and integrate QC and serialisation, validate, and run with hypercare, periodic review and audit support.

What should pharmaceutical and life sciences companies plan for in an Oracle ERP programme?

Pharmaceutical and life sciences companies should plan the ERP as a regulated, validated system: electronic records and signatures must be trustworthy, the system must be validated for its intended use, and product identification data must flow to supply-chain partners. These obligations affect scope, timeline and supplier agreements, not only configuration.

In the United States, 21 CFR Part 11 requires validation of systems to ensure accuracy, reliability and consistent intended performance; secure, computer-generated, time-stamped audit trails that record the creation, modification or deletion of electronic records without obscuring earlier information; and electronic signatures linked to their records so they cannot be copied or transferred.

In the EU, GMP Annex 11 asks for risk management across the computerised system lifecycle, validation documentation covering the relevant lifecycle steps, risk-based audit trails that record the reason for GMP-relevant changes, and formal agreements with third parties who supply, host or maintain the system. For a cloud ERP this means a documented intended use, a risk assessment deciding which processes are GMP-relevant, a validation approach (many firms follow ISPE GAMP 5), and a plan for regression testing when the vendor issues scheduled updates.

Serialisation is the second consideration. The US Drug Supply Chain Security Act sets out an interoperable, electronic way to identify and trace certain prescription drugs at the package level. In the EU, Delegated Regulation (EU) 2016/161 under the Falsified Medicines Directive requires a unique identifier and an anti-tampering device on the outer packaging of relevant medicines, applying since 9 February 2019.

The ERP is usually not the serialisation system itself, but it must pass product master data, lot and expiry to packaging and serialisation systems, and handle returns, quarantine and investigation of suspect product. Third, batch release: quality status, certificates of analysis and QA or Qualified Person release should gate shipment as a system control.