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MAXLife365 Digital Platform:Helping Life Sciences Transform Lives
MAXLife365 extends the core functionality of the Microsoft Dynamics 365 Operations application and has been a leading ERP solution for FDA regulated companies since its launch in 2009.
MAXLife365 is different than other Life Sciences ERP systems because it is:
A true enterprise solution without the price tags of Oracle and SAP.
More robust and integrated than smaller scale or niche ERP systems.
Extensible and scalable – accommodating the complexities of commercialization, high growth, M&As, or global expansion.
Built to help regulated organizations consistently meet the highest standards for quality.
Validation ready and able to be rapidly deployed with less risk and a higher ROI.
MAXLife365 enables companies to transform without the high costs and complexities of traditional ERP and process improvement projects.
“Merit has met or exceeded every
requirement levied by industry regulators
and our own internal Quality and
Regulatory staff...We were very impressed
with the quality of the advice Merit
consultants gave us starting from day one
of the engagement, and even more
impressed with the results after we
followed their guidance.”
Erik Nelson, VP of ITVolcano Corporation
Please reach us at [email protected] or +1 (630) 614-7133 to learn how MAXLife365 can help your organizationenhance and streamline compliance, improve quality processes, increase visibility and collaboration,
reduce risk and lower costs, and transform your business.
“When evaluating System Integrators in the Life Sciences space, we found that only Merit had the depth of Life Science industry experience we expected, references that were rock solid, and a string of account “saves” that were undeniable. It made for an easy choice – Merit Solutions.” Jeff Kelethut, Head of Business Systems & IT Compliance, KYTHERA Biopharmaceuticals
MAXLIFE365 FEATURES FOR FDA REGULATED ORGANIZATIONS
1749 S Naperville Rd.Suite 200Wheaton, IL 60189+1 (630) [email protected]
120 E 23rd St. 5th Floor New York, New York 10010+1 (617) [email protected]
21515 Hawthorne BlvdSuite 200Torrance, CA 90503+1 (312) [email protected]
VIG PlazaTrešnjinog Cveta
1 11070 Novi Beograd, Serbia+1 (630) 614-7133
ABOUT MERIT SOLUTUONSMerit Solutions has been working with Life Sciences companies for more than a decade, helping them manage risk, ensure operating performance, maintain compliance, and pursue global growth opportunities. Through our industry-tested combination of front end process consultants, back end technology practitioners, and industry Subject Matter Experts, we have the expertise to enable your successful Life Sciences business transformation.
MORE THAN 500 COMPANIES LOCATED ACROSS 40+ COUNTRIES HAVE RELIED ONMERIT SOLUTIONS - INCLUDING THE FOLLOWING LIFE SCIENCES COMPANIES:
Enhanced Quality OrdersAdvanced workflow and tracking ensures Product Testing Protocols are followed with full audit trails
and Electronic Signatures.
Approved VendorsApply preventative controls on changes to fields or workflows with an unlimited number of authorized users or groups.
Print to SharePointPrint forms, reports, and compliance data from D365 directly into Controlled Document
Shelf Life and Retest ManagementTrack material expiration dates in order to effectively monitor, preserve and protect the quality of products. Proactively manage retest and quarantine.
Electronic Batch RecordsElectronically manage production batch details including the date, time, raw materials, and employees involved with a batch.
Change Control for Product DataReduce risk by enforcing consistent and harmonized change control procedures for key
D365 Product data elements.
Document Management SystemAutomate and manage document control processes to ensure compliance with FDA, ISO, and other requirements.
Training and Certification TrackingTrain and track employee skills and certifications in order to ensure products are consistently and safely manufactured.
Enhanced Electronic SignaturesExtensions to D365 Electronic Signature functionsfor improved usability and to meet 21 CFR Part 11 requirements.
Take advantage of pre-configurations andbest practice business processes to reduceproject costs, risks, and time to value.
Rapid365 ImplementationMAXLife is integrated with ValidationMaster,simplifying and automating validationprocesses.
ValidationMaster IntegrationSM
Management System.
Worldwide Sampling Plans Support for ANSI Z1.4, ISO 2859-1, and NISTSeries 6.
Customer ComplaintsRobust functionality for managing complaints,including call-in-scripts, complaint rationale,investigations, escalations, CAPA, and more.
CAPA / NCRSupport for both ISO and 8D Corrective and Preventative Actions. Along with NCRs that can be automatically generated from the system.
SerializationGlobal track and trace capabilities to addresscompliance with DSCSA requirements.
Integrated AuditingDepartment and process audits are easily setupby facility and can be scheduled to automatically create planned audits with advanced notifications.
Instrument and Tool CalibrationAutomatic scheduling for preventativemaintenance and calibration of instruments by date and use requirements.