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Quality Management is deeply embedded in business processes throughout regulated enterprises, and yet too often we see customers struggle with multiple systems for managing the different activities; it is not unusual to have separate systems for:

  • Customer complaints
  • Deviations
  • Audits
  • Quality Documents
  • Training management

There are immense gains in compliance, cost, efficiency, and user satisfaction, to be made by moving everything into a single system.

Compliance

“QMS is only needed for compliance.”

A strong, combined QMS and Quality Document system provides many opportunities for limiting costly mistakes. If you can drive change requests and CAPAs directly around an SOP in a single system, you can automate processes such as ensuring Change Requests have to be Approved before associated SOPs are, or that CAPA items are automatically closed after associated documents are approved and so on. Likewise, planning audits with associated pre-audit documentation requirements, potential CAPAs including documented proof, and collaborating with external partners should all be possible in one system.

The key to compliance is ensuring that you have consistency in data across your company; avoiding duplications in separate QMS and Documentation systems takes you a long way down the road to this goal.

CARA provides unparalleled automation across activities, as well as full data integrity and audit trails for demonstrating regulatory compliance.

Cost

“Implementing Quality Management Software is expensive and time consuming.”

Combining rich QMS and Quality Document Management functionality provides a highly cost-effective solution to all your Quality needs without compromise. Generis specialises in truly understanding your business and your individual requirements as Quality Management simply does not work on a ‘one size fits all’ basis. Choosing our cloud-based Quality system reduces both time and effort as servers don’t have to be maintained in house, and although it is cloud hosted, we still do not force any expensive upgrades onto our customers: any changes are completely your choice and on your schedule.

For one global Top 20 Pharmaceutical customer we harmonized their Quality Systems globally from 16 source systems (including Trackwise, MasterControl, Documentum and SharePoint) into a single CARA Quality system – removing the costs of maintaining the separate systems with their associated infrastructure, security, backups, upgrades and support staff. The initial move to CARA cost €500,000 less than the annual maintenance and upgrades of all the source systems, while the annual costs thereafter were only 20% of the original costs, providing an immediate and significant ROI.

User Satisfaction and Efficiency

“We’ll have to adapt our business to fit the QMS”

Many external clients, partners, and authorities require QMS certifications and processes, however, there are also profound internal benefits for your company. By having a user-friendly, integral QMS, people can learn, verify, and update their business processes easily. Not only does this mean that essential processes can occur correctly and efficiently the first time, but that people are more likely to raise and effectively address organisational issues than to build work-arounds. If employees feel that they can not only raise issues, but also drive changes in their daily activities, business efficiency and innovation can thrive.

While it’s obviously true that you must work with the rules of compliance, as with all our systems, our Quality solution in CARA is highly configurable, to suit the requirements of each individual business. You can tailor your interface, workflows, security, reports, and capabilities to provide an intuitive and efficient experience for every part of your business. Many people have naturally negative perceptions of Quality processes and systems; it’s too hard, too much effort, or too confusing to adopt. Creating a system that provides justthe functionality and feature-set that a group of users needs can be an essential part of changing that perception and driving a more responsible community.

If you want to talk with a Generis specialist about your Quality System, contact us at info@generiscorp.com

To find out more, join us for our Webinar: “QMS with CARA”, on 11th September, 2019 8:00 AM PDT.

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