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MAXLife Life Sciences Quality Document
The reach of today’s Medical Device and Pharmaceutical companies is becoming increasingly global, both in the demand for, and the sale of life-enhancing products. These organizations must sustain global manufacturing and distribution processes while addressing the potential operational risks, as well as overcoming the quality, safety and revenue pressures inherent in an already complex Life Sciences industry.
Two of the biggest operational risks for Life Sciences comapnies are compliance with 21 CFR Part 11 and Part 820 regulations. Failing to adhere to these regulations can hinder shareholder confidence, erode your bottom line, and cause irreparable damage to brand equity. As a result, many regulated companies seek to implement enterprise-wide compliance and quality management solutions that can quickly address customer and regulatory issues consistent with worldwide requirements, while simultaneously being leveraged to automate and enhance business processes.
MAXLife ERP is a document management and quality control solution
for Life Sciences companies, simplifying compliance with
complete document lifecycle capabilities, including automated
workflows, audit trails, and full versioning support. MAXLife helps companies address the regulatory
requirements of FDA 21 CFR Part 820 and Part 11, as well as SOP management,
clinical document management and a range of quality functions
including CAPA, audits management, non-conformance and complaint
Benefits of the MAXLife Life Sciences Quality Portal:
Complete document lifecycle
capabilities, including automated workflows, audit trails,
and full versioning support.
Reduces time, effort, and costs
associated with manual and paper-based processes.
Enables compliance with
industry and government regulations.
Increases traceability and enforces
document / data security.
Integrated quality control and
product safety document management solution for
CAPA, SOPs, Audits, Complaints, GMPs and
MAXLife Life Sciences Quality Portal increases control over operations,
reduces the cost of compliance, and increases productivity with
one integrated solution for all quality document management needs.
MAXLife ERP can dramatically improve profitability, productivity, and product safety at even the most complex organizations.
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