When it comes to selecting Enterprise Resource Planning (ERP) software, highly regulated companies need to be particularly aware of the implications that their software purchase can have on process compliance. The requirements for selecting and implementing an ERP system are daunting.  Add the complexity of mandatory compliance with FDA regulations to the mix and the selection of the correct system becomes business critical. Selecting software that properly fits both your company and industry requirements can maximize productivity and profit and provide the process control required to maintain strict quality standards.

The wrong choice can have consequences that run from minor inconvenience to process instability.  For pharmaceutical manufacturers, process instability can lead to product recalls, lawsuits, and even death.  Due to the hefty nature of these consequences, drug manufacturers face high levels of scrutiny from both government regulatory bodies and the public. This scrutiny increases the pressure to meet stringent quality, traceability and document control standards, including compliance with Title 21 CFR Part 11.

Mitigating these risks is paramount, and ERP is commonly used to do this.  Unfortunately, companies often fail to realize until they are in the implementation phase that the ERP they selected needs to be heavily customized to meet even basic needs. Modifying the base code of the software to fit the unique requirements of your business often seems like a good idea during implementation. Once implemented, those customizations can have unforeseen implications. Customization means you will need to pay someone to write the code, both up front and also any time in the future there is a change to your business. It also means that your ERP system is now the only one of its kind, which can cause problems with ongoing upgrades, maintenance, and support.

Every vendor has a different approach to customization and many will claim you can implement their system without customization. It’s important to ask every vendor how often they are required to customize the software to meet their clients’ needs — how many “vanilla” implementations do they do vs. customized solutions — and how they handle requests for customizations.

Customizations can complicate the Title 21 CFR Part 11 validation process, as each change to the base code of the software will require a new validation.  Most importantly, as you move away from the original software you will need to ensure that the functionalities have not been affected in a way that negatively impacts your ability to truly manage the process. An ERP solution that offers user-configurable options is simpler to implement, easier to maintain and provides more process control while still granting the users flexibility.

To avoid customization when selecting an ERP system, look first for a solution with built-in functionality for pharma manufacturing companies, as well as all of the traditional ERP functionality. An ERP system that can offer all of the required functionality within a single non-customized solution will offer the best process control. 

The majority of ERP solutions on the market today are “integrated” software packages.  This means that they start with a piece of software, generally an accounting module, as a platform and then bolt on the remaining modules either in house or with third party solutions.  They then repackage it as one “integrated” ERP system.  The most common point of failure for ERP software is where it links to other systems core to the ERP processes.  A single solution reduces the risk of failure by removing the process workarounds that result from welded together software. Additionally, a true single system solution ensures your process doesn’t need to go through the multiple validations required by Title 21 CFR Part 11 when systems are bolted together, thereby simplifying the validation process.  Single system, single validation.

Functionality required for pharma manufacturers includes formula management, purchasing and production QC testing, stability testing, BOM implosions and explosions, electronic signatures, a warehouse management system, batch tickets and regulatory reporting.

Formula Management is one of the most complex and challenging issues faced by process manufacturers. The best-fit ERP solution should have a robust formula management solution, allowing for scalability of formulas. Changes to formulas should immediately impact inventory, production requirements and planning in the system.  Any lag in this can cause mistakes in production. When dynamically scaled, the formula can be made to match the batch size, thus meeting current demand levels, optimizing ingredient usage, and tracking all ingredient costs.  To ensure compliance, users need to be able to track revisions to formulas, understand by individual batch exactly how a product was made, monitor any changes in quality, quantity and location, and provide an audit trail throughout the revisions.

Organizations need to have complete flexibility to manage how often Purchasing and Production QC Tests are performed, what is tested — whether it is a group of items from a specific vendor, multiple lots of items or individual ingredients — and what amounts are tested. Test results should be documented for reporting, tracking and forecasting, and automatically put lots in inventory on quality hold until the test results are entered into the system. If an item fails the QC test, it should not allow the items to be used in the manufacturing process.

The ERP system should allow for Stability testing of inventory to ensure quality of inventory and product potency over time.  The system should manage specified retest periods for both raw materials and finished goods.

Pharma manufacturers must employ rigorous lot tracking capability, so these QC functionalities are critical. They greatly improve ingredient traceability throughout the supply chain and throughout a given product’s life cycle. With the right ERP solution, there are virtually no barriers to implementing additional tracking steps, thus improving visibility when problems do occur.

BOM Implosions and Explosions give companies the ability to track multiple levels of each lot of raw materials that went into a finished good.   If an item is recalled further into the production process or as a finished good, the system should be able to provide users with lot implosion and explosion to show all the raw material lots that comprise the finished good or in which finished goods a raw material lot was used. This level of visibility provides manufacturers the capability to quickly and efficiently recall items, recalling only the affected lots. Where pharmaceuticals are involved, quick and efficient recalls can mean the difference between life and death.

The Electronic Signature process has taken a front seat since CFR Part 11 was enacted.  It is now vital to provide an audit trail every step of the way. All quality control results must be electronically signed and stored. Each system user should be assigned their own login and access privileges to view reports and/or make changes.  This username and password must be entered for all transactions to record who did what and when they did it.  The ERP solution should provide forward and backward traceability, so every entry is completely traceable.

Using bar-code technology, a properly designed Warehouse Management System (WMS) provides the ability to update the ERP system at any stage of the process, greatly reducing the chance of warehouse errors while improving productivity. The WMS should allow users to instantly track changes and report on inventory status through multiple facilities. The best-fit ERP solution should have a native WMS solution, which allows users transaction processing with tight controls on lot tracking. When used correctly, WMS is one of the few tools that can both reduce operating costs and improve process control.

Batch Tickets govern the production process.  The best-fit ERP solution should provide individual batch tickets that can be modified to include sign off and QC tests for every phase of production.  Additionally, these batch tickets should be archived in the system and easily accessible in case of FDA audit.

Organizations need the ability to configure their own real-time Regulatory Reports based on item masters and formulations set up in the system. The system should have the flexibility to handle a wide range of regulatory reporting requirements and provide regulatory and shipping documents like the MSDS and COA quickly and easily at the point of shipment.

In summary, a single-system ERP solution which can fulfill the unique business requirements of your industry and provide you with all of the functionality you need from formulation to shipment, without third party bolt-ons or customizations can help simplify the validation process.  The implications of choosing the wrong system are simply too steep to settle for anything less than a perfect match.