After countless ERP projects, Ultra Consultants knows that selecting an ERP software solution is about much more than just functionality and price point. When looking for the right fit, keep the following considerations in mind, especially if you are on the hunt for the best medical device ERP solution:
- Total Cost of Ownership (TCO) – an ideal TCO is over 5 years
- Technology Alignment – make sure the solution follows your information technology roadmap and keeps your staffing competencies in mind
- Implementation Confidence – confidence is key for a successful delivery of your future state expectations, timeline and budget
- Software Agility – this factor combined with a strategy investment of the technology vendor will allow your product to continue to expand to accommodate your future needs
- Company Synergy – your company needs to all have the same goals in mind in order to foster a solid partnership relationship for the long term
How to Integrate FDA Standards Into Your Search
When looking deeper into software capabilities beyond core ERP functionality, key software considerations in today’s medical ERP and pharmaceutical manufacturing must include certain measures to ensure a scalable and sustainable business model tough enough to endure the rigors of an FDA inspection. These measures must also make sure the appropriate security measures and separation of duties are intact.
The FDA Code of Federal Regulations (21 CFR Part 11) helps to define compliance requirements across a wide range of FDA regulated businesses for electronic records and electronic signatures. Technology and process solutions that support FDA regulated industries and have experience with CFR certifications are key to enabling FDA compliance while taking advantage of the efficiencies of electronic document submissions and automated process management.
Ultra’s Experience with Medical Device Clients
Making significant strides in business transformation requires an experienced team to conduct thorough evaluations of both process and technology capabilities coupled with a comprehensive change management approach to drive success across all facets of the business.
Recently, Ultra was chosen to lead a medical device manufacturer through their business transformation initiative. Ultra’s deep understanding of the Medical Device industry coupled with our vast ERP experience enabled this company to achieve new levels of success. In addition to the focus areas mentioned above, Ultra guided this manufacturer in designing robust future state processes enabled by an independent selection of a full-featured ERP solution that best matched their business. These key features include:
- Robust document management, versioning, and security management
- Compliance tracking
- Corrective and preventative action (CAPA) management
- Quality management
- Equipment calibration management
- Supplier quality management and supply chain traceability
- Event/case management
- Electronic signature capability with workflow and accountability tracing
Not So Fast – BPI is Important, Too
Even before the software implementation is complete, our business process improvement services continue to prove successful in identifying areas for continuous improvement including: reducing inventory levels and increasing turns, reducing customer returns through improved quality management, reducing material costs through improved supply chain management, and applying JIT principals of eliminating non-value add activities. We have highlighted areas that will drive efficiency in the sales and field service teams along with a streamlining of other internal activities in Accounting, Engineering, and Customer Service.
If your business is a medical device manufacturer or distributor and you are finding it increasingly challenging to grow your business, reduce costs or maintain competitive edge, Ultra Consultants can help. Our business transformation and improvement services coupled with our independent ERP selection services and implementation management capabilities can jump start your business innovation journey to achieve new levels of capability and competitive advantage.