We help biotech, pharmaceutical, and medical products companies to improve efficiency and use data and insights to work faster and smarter than ever before. That way you can remain focused on researching, developing, and distributing safe products that are improving the lives of millions around the globe.
Support for both ISO and 8D Corrective and Preventative Actions. Along with Nonconformance Reports that can be automatically generated from inspections, ISO audits, and customer complaints.
Customer complaints is a full featured solution including call-in-scripts to assist customer service. Including complaint rational with investigations and escalation to nonconforming conditions and CAPA. Seamless integration to customers and return orders.
Department and process audits are easily setup by facility and can be scheduled to automatically create planned audits with advanced notifications. Audit plans and audit steps are stored in the audit table and feature integration to nonconformance and corrective actions.
Extensions to AX Electronic Signature functions for improved usability and to meet 21 CFR Part 11 requirements.
Apply preventative controls on changes to fields or workflows with an unlimited number of authorized users or groups.
Electronically manage production batch details including the date, time, raw materials, and employees involved with a batch.
Support for ANSI Z1.4, ISO 2859-1, and NIST Series 6.
Automatic scheduling for preventative maintenance and calibration of instruments by date and use requirements.
Key indicator reporting including Variable control charting, pareto charting, parts per million analysis, and vendor performance.
Track material expiration dates in order to effectively monitor, preserve and protect the quality of products. Proactively manage retest and quarantine.
Automate and manage document control processes to ensure compliance with FDA, ISO, and other requirements.
Train and track employee skills and certifications in order to ensure products are consistently and safely manufactured.
Advanced workflow and tracking ensures Product Testing Protocols are followed with full audit trails and Electronic Signatures.
Reduce risk by enforcing consistent and harmonized change control procedures for key AX Product data elements.
Print forms, reports, and compliance data from Dynamics AX directly into Controlled Document Management System.
MAXLife extends the core functionality of the Microsoft Dynamics 365 platform and has been a leading ERP solution for FDA regulated companies since its launch in 2009. MAXLife is different than traditional Life Sciences ERP systems because it is:
Watch this short video if your team is considering implementing a new Life Sciences ERP solution.
More than 500 companies located across 40 countries have relied on Merit Solutions,
including the following Life Sciences organizations.
Many pre-clinical and late stage Life Sciences companies want to implement a cloud-based, pre-packaged business application that can be rapidly deployed using best practice configurations, process models, reports, and templates.
MAXLife Rapid365 enables organizations who are candidates for an out-of-the-box deployment to enjoy a fixed fee, time bound approach to their implementation. Benefits of MAXLife Rapid365 include:
Download our free white paper to learn how you can Use ERP to Prepare for Commercialization.
High growth and global Life Sciences companies planning a digital transformation need robust software capabilities that improve supply chain performance. They also need to streamline processes to encourage more efficient and effective operations.
MAXLife Enterprise is designed for more complex, global software deployments and begins with our Business Transformation Mapping offering. Benefits of MAXLife Enterprise include:
Watch this short video to see how Business Transformation Mapping guides our clients to successful ERP investments.
Life Sciences organizations wanting to implement industry-specific enterprise ERP systems and processes with fewer internal resources and a faster timeline should consider MAXLife to:
If your team is considering your own business process, ERP, document management, or mobile projects – please fill out the form below and let us know!