Compliance with Regulatory Software

Transcription

1 Compliance with Regulatory Software Selecting a Quality Management Software System Quality Systems & Solutions Pte Ltd 20 Maxwell Road, #09-17, Maxwell House, Singapore Telephone: Fax: info@quasys.net

2 John Baby Trainer and Medical Device Expert -TUV Rheinland Lecturer - Synergy Business School MBA Quality Management Founder & Managing Director Quality Systems and Solutions Pte Ltd, Singapore Co-Founder & Managing Director Intellect Motion Pte Ltd, Singapore Founder & CEO - Digiport Holdings Pte Ltd, Singapore Advisor roles in Medical Device and IT Companies More than 12 years experience in handling worldwide medical device regulations

3 Business Case In today s dynamic and demand-driven market, the need to implement enterprise technology to keep pace with rapidly evolving operational, production, and compliance environments is key to success. In recent years, enterprise software solutions have become commonplace in many organizations, whether integrated Quality Management Systems (QMS), or Quality Management modules within larger production systems, even down to simple point solutions for Document Control or Corrective Action

4 Enterprise Quality Management Software (EQMS) EQMS is an emerging enterprise software category that manages content and business processes for quality and compliance across the value chain. It can be viewed as a quality management platform with an integrated with IT architecture and data model that facilitates cross-functional communication and collaboration

5 What to look for? Key factors EQMS s General Technology Capabilities A few of the key considerations when selecting a software vendor, some pitfalls to avoid, and technical considerations for ensuring the software system is a good fit for your business

6 EQMS s General Technology Capabilities The solutions market for EQMS varies by functionality, industry, technology delivery platforms, company sizes served, and numerous other characteristics. There are, however, a set of typical capabilities that most vendors offer and/or are heavily investing in. These include: A modern web-services based technology platform An approach for deploying functionality. Applications are built on the platform with integration between applications Pre-configured interoperability with other enterprise applications like ERP, SCM etc GUI is web-based, role-based, avoids forms, and focuses on workflow execution

7 Closed Loop Business Processes Enabled by EQMS Modern IT architecture offered by EQMS enables organizations to close the loop on quality management. EQMS s functionalities help to integrate quality management into end-to-end business processes across the value chain, from product ideation through distribution and service.

8 Internal Quality Processes (Engineering, Manufacturing, Supply Chain, Service) Real-time visibility of quality metrics in engineering, manufacturing, and customer service Formal NC/CAPA processes established across company Cross-functional teams in place to manage quality across design, manufacturing, and suppliers

9 Engineering Design Control Product Development Planning and Execution based on Design Control elements of planning, input, output, verification, validation, review and transfer. Design History File (DHF) based on product versions Device Master Record (DMR) based on product versions

10 External Quality Processes (Suppliers) Real-time visibility of quality metrics in supplier performance Supplier scorecards established to measure and monitor performance Supplier quality data collected automatically through web-based portal Statistical analysis used to monitor and analyze real-time supplier quality data Standardized escalation processes exist for supplier quality and non-compliance events Suppliers are included in design for quality initiatives

11 Compliance and Risk Compliance processes are easily understood and documented Formal audit management processes established to understand current compliance status and identify area for improvement Formal risk management framework established Ability to identify risk factors across operations, quantify, visualize, prioritize and mitigate risk factors across operations

12 Select your solution based on Software s flexibility Look and Feel Integration Scalability

13 Flexibility to Adapt to Your Business Processes The most important consideration is the ability of the system to adapt to your existing business processes, and be flexible enough to change and improve as your processes change and improve. software vendors build their systems around a generic, best-practices approach that cannot be changed without substantial time and cost

14 Flexibility Find a solution that is truly flexible and configurable, and can configure all aspects of the software, including workflows, forms, fields, reports, business rules, even the look and feel. Configuration should also be easy for non-technical administrators Careful and thoughtful attention to the software s flexibility is key to a successful implementation

15 Look and Feel Look for systems that are able to match your company s branded image, without programming. Many systems will claim their configurations can be made to the look and feel, but often fall short in allowing layout changes. Having a system match your company s look will make the system less foreign to the end user, and make them more productive and comfortable with the system.

16 Reporting Make sure the system has robust reporting and searching tools, so that you can find data and trend data with ease. Many vendors will claim they have reporting tools, but through a third party license agreement, driving up the cost of the system. Furthermore, make sure that the system can generate the reports you want. Without proper reporting the data becomes useless to you.

17 Integration Systems that can integrate across your enterprise can dramatically improve operations. Look for systems that can integrate data from production systems and push and pull data, providing true real-time communication. Many systems can fall short of advanced integration, and usually have limitations. Consider the systems you interact with and ask for a demonstration on how the vendor plans to integrate with your other systems.

18 Scalability Whether it is an immediate need or a longterm goal, factor in the ability to scale to multiple facilities, contract manufacturers, suppliers and customers. Many vendors offer highly customized workarounds to manually sync data from one site to the next, sacrificing real-time visibility and standardization in the process. Look for systems that are able to provide a central location for managing locations, sites, keywords, access rights and processes ensuring each facility is able to conduct business in their terms, but provide a real-time rollup of data to the enterprise.

19 The End User Experience Consider your end users when selecting a software system. End user productivity is key to a successful implementation, and comfortable users are happy users. Many vendors do not understand quality and compliance as you would, and develop products that are functional, but not end user friendly. Look for configurable systems that can match a look and feel of familiar systems in your organization, or even mimic legacy systems you are replacing. Simple colors and styles can make the difference.

20 Finally Look for a vendor who understands your business. For example, a vendor primarily focused in Pharmaceuticals may not know what a discrete manufacturing process will entail and vice-versa. Look for vendors who have a background in your industry and see how their product will map to your business.

21 QUASYS BlackCAT You Design Host Control Use anywhere Not a Singe Line of Code!

22 Contact QUASYS Quality Systems & Solutions Pte Ltd 20 Maxwell Road, #09-17, Maxwell House, Singapore Telephone: Fax:

23 QUASYS Quality for your success THANK YOU!

24 SINCE 2005 QUASYS Medical Device Services Corporate PROFILE

25 Who We Are Committed to deliver QUASYS means your success. We are committed to provide all that is needed to satisfy your needs, regardless of whether it is to develop an innovative product or to build a multi-national company. Niche service Support for Startup companies. We are the one stop solution provider for any start-up company by connecting them to the incubators, advisors, investors; supported by our services that is needed to make a successful start-up. Medical Device Experts Our medical device team provide answers to medical device companies struggling to develop, market and sell products that satisfies technical, regulatory and quality requirements.

26 Why Choose Us 1. QUASYS is an unique process, technology, sales and distribution partner for companies. 2. QUASYS is a service provider with answers for your needs to develop new products and solutions. 3. QUASYS is a trainer who provides you the tools to make your company successful

27 Medical Device Services Regulatory Consulting Process Consulting Clinical Trial Services Training

28 Medical Device Services The following are some of the companies and institutes for which we are able to provide our medical device services