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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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.

Clinical Trials Cost Management in Accounting Software

When it comes to clinical trials costs management in a financial or accounting system, we see many different approaches depending on the type of trials, existing business processes, and the financial executives’ ideals. The approach usually fallls into one of the following three different methods.

At the simplest of approaches, we see that life science companies put a segment into their chart of accounts the represents a clinical trial, and many times a sub-trial or task related to that trial. This approach can be very simple and effective as they can then sort and report on that particular segment on their chat of accounts, as well as allocate the appropriate expense or revenue activity to that segment. However, there are a couple of challenges associated with this approach, including those trials that might span multiple fiscal years; because of the desire to track a budget specifically to that trial (or sub-trial, task and other dimension). A typical GL budget can only be associated to one fiscal year. Also, if there are a lot of trials coming and going, you increase your chart of accounts exponentially.

A second approach we see it that a company uses a “project accounting” type system to track costs against a “project.” this is a very effective approach if a company wants employees to enter time and allocate that time to different clinical trials (and sub-trials, tasks, etc). This method can also be effective if they want to allocate material to inventory to a clinical trial. However, there is a lot of system management, software costs and implementation costs that go with maintaining such project accounting systems.

Lastly, we see the life science companies using another means to track their activity associated with clinical trials, and that’s by creating a separate “cost bucket”or “dimension” that can sit outside the GL account code structure. These dimensions can have sub-dimensions or tasks associated to it, along with its own budget and filtered reporting on the trial. This budget can then span multiple fiscal years, unlike a GL budget. With this “cost bucket” also off the GL account code it is easy for them to come and go without affecting your overall size of the chart of accounts. This last method is becoming the most popular method for clinical trials costs management amongst our life science clients.

Written by Andy Collins, Partner at Tridea Partners. Tridea Partners is a Microsoft Dynamics Partner located in Southern California specializing in Life Sciences.