4 Ways Cloud Benefits Life Sciences Businesses

What can your Life Sciences Company Accomplish in the Cloud?

In our new guide we’ll share the 4 reasons why life sciences and the cloud belong together!

In a life science business, there is no lack of data related to product development, clinical trials, production (in-house and contract manufacturing), quality assurance, costing, the supply chain and other areas of the operation. How do you make sense of it without investing in compliance, data processing and analytical technologies?

In the cloud, life science companies can take advantage of the most powerful analytical tools available today. The cloud also supports your growth with cost controls or profit erosion. As leading life science companies are undergoing transformation into digital business and other are preparing for transformation initiatives to become compliant, more relevant and more competitive, the cloud is the single most important enabling element.

Get your copy of A Guide to Transformation in the Cloud, here

To learn more about how Tridea can help you get the most out of your Microsoft solution in the cloud, contact us at info@trideapartners.com

Leading Pharma Company Moves Forward with Tridea Partners and Dynamics AX 2012

A $200 million pharmaceutical company based in Arizona has selected Tridea Partners and Microsoft Dynamics AX 2012 to support their ERP and business management needs.

One of the leading pharmaceutical (pharma) companies in Arizona has completed a formal system selection process and is moving forward with Microsoft Dynamics AX and Tridea Partners.  This pharma company selected Tridea Partners because of their experience in the life sciences and pharma industry. Microsoft Dynamics AX 2012 effectively addresses many of the pharma requirements.  “We were able to speak their language around FDA system validation, integration to CMOs and 3PLs, process manufacturing functionality along with presenting a large list of pharma references”, Andy Collins, Partner with Tridea Partners, stated.  Ultimately, we were the most expensive system (software and services), but the executive team still presented the recommendation to the Board of Directors to move ahead with Tridea and Dynamics AX.

This life science company has a complex operational model in that they use contract manufacturers (CMO) for some production, but also do internal production.  They also currently use a 3rd Party Logistics (3PL) provider, but much of this fulfillment will be moved to the new production facility.  They wanted to be certain the new system could support all these different business processes and handle the upcoming growth with their new production facility.

Tridea is a leading Microsoft Dynamics provider serving CA, AZ, UT, CO and surrounding regions.

5 Added Challenges for Life Sciences Post Commercialization

You’ve made it past the biggest challenge that faced your Life Sciences company – FDA approval. However, now as you take on manufacturing, sales, and fulfillment that come with your commercialization, there are a new set of system challenges that need to be addressed. Are you prepared to comply with the Sunshine Act, manage more rigorous expense reporting, and properly recognize revenue? How you choose to efficiently address these challenges can impact your bottom line.

Tridea Partners and Microsoft Dynamics can help you reach further success by providing the right combination of technology solutions.

5 Added challenges for Life Sciences companies need to address post commercialization

Download (PDF, Unknown)

This post was written by Andy Collins, Partner at Tridea Partners. Tridea is a Gold Certified Microsoft Dynamics AX, GP, and CRM partner focused on providing solutions for the Life Sciences industry.

Top 10 Process Manufacturing Requirements for Life Sciences

Batch Manufacturing and Process Manufacturing are very unique processes that Life Sciences companies must address to compete effectively while adhering to FDA quality and validation requirements.   These requirements can even apply before commercialization, or if they outsource certain manufacturing processes.  This mode of manufacturing is unique in that groups, formulas or “Batches” of a product are produced at one time, with the end product taking the form of non-discreet units and something that “Cannot be put back together in their original form”.  This finished product often involves the extraction of 1 or more products at the end of production.  Furthermore, the packaging of the end product needs to be independent of the formula or ingredients so the ability to easily change ingredients doesn’t create added steps to redo the packaging process.

There are ERP systems that specifically address this unique set of functionality, including Microsoft Dynamics AX.  These systems have developed a unique suite of functionality specifically to address these batch and process manufacturing requirements, making it an extremely attractive solution for those industries.  Many times these products have to address the complex issues around multi-site manufacturing as well, where the same product might be produced at different locations.  There is also an important quality assurance requirement with these companies whether at the time of receiving raw material items or quality checks throughout the manufacturing process.

There are some software system requirements that, although not specifically related to the mode of production, tend to be present in batch and process manufacturing environments because of the nature of the industries involved (example: lot number traceability in Life Sciences).

When looking into ERP systems for the process and batch manufacturing industries, the following are some of the key areas to focus attention to and make sure that software was developed with the process industry in mind.

Top 10 Requirements for Life Science Manufacturers:

  1. Lot Number Traceability
  2. Transact Co-Products or By-Products (multiple outputs per production run)
  3. Tracking Batch Records or Batch Attributes
  4. Managing Expiration Dates and Shelf Life of Product
  5. Quality Control and Quality Assurance of Purchased and Manufactured Product
  6. Number of Decimal Places for Tracking Inventory Quantities (when very small quantities of an ingredient are used in formulas or BOM)
  7. Manage Different Versions and Updates to a Formula
  8. Tracking Multiple Units of Measure per Product
  9. Planning and Managing the Packaging of Bulk Product into Multiple Forms Based on Actual Yields
  10. Separate Packaging and Production Process to Allow for Quick Formula Changes

 

There are clear differences in the requirements of a process manufacturer from a discrete manufacturer particularly in the life science industry and it is important that the ERP system can address these unique differences.  Make sure the ERP application was development with the process industry in mind, then drill into how it can address your specific requirements.

This post was written by Andy Collins, Partner at Tridea Partners, a Microsoft Dynamics AX Partner located in Southern California.

More information on how Dynamics AX adresses this industry:

Download (PDF, 438KB)

Document Management, ERP and the Life Sciences Industry

We were recently engaged by one of our Microsoft Dynamics ERP clients in the life sciences industry to help them evaluate document management systems.  Going into the meeting, I didn’t know what to expect for the key requirements as document management can mean so many different things to so many different people.  Furthermore, depending on the function or department asking the request, it can have different meanings; we were meeting with the executives from the sales, contracts and finance teams.  Finance often looks for automated purchasing and AP document management, while sales is looking to manage different contracts and agreements, and regulatory needs to implement an electronic document submission system.  We often see that the human resources team also has their unique requirements for document management.  As the meeting unfolded, the CFO was truly interested in purchasing a platform that could not only support this team’s roles and document management requirements, but also expand to other departments and create efficiency by becoming “paperless” throughout the organization.  As the conversation ended, we saw the same common themes that surround document management requirements for the life sciences community including the following:

Compliance – Getting a document management system that has been or can easily be validated.  For life sciences companies this process is otherwise very time consuming and costly as they need to comply with FDA regulations including cGMP and 21 CFR Part 11.  This is true for their ERP system as well.

Workflow – By removing paper and manual processes, the workforce can get things done much quicker and be much more efficient as opposed to pushing paper.

Document Submission – Very unique to the industry and very important to the FDA, life sciences companies are concerned about adhering to proper electronic document submission policies and formats when submitting regulatory documents for FDA approval.  Therefore, the document management system needs to address this requirement or at least be compatible with this process.

Collaboration – Today’s organizations have many different software systems producing many different forms of information, including the ERP system.  Therefore it is increasingly important to be able to view, share and interact with this important information.

Compatibility – All companies have a host of other applications used in their everyday business processes, most notable their ERP and business applications.  The document management system needs to integrate well with these processes as it’s inevitable that many of them will begin or end at this document management system.

Our team at Tridea Partners has seen many of these projects and there are many different systems to address the needs in today’s market.  When selecting that enterprise document management system, all of the above requirements should be reviewed.

Written by Andy Collins, Partner at Tridea Partners. Tridea Partners is a Microsoft Dynamics Gold Certified Partner Seriving the Southern California and Salt Lake City regions.