Life sciences companies face scrutiny at every step of their product life cycle, and their success depends on their ability to meet these regulatory requirements. To grow their business, these firms need an ERP system that addresses their unique compliance needs, in addition to streamlining their business processes.
Although the length of their life cycles differ, life sciences companies share the same general product path:
They must meet a succession of compliance challenges throughout this journey, both before and after their products are approved.
An ERP Solution Built To Address The Top Challenges Of Life Sciences Manufacturers and delivered by SAGlobal
The Armanino Life Sciences Solution delivers the robust enterprise resource planning (ERP) capabilities of Microsoft Dynamics AX, plus extended functionality to help medical device, biotech, pharmaceutical and nutraceutical manufacturers overcome critical regulatory, quality and business challenges.
Armanino’s Life Sciences Solution compiles a current electronic device history record (eDHR) or electronic batch record (eBR) for each product, using manufacturing data collection to capture information such as the material batch/serial numbers, equipment used, work instructions and revisions, pass/fail criteria and results, quantity released, acceptance records and primary identification label.
Launch non-conformance reports (NCRs) and trigger investigations. For severe problems, based on your business risk categories, you can initiate a corrective and preventive action (CAPA). The system documents your steps throughout, simplifying regulatory compliance.
Gain visibility into your operations with industry-specific reports and BI dashboards that track critical manufacturing and vendor performance KPIs. Using this information, you can foster an environment of continuous improvement and monitoring, enabling you to quickly adjust operations when issues or opportunities arise.
Simplify and support unique device identification (UDI) requirements by eliminating the need to populate external systems with UDI data to generate compliant labels. Our solution allows you to more easily maintain UDI records by creating a single source of truth, and to support FDA labeling requirements via a built-in UDI table that facilitates transmission to the GUDID database.
Avoid fines and regulatory actions by managing the rules and exceptions regarding where your products can be sold. Capture and enforce limitations, restrict distribution to approved locations only, and add distribution confidence for sites where pre-market clinical trials have been approved.
Generate scheduled internal audits, record results and if needed, generate associated NCRs or CAPAs.
Ingredient purity varies, so you need to calculate and manage the potency of the components used in each batch in order to keep formulation consistent. Armanino’s Life Sciences Solution for Dynamics AX enables you to track and store inventory in multiple units of measure and identify the amount of active ingredient each unit contains.
Various industry standard sampling tables are available, such as ANSI, ISO and NIST, with functionality allowing you to apply sampling techniques to standard inspections, first article and skip lot plans. Flexibility is built in, enabling you to easily set customized pass/fail rates and dictate the actions to take if a failure occurs.
Use integrated calibration and preventive maintenance tables to establish the periodic activities required to keep your equipment compliant, and document the results.
Generate FDA-compliant electronic signatures (per 21 CFR Part 11) for a wide range of functions, such as signing off on an inspection or creating a new bill of materials.
Life sciences companies often use several modes of manufacturing. If your ERP system can only handle one of these, you may have to work outside the system for the others or limit yourself to one manufacturing type. Armanino’s Life Sciences Solution for Dynamics AX supports all three manufacturing modes—process, discrete and lean—in one environment and within a single product structure.
Track and manage expenses, activities, milestones and regulatory requirements as projects move through the clinical trial process and undergo post-approval research and monitoring.