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Wednesday, September 7, 2016

Need Help with Life Science ERP? Armanino’s List of Top 15 Life Science System Challenges

Posted by Armanino Dynamics Team

The life science industry is one of the most highly-regulated industries today. With complexities from testing, to labeling, to global exposures and risk, there is a lot to track and manage, and a lot to lose sleep over. Just one mistake can cascade throughout your entire product lifecycle; Armanino can help you avoid these risks.

Armanino’s Life Sciences Solution delivers the robust enterprise resource planning (ERP) capabilities of Microsoft Dynamics AX, plus extended functionality, to help medical device, biotech, pharmaceutical and nutraceutical manufacturers overcome critical regulatory, quality and business challenges.

At Armanino, we’ve identified a list of the Top 15 Life Science System Challenges in our newest life science white paper. Do any of these sound familiar to you? If so, contact us today.Life Science - Industry ERP Playbook

  1. Electronic Device History R (eDHR) and Electronic Batch Records (eBR). The FDA requires life sciences companies to maintain device or batch history records that provide cradle-to-grave traceability and document everything from raw material testing to post-sale servicing. Traditional paper documentation is not an efficient way to compile, record and update this critical product data.
  2. Limited Distribution Matrix. Life sciences firms need a way to manage the rules and exceptions around where their products can be sold. If they ship to a location where they don’t have regulatory approval/pre-approval, they may be fined, the products may be blocked, and the regulatory body may launch an investigation.
  3. UDI. The FDA’s unique device identifier (UDI) regulations require companies to gather detailed product data and print it on each product label, so the item can be tracked in case of a recall or other event. Manufacturers must also be able to prove their control over the number and destination of labels printed.
  4. Reports and Metrics. Business leaders need robust business intelligence reporting that enables them to pinpoint quality issues and trends early on, and quickly adjust their operations as needed.
  5. CAPA, NCR and Complaints. Life sciences firms must be able to identify and respond swiftly to any current or potential product quality risks, failures or customer complaints.
  6. Quality Sampling Tables. Life sciences manufacturers use standardized quality tables to determine the recommended number of items to sample when they’re testing a product or process. They need to be able to customize the parameters and obtain the information without going offline.
  7. Calibration. The FDA requires manufacturers to ensure and document that all instruments used in their facilities are properly calibrated and maintained.
  8. Multidimensional Inventory. Challenge Ingredient purity varies, so life sciences manufacturers need to calculate and manage the potency of the components used in each batch, to keep formulation consistent.
  9. Audit Management. To meet internal standards as well as FDA requirements, life sciences firms must perform regular audits of their design, manufacturing and quality processes.
  10. Electronic Signatures. As life sciences companies shift to electronic records, they must also adopt electronic signatures, per the 21 CFR Part 11 federal regulations for electronic data.
  11. Mixed Mode Manufacturing. Life sciences companies often use several modes of manufacturing. If their ERP system can only handle one of these, firms have to work outside the system for the remaining mode(s) or limit themselves to one type of manufacturing.
  12. Clinical Commercialization and Project Management. The clinical approval process is long and complicated, and often involves multiple locations and third-party vendors. Life sciences companies need a way to manage these complex projects before and after they are approved.
  13. Product Holds/Recalls. When life sciences firms see an anomaly in areas like production or equipment calibration, they need to put potentially impacted products on hold, so they can investigate the issue and determine what action to take. If the problem is severe, firms must be able to identify the affected items and recall them from the field as quickly as possible.
  14. Field Service/Asset Management. Medical device firms must keep their field equipment up-to-date and performing properly. They have to upgrade equipment promptly when they roll out new hardware or software, and when there is a problem with a product, they need to service it in a timely manner, to minimize customer down-time and prevent potential misuse. They must also maintain records of asset management status, for future upgrades and in case of potential service exposure issues.
  15. Revenue Management. Life sciences firms must meet industry- and business-specific requirements around revenue management in order to comply with general accepted accounting principles (GAAP). These include the deferral and recognition of revenue from distributor sell-through arrangements, and the recognition of revenue from bundled products, which may include hardware, software, services, warranties and maintenance agreements.

If any of these challenges sound familiar, it could be time to talk to the Armanino life sciences team today. Contact us.

Download the Life Sciences Manufacturer’s IT Playbook.


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