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:

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5 Steps to a Smooth Dynamics GP Upgrade

New versions of Dynamics GP are released every couple of years. As new versions are released, older versions eventually fall off the supported list at Microsoft. When this happens, it is a good time to consider an upgrade to the current version of Dynamics GP. Don’t worry; your unsupported version will not automatically stop working. However, you do run the risk of having compatibility issues with GP and the other applications that support or interact with GP. Another reason to upgrade is to take advantage of the features introduced in the new version of GP. A list of new features can be obtained on the www.Microsoft.com\dynamics site.

Many accounting and finance users have the “if it aint broke don’t fix it” feeling about upgrades. This sentiment is rooted in the concern that the upgrade will cause some issues that don’t exist today, so why risk it. As a formal accountant, I completely understand the concerns.

After 18+ years supporting GP, and performing over 80 upgrades, I have put together a list of the 5 things you should follow that will all but guarantee a successful upgrade. If you follow these 5 steps, your concerns should subside, and you will be able to reap the benefits of being on the most current version of Dynamics GP.

1)      Know Your GP Environment:

  1. Which GP Modules are installed and in use – Some modules will require special steps during the upgrade.
  2. Are you using any 3rd party (ISV) products – these will need to be installed and upgraded separately.
  3. Do you have any customizations or integrations with GP – these will need special attention and possible modification as part of the upgrade process.
  4. Do you have modified or custom reports – these may also need to be modified as part of the upgrade.

2)      Make sure your IT infrastructure supports the new version of Dynamics GP – You can acquire a list of System Requirements that provide a detail list of what is compatible with the new version of Dynamics GP.

3)      Perform a test upgrade – Completing a Test upgrade is recommended by Microsoft, and is an especially good idea if you have customizations, integrations, 3rd party products, or custom reports. Performing a test upgrade will allow you to identify and address any unforeseen issues that may come up. This will eliminate the downtime that the issues would have otherwise caused.

4)      Include users in the testing process – Whether you are testing the validity of the test upgrade or the live upgrade, the actual GP users need to be included in the testing. It is easy for consultants and managers to compare reports before and after an upgrade (which by the way is a must), but the users will be able to complete the real stress testing of simulated daily use of GP.

5)      Schedule the live upgrade when you have ample time to complete it – Example, if you estimate it will take 16 hours to complete the upgrade, plan to be down for 20, and give yourself ample time to complete some final validity testing.

Good luck!!

This post was written by Andy Warner, Solutions Consultant at Tridea Partners, Southern California Microsoft Dynamics GP Partner. For more information on Microsoft Dynamics GP, visit our website at http://www.trideapartners.com/.

Faster eTrigue Marketing Automation for Dynamics CRM

In June of 2013, eTrigue announced in a press release that the latest version of its eTrigue Demand Center to Dynamics CRM integration takes advantage of the Bulk Data Load API that was made available in the prior quarter release of the Microsoft Dynamics CRM C# SDK for Visual Studio. The very technical phrasing of the announcement may have allowed its significance to slip by many managers who only want to know, “What value does this provide for me?”

The short answer is that it results in faster synchronization speeds for updates that contain multiple records. The bigger the batch, the more benefit experienced. Marketing Automation Systems and Sales Workflow Automation Systems often deal with large batches of data such as imported marketing lists and bulk e-mails consisting of thousands of records. These records are both loaded into the system in large batches, and updated in large batches.

The eTrigue Demand Center integration with Dynamics CRM is designed to synchronize leads, opportunities, campaigns, and campaign members (Marketing Lists in CRM) between the two systems. Prior to the update, when a large list was loaded into eTrigue, each record was loaded into Dynamics CRM as an individual transaction. Using the new Bulk Data Load API, the integration is able to bundle a large set of records into one message, and post it to CRM in a single transaction. This dramatically reduces the time required to synchronize eTrigue and Dynamics CRM.

Faster eTrigue Marketing Automation for Dynamics CRM
eTrigue Integration to Dynamics CRM

This post was written by George Sagen, Senior Application Consultant at Tridea Partners.

Tridea Partners is a Gold Certified Microsoft Dynamics Partner serving the Southern California and Salt Lake City Regions.

 

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.

#34 on SDBJ’s Top 100 Fastest Growing Private Companies

Last night Andy Collins, Partner at Tridea Partners, and Emily Norausky, Marketing at Tridea, attended San Diego Business Journal’s Top 100 Fastest Growing Private Companies’ award ceremony as Finalists. The Event was great. There’s nothing like being surrounded by some of the top entrepreneurial professionals in your city. Tridea Partners came in 34th for highest percent growth in revenue from 2010-2012 with a healthy 120.80%! We are very honored to receive this recognition and have no plans to slow the growth. Great job to the Tridea team!

Also included on the Top 100 list is local brewery and Tridea client, Stone Brewing Co. It was great to run in to Steve Wagner and the gang at the event and share in the our accomplishments. Cheers to more growth!

 Top 100 Fastest Growing Private Companies'
Tridea Partners celebrating with Stone Brewing, Co.!