Medical device manufacturers function in one of the world’s most extremely regulated industries, which makes the need for a particular manufacturing ERP system much more essential. When success can hinge on time-to-market, traceability, high-quality management, and compliance with the newest regulatory necessities, a medical system ERP can add a great deal of value. Whether an organization is a enterprise capital medical system start-up, or a growth-oriented medical machine company, every should follow closely managed processes to develop and manufacture merchandise in order that they meet the strictest high quality requirements. Let’s discover the business obligations and the highest components you must think about in a medical system ERP.

How a Medical Device ERP Simplifies Compliance

To absolutely manage quality and track all data associated to merchandise throughout the whole supply chain, the ERP needs of medical system manufacturers have to be met with methods that monitor manufacturing, purchasing, documentation, and traceability of products, and achieve this while cost-effectively managing compliance necessities.

The U.S. Food and Drug Administration (FDA) 21 CFR 820 QMS necessities are in place to make sure product security and efficacy of medical devices. Good manufacturing practices require medical device manufacturers to use related sections of FDA Part 820 to their operations. This makes an appropriate ERP an important piece of a general quality management system for medical units — one which have to be validated for regulatory agencies.

Medical device ERP solutions should assist companies meet all FDA requirements for each software program and operations. Manufacturers ought to look for complete compliance monitoring, high quality administration (QM) and provide chain administration functionalities.

Identifying medical device companies’ top ERP requirements

To ensure your supposed Medical device ERP checks all of the boxes, you first must identify what these boxes are. Here are the highest 10 things to look for when evaluating a brand new ERP system for your group, similar to QAD for life sciences. It should:

  1. Ensure quality requirements compliance similar to TS13485 and ISO 9001
  2. Meet FDA software validation necessities
  3. Secure digital signature and document management to adjust to 21 CFR Part 11
  4. Provide full visibility, management and audit path of manufacturing processes
  5. Offer Integrated Corrective Action/Preventive Action (CAPA) performance
  6. Deliver lot and serial monitoring and traceability
  7. Include guarantee and repair tracking
  8. Ensure regulatory compliance
  9. Include supplier management/approved vendors settings
  10. Eliminate time-consuming, paper-based monitoring systems

ERP Consultant Help for Choosing Your Medical Device Manufacturing ERP

Strategic Information Group helps medical machine firms leverage QAD ERP for life sciences and likewise affords a full range of medical device solutions including ERP, CRM, and QMS. We assist enterprise capital medical machine startups to commercialize and established firms attain their exit methods, akin to IPO or company sale.

The Strategic team serves medical device manufacturers within the San Francisco Bay Area, Southern California, Boston, and different areas across North America. We assist every consumer to meet the important wants of Life Sciences manufacturers:

  • Fully built-in enterprise processes, together with: Manufacturing, Financials, Quality, CAPA, CRM
  • Validation of FDA software in compliance with GMP, SOX, and FDA regulations
  • Device and Batch History Reports and help for FDA audits/recalls
  • Cradle-to-grave traceability, serial family tree and controls for FDA CFR 11 and ISO3845
  • Flexible and affordable deployment choices together with Cloud ERP and mobile access via iPad, iPhone, Android

Get our free ERP RFP template, designed particularly for the needs of Life Sciences corporations by contacting a Strategic representative.

Author's Bio: 

Business solution-centric Odoo Consultant and IT professional with about 11+ years of experience spanning Odoo delivery, Sales, pre-sales, Odoo product development, Odoo business consulting, outsourcing & ADM services in leadership positions.

• Has headed Practices for Enterprise Solutions ( SAP, Baan & Odoo )

• Experience across domains likeSales and Marketing, Logistics, Manufacturing, Retail, Chemical, Automotive maped to Odoo

• Extensive experience in large program delivery & business process transformation consulting (Odoo Consultant) for multiple programs

• Demonstrated experience in designing new product & service offerings and executing global Go-To-Market strategies for new offerings for new market penetration

• Proven leadership skills with balanced focus on people, processes & technology

• Pioneered the use of ERP systems in various Processing Industry

• Worked as Process Heads of Marketing, Sales, Purchase, HR, ERP Project deliveries and also worked as Business Heads for many companies like IBM, JKT, Denave India, FCS and presently at Apagen