When evaluating ERP systems for a life sciences company, executives should ensure that in addition to typical ERP requirements for managing operations and finance, any ERP solution under consideration should include capabilities that address industry-specific requirements. Read on to learn about those capabilities.
Serial and Lot Number Traceability
Part of 21 CFR and other similar industry regulations require that a life science company can track and trace all components and materials through the entire value chain. That means the ERP systems must be able to record serial or lot numbers for all components received from suppliers and be able to link those to finished units in use by customers. This functionality helps to improve response time while limiting the cost and scope of recalls. Not all ERP systems keep track of serial numbers, and some can track serial numbers or lot numbers but not both.
As Built / As Maintained Configurations
For government compliance, routine and preventive maintenance, warranty management, and recalls, it’s important to know exactly what product configurations exist at each customer. Configurations on customer sites may change over time as units go through periodic maintenance cycles, but manufacturers may still need to know instantly if devices should be excluded or included in recalls, CAPA initiatives or product upgrades and enhancements.
Electronic Signatures
While regulations don’t mandate the use of eSignatures, compliance without resorting to paper is more efficient. Using eSignatures reduces process times, increases accuracy and reduces costs for mandatory record keeping and proof for chain of custody audits.
Strong ECN (Engineering Change Notice) Capability
The Life Sciences industry is characterized by rapid product changes that may need to be phased in during production – while still remaining compliant with audit trails and maintaining traceability. Strong, flexible ECN capabilities will help to identify units that do and do not require changes.
BOM Effectivity Dates
The use of BOM (bill of material) effectivity dates for components is an important part of managing ECNs, tracking changes, and incorporating new components.
Inventory by Revision / Lot
Inventory stored in stockrooms and warehouses should be identified by its serial and/or lot number. This helps with ensuring the oldest items are used first to prevent expirations and obsolescence, plus it’s an essential part of inventory accounting, recall management, and the track and trace process.
QMS with CAPA
Quality management is an essential part of the business processes for Life Sciences companies. While many ERP systems purport to include QC capabilities, it’s often little more than the ability to accept or reject a quantity during shop floor operations. For Life Sciences companies, it’s essential to identify specific quality issues by item, serial number and lot and to take corrective action on any identified quality problems. A Quality Management System is too important to ignore or “bolt on” to ERP. It should be an essential, integrated part of the system.
Document Management
Government regulations require that company management ensures that employees have the proper training to perform their assigned duties, and that process documentation is always up to date. A document management system that is integrated to the ERP solution answers these requirements by enabling management to track employee training and through revision control of key documents such as work instructions.
Qualified Environment
Government regulations require that Life Sciences companies demonstrate that they have taken the proper steps to secure their data centers and that they have controls in place to prevent omission of required steps or tampering with data. Because of these requirements, some Life Sciences companies shy away from cloud deployment, but working with an ERP supplier who can provide assurance of a qualified environment in the cloud and can simplify compliance and reduce the time and expense for certifications and audits.
Validated Environment
Software validation is mandated by the FDA and other global regulatory agencies. For many years, software validation has proved to be a time-consuming task yet essential to ensure software quality. Validation is simply defined as a documented process that confirms that a system was developed and implemented in a controlled manner and performs according to its intended use. The principle of software validation is simplistic but the application of these principles in real life can be daunting.
Essentially, these ERP differences boil down to compliance requirements, but Life Science companies also need the same flexible functionality, speed, scalability and insight that companies in every industry need.
Life Sciences ERP solutions should be able to scale rapidly as companies in this industry often experience meteoric growth once their products achieve approval. At all phases of the company life cycle, the right ERP solution helps companies to reduce the cost of compliance by eliminating the need for manual systems while simplifying business processes and reducing operating costs. In addition, ERP should enable fast introduction of new products and provide insight into every aspect of the operation to support rapid, fact based decisions.
To learn more about ERP in Life Sciences companies, download our free “ERP in Life Sciences” white paper.
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