ERP Gap Assessment
CGxP ERP Risk Exposure Gap Assessment, Mitigation, and Solution Support
The Kymanox Intelligent Enterprise Team is an international provider of ERP compliance (e.g., FDA, EMA) solutions for life sciences. As pragmatic client advocates, we offer a patient-centric, risk-based approach balanced with both regulatory requirements and business needs.
Kymanox is the perfect partner to provide CGxP ERP Risk Exposure Gap Assessment, Mitigation, and Solution Support for ERP System and Computer System Validation (CSV) and Regulatory Compliance. Kymanox can provide technical and quality support for an assessment of the enterprise computer system. The assessment evaluates for risk exposure in the ERP system, the affected processes, and proposes a tailored solution for mitigation that is regulatory agency-compliant and incorporates accepted practices for CSV support.
At Kymanox we take a process-oriented approach to ERP validation that is fully integrated with a risk assessment where CGMP standards are required. Our method ensures that the target ERP landscape is validated and implemented while reducing or eliminating risks concerning product quality, patient safety, and data security. Most importantly, this guarantees that the GAMP 5 goal of a risk-based approach for compliant CGMP computerized systems is fulfilled and the entire implementation is aligned along process-driven business objectives, enabled by the new ERP technology. Validation activities are often viewed as separate to the overall ERP transformation initiative; however, the Kymanox view is contrary to this belief and we support that validation activities be well-integrated into the standard phases of the enterprise roll out.
Overview and Highlights for a 5-Week Risk Exposure Gap Assessment:
- Collaborate to review existing operations, ERP software systems, key personnel, and governing quality systems. Review will include process maps (or equivalent), identifying ERP touch points, CGxP data touch points, control of CGxP data, interfaces to software systems, interfaces to devices, and data migration.
- Collaborate in person over a 3-day period to examine software and personnel, business process, and CGxP touch points, quality systems, and documentation.
- Perform gap identification with a view toward conveying both the gaps and risks between the current state and proposed future state ERP environment. This phase evaluates risks relative to the Client’s ERP package as it relates to CGxP functions.
- Qualify the specific risks identified during the ERP gap assessment exercise.
- Draft and finalize a detailed gap assessment report that identifies the compliance gaps, risks, and definitive mitigations.
- Draft and finalize a solution set to mitigate uncovered gap assessment risks.
Base price: $28,080.00
Please contact our team directly at firstname.lastname@example.org to discuss custom options to meet your company’s specific needs in regards to CGxP ERP Risk Exposure Gap Assessment, Mitigation, and Solution Support.