Armanino Introduces Product: Life Sciences Industries for Microsoft Dynamics AX

SAN RAMON, CA (April 5, 2016) – Armanino^LLP, 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 Sciences solution 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 only approved 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.”

April 05, 2016

About Armanino^LLP

Armanino LLP (www.armaninollp.com) is one of the 25 largest independent accounting and business consulting firms in the nation. Armanino provides an integrated set of audit, tax, business management, consulting and technology solutions to companies in the U.S. and globally. The firm helps clients adapt and change in every stage of business, from startup through rapid growth to the sale of a company. Armanino emphasizes smart technology, leading a cloud revolution of financial, operational, sales and compliance tools that are transforming the way companies do business. The firm extends its global services to more than 100 countries through its membership in Moore Global, one of the world's major accounting and consulting membership organizations. In addition to its core consulting and accounting practices, Armanino operates its division, AMF Media Group (www.amfmediagroup.com), a media and communications services agency. Its affiliate, Intersect Capital (www.intersectcapitalllc.com) is an independent financial planning, wealth and lifestyle management firm.