ArmaninoLLP, one of the largest Microsoft Dynamics Partners in the U.S. and a provider of integrated audit, tax, consulting services and technology services, today released Armanino’s Life Sciences Industries for Microsoft Dynamics AX, an all-inclusive ERP solution built upon the market-leading Dynamics AX platform. Out of the box, the Life Sciencessolution enhances prebuilt “best practice” templates and reduces the need for ancillary and disparate systems to support quality, compliance and regulatory needs for medical device, biotech, pharmaceutical and nutraceutical manufacturers.
“For organizations from early stage, R&D companies to established life sciences manufacturers, Armanino’s Life Sciences Industries solution delivers the assurance of an industry-specific consolidated system and the efficiency of a consolidated technology footprint,” said Jeff Russell, Armanino’s Industry Director.
A Gold Certified Microsoft Dynamics ERP (Enterprise Resource Planning) and CRM Partner, Armanino created the new Life Sciences module which delivers 95% of the functionality that most life science companies require. Armanino’s Life Sciences Industries for Microsoft Dynamics AX solution is robust and addresses top business processes in the areas of:
Regulatory Compliance: Adhere to FDA, country and government compliance requirements, including electronic batch records for pharmaceutical, biotech and nutraceutical companies or electronic device history records for medical device manufacturers. Avoid fines and penalties by capturing limitations and restricting distribution to onlyapproved locations across the globe.
CAPA, NCR & Complaint Management: Identify and respond swiftly to any current or potential product quality risks or customer complaints, including launching a non-conformance report (NCR) or a corrective and preventive action (CAPA).
Quality Management and Equipment Calibration: Easily access embedded ANSI, ISO and NIST sampling plans with quality tables to set customized pass/fail criteria and frequency, while also leveraging skip lot testing normal, reduced, and tightened thresholds. Manage calibration of any and all equipment used to manage manufacturing and quality testing.
Audit Management: Generate scheduled internal audits, record results and if needed, generate associated NCRs or CAPAs.
Aggregate Spend Reporting: Comply with the Sunshine Act and Regulatory reporting requirements for payments, gifts and travel to healthcare professionals and organizations.
Mixed Mode Manufacturing: Manage all three modes of manufacturing – process, discrete and lean – in this single solution.
Item Trace and Track: Maintain cradle-to-grave visibility and traceability to quickly and efficiently meet auditor demands for UDI-related field search information such as batch/lot or serial tracing.
Unique Device Identification (UDI): 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
21 CFR Part 11 Electronic Signatures: Generate FDA-compliant electronic signatures
Product Research & Development: Track and manage expenses, activities, milestones and regulatory requirements as projects move through the clinical trial process and undergo post-approval research and monitoring.
“Armanino is recognized for its proven track record in creating Certified for Dynamics AX solutions,” said Chuck Juhnke, Microsoft Technical Solutions Director. ”The firm has been a Microsoft Inner Circle partner for the past four years and a Gold Certified Microsoft ERP partner for more than ten years.”