Скачать или смотреть Orcanos ALM/QMS - The Power of Integrated Quality Management System

Orcanos ALM 7.0: The Power of Integrated Quality System Rami Azulay Mar 2014 Phone / +972.3.537.2561 Email / [email protected]

Maximize Shareholder Wealth: Maximize Shareholder Wealth Orcanos Ltd. 2

P&L: P&L Increase Revenues Reduce Cost Orcanos Ltd. 3

What is Quality and Regulatory?: What is Quality and Regulatory? A HUGE COST! Orcanos Ltd. 4

Do More for LESS and with LESS: Do More for LESS and with LESS Orcanos Ltd. 5

Who is taking the heat?: Who is taking the heat? Orcanos Ltd. 6 REGULATORY QUALITY

QPack 7.0 Medical Challenge: QPack 7.0 Medical Challenge Orcanos Ltd. 7 Design Manufacturing Manufacturing Distributor Software Design Hardware Design Regulation Distributors Regulation Distributors Parent Company

What There is out there?: What There is out there? Access Databases CAPA Complaint Handling Training Various Servers Document Control Quality Record File Cabinets/Desks Documents Quality Records Orcanos Ltd. 8 Employee Computers Design Documents Design Records Documents Quality Records Email/Flash Drives Documents / Records Distribution SharePoint Collaboration

What Must Companies Do?: What Must Companies Do? Reduce the risk and cost associated with the achieving FDA compliance in a validate system Comply with the Regulatory & FDA 21 CFR to streamline approval process and maintain trace-ability Maximize the profitability of new and existing products Collaborate early and often to reduce product costs and minimize the risk of non-compliance Accelerate new product introductions to drive market share and top-line growth Engage suppliers and partners early and often to leverage expertise and reduce "designed-in" cost Orcanos Ltd. 9

What Must Companies Overcome?: What Must Companies Overcome? Non-complaint processes for capturing and reporting product records such as DMS DHR DHF, Quality, Training and supporting regulatory audits Silos of information that lead to confusion, redundancy and process latency Lack of consistent business process across discipline to manage change Fragmented and disconnected product information across design and quality disciplines (i.e. CAPA, DHF, NCMR, etc.) Poor or no collaboration across enterprise and external resources Ever-increasing global marketplace for doing business Orcanos Ltd. 10

FDA's Changing Perspective: FDA's Changing Perspective FDA's PAST APPROACH FDA's NEW MANDATE Isolated functional units was the norm Demanding an integrated system-oriented approach to compliance Focus was on remediation of 483 and warning letters exclusively Enforcing that compliance is built into each quality system Fragmented compliance system acceptable Want companies to have integrated compliance systems Batches on hold, delayed investigations and lengthy reviews were common and accepted Wants companies to do real-time investigations Inactively to identify process improvements was ok Calling for electronic batch records, real-time batch record review and enterprise-wide visibility of compliance activity Orcanos Ltd. 11


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