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In this 21st century, technology has influenced enterprises to embrace the power of automation and digital transformation to improve the management of time-intensive, collaborative processes.

To that end, cloud-based, next-generation QMS software has seen widespread adoption as it makes life easier for quality leaders in the following areas:

  1. Drives data-driven decision making around quality management
  2. Increases visibility of all key quality metrics, thus ensuring that both quality leaders and executive management have continuous oversight on all aspects of quality
  3. Makes it easy for diverse teams to collaborate
  4. The process of conducting Root Cause Analysis (RCA) and taking Corrective Actions & Preventive Actions (CAPA) is streamlined
  5. Document Management is automated, with easy access to all relevant documents available anytime, anywhere
  6. The process of regulatory compliance and submissions becomes easier
  7. Mobile capabilities of a next-generation QMS enables quality teams to take swift action when required
  8. Integrated risk management and training help quality teams become proactive when it comes to improving quality metrics
  9. Last but not least next-generation QMS enables ease of audit management, a crucial process for continuous improvement of quality workflows

A fast-growing biopharmaceutical company shifted from a paper-based QHSE to ComplianceQuest after evaluating a wide range of options. Headquartered in Worcester, Massachusetts, the publicly-traded company manufactures next-generation therapies for hematological cancers, glioblastoma, and rare genetic diseases. As the company started to expand its operations, the paper-based quality management system created a series of bottlenecks that affected productivity, the compliance inspection process, and traceability.

Despite a dedicated team for document changes, there were several version control issues with respect to document management, as the team used Excel and SharePoint to track things.

The company also faced several other issues due to paper-based quality management system such as:

  • Lack of real-time data for investigations
  • Time-intensive implementation processes
  • Absence of embedded training programs to upskill their people as needed

Transitioning to a next-gen EQMS

After an extensive and thorough review process, the company opted to implement specific modules from ComplianceQuest’s EQMS based on three deciding factors:

  1. Our EQMS is natively built and run on the Salesforce platform, making it highly flexible, scalable, and customizable. Scalability was a key parameter during the evaluation phase.
  2. The solution is simple to use and straightforward. In fact, the customer loved the simplicity of the entire solution, even though it was packed with features and capabilities.
  3. The solution offered the flexibility to try individual modules instead of investing in the entire solution. In the case of the biopharmaceutical company, the solutions deployed in phase one were audit, CAPA, change, nonconformance, supplier, and training.

As a cloud-based solution, ComplianceQuest EQMS offered a hassle-free implementation process in record time. The company, as a result, quickly transitioned from a paper-based quality management system and started using ComplianceQuest’s Document, Change, Training, CAPA, and Nonconformance modules to combat the primary challenges that existed.

“We chose ComplianceQuest because they met all of our criteria and it was straightforward and easy to use. If you keep things simple, you keep things compliant. They were cloud-based, intuitive, and had a great group of people on the other end.”
– Directory of QA, Mustang Bio

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Benefits of Automation

The business was able to quickly see the impact of the automation of its quality management process.

1. The modern, cloud-based quality system helped increase efficiency
As a result of paper-based QMS, the company had a long timeline for instituting CAPA, nonconformance changes as there was no effective way to drill down for detail or to see the big picture. CQ CAPA Management Software was implemented to identify and initiate a corrective and/or preventive action process and replace the time-consuming, paper-based internal procedural changes, nonconformances, and deviations. The solution helped detect trends, conduct or link to an existing investigation and root cause analysis (RCA), define action plans for change, and ensure effectiveness checks with structured verification and closure. The new system with an easy-to-use dashboard highlighted all important assignments and tasks, thus reducing manual tracking and oversight.

2. Integrated training module improved cGMP compliance
One of the company’s greatest pain points before moving to ComplianceQuest was a lack of a structured training program. CQ addressed this issue with CQ’s LearnAboutGMP Solution – an on-demand training service integrated into CQ Training Management. Designed specifically for life sciences organizations, the learning paths and certifications are easy to set up as is tracking all employees’ training to maintain critical regulatory compliance. Coupled with CQ’s Document module, the system ensured that the manufacturer followed procedures – completing training, filling out the required forms and checklists, checking results, auditing, and acting on any deviations quickly.

3. Data integrity made FDA inspections easy
Periodic FDA inspections were hindered by unwieldy and expensive document storage. The manual data entry process also increased the risk of documentation errors which could affect compliance. Driven to improve data integrity, the company leveraged CQ’s Document Management module to manage the entire document lifecycle, gain complete visibility, and rely on a single source of truth across all locations for more effective decision making. The module offered the manufacturing and clinical teams complete access to procedures without dealing with a bundle of binders and papers. As a result, FDA inspections became less tedious as all the information is now available at the fingertips.

ComplianceQuest EQMS also created a positive user experience with the entire top management of the customer. Specifically, it helped with:

  • Greater traceability and searchability
  • Automation and ease of regulatory filings and auditing processes
  • Increased accountability among team members
  • Freed up resources, staff for other initiatives
  • Streamlined workflows and SOPs that are easy to adhere to

Future-Proof Your Business with ComplianceQuest EQMS

A next-generation EQMS shifts companies from reacting to quality events to predictive and proactive quality management, turning data into intelligence and actionable insights.

ComplianceQuest EQMS accelerates product innovation, speed to market, and operational excellence, helps meet regulatory requirements and improves customer satisfaction through a smart, adaptable, flexible, and connected quality management system – a catalyst for continuous improvement.

ComplianceQuest is one of the fastest-growing, 100% modern cloud-based Enterprise Quality Management systems in the market that is natively built and run on the Salesforce platform.

For more information, or to request a demo with a ComplianceQuest expert, visit here: http://www.compliancequest.com/online-demo.

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