The 6 Essential Components of a Quality Management System

The 6 Essential Components of a Quality Management System

Quality management system is defined as “a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization’s purpose and strategic direction.” This definition is accurate, but if you’re business falls within a highly regulated industry, a quality management system (QMS) stands for much more than that.

Customer requirements and satisfaction is the overall goal in a highly regulated industry such as life science, but the regulatory bodies are the hardest to please (and for a good reason). Organizations use QMS frameworks to guide continuous improvement efforts and adopt data for evidence-based decision making. Organizations in highly regulated industries seek certification with globally recognized standards such as ISO 9001 to improve quality through transparency, documentation, and systemic approaches to improvement. The adoption of Quality Management Software typically supports modern QMS.

Switching to a robust electronic QMS can support compliance, profitability, and the development of a quality-driven culture. While there are various guidelines for a robust electronic QMS, the best-known systems for total quality management all represent the list below.

  1. Document management organizes all documents into a centralized database with approval workflows and audit trails. Electronic QMS documentation allows for easy and fast communication of documentation transfers, process monitoring, a source of evidence for conformity. Electronic documents eliminate document redundancy, reduce the risk of manufacturing products with out-of-date SOPs, and create efficiency in organizations.

  1. Reporting management allows you to share print-ready and interactive reports and dashboards with countless users. Whether you are a manager wanting to view more details in a report or an analyst who needs to visualize data. It is important that users can get what they need without delay so they can utilize that information to accomplish various goals.

  1. Inspection management allows companies to streamline regulatory inspections by tracking all requests and logging notes in a single platform. Real-time updates and in-system notifications ensures that your team is responding to requests in an efficient manner at the time of an inspection.

  1. Audit management provides the flexibility to schedule, plan, and execute various types of audits all within a single, comprehensive platform so you can manage your entire audit lifecycle. This feature reduces risk by enforcing consistent and harmonized processes of vendors while securely managing all information in a centralized system. In addition, it facilitates compliance with global government regulations and industry standards. This provides management the data needed to evaluate audit system effectiveness and make changes where necessary.  

  1. Learning management provides your company’s employees with the documents needed to be able to train on processes, take quizzes, upload files, and sign off on these educational courses all in one place. Keep up to date on training and have trainers review answers for completed assignments to educate your employees as well as avoid any non-conformities.

  1. Product lifecycle management allows users to create a bill of materials and build products through a user-friendly platform. Track all updates to products and components by seamlessly applying the change to all products, or simply swap out for just one product, all through cloud software.

If you’d like to learn more, click here for a free demo: https://www.pscsoftware.com/contact-us

PSC Software™ Launches New Website Highlighting Their Software For Highly Regulated Industries

Pomona, Calif. August 6, 2019 –PSC Software™ launched a new website to showcase their software products, which are geared toward the life science industry and other highly regulated industries. The new site offers information regarding the company’s two highly-configurable products: Adaptive Compliance Engine®, quality management system, and AuditUtopia®, audit and inspection management software.

“We’re excited to accurately showcase all that our software can do and who it can be useful for, which is really any company in a highly regulated industry,” says PSC Software™’s Chief Technology Officer, Gilbert Gomez.

Beyond the typical module-based eqms software, Adaptive Compliance Engine® (ACE™) is truly an all-in-one product which can be configured to meet any workflow and communicate with preexisting software through the API feature. AuditUtopia®, the other of the two products, is a user-friendly audit management system endorsed by some of the top-tiered life science companies and regulatory bodies in the world.

To learn more or for a complimentary personalized demonstration, visit www.pscsoftware.com.

About PSC Software™

PSC Software™, a division of PSC Biotech Corporation, provides inspection management and enterprise quality management software solutions enabling businesses to safely and efficiently deliver their products to market. Applications developed by PSC Software™ address the needs of organizations that must maintain compliance in regulated industries. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our customers worldwide.

To learn more, visit pscsoftware.com.

Media Contact:

Olivia Lepore

PSC Biotech Corporation

olepore@biotech.com

+1 (617) 803-9193

PSC Software™: The Beginnings

PSC Software™: The Beginnings

If you’re reading this, you’re either familiar with PSC Biotech Corporation being a software company, or this piece of the business is completely new to you. Either way, you’re interested in hearing about how our revolutionary software came to fruition, so here’s some background.

PSC Biotech Corporation was founded in 1996 by life science experts as a professional services company in Southern California. Through 17 years of pharmaceutical experience, John Clapham, CEO, was able to amass an intimate understanding of the processes within the life science industry that could be improved. Roughly 10 years after the inception of the professional services business, he began to formulate a vision of providing software solutions for the severely underserved processes surrounding inspections, CAPAs, and audits.

In 2007, John did just that, and thus, PSC Software™ was born. Gilbert Gomez, Chief Technology Officer, and his team diligently constructed and successfully developed the applications AuditUtopia®, EZ-CAPA and Auditca with new Web 2.0 technologies to address these needs.

Armed with the intimate knowledge of the pain points of the industry, AuditUtopia® became a high-demand product for inspection management and tracking and managing inspection requests. It soon became the flagship application for PSC Software™. With the need to scale, AuditUtopia® converted to a multi-tenant Amazon cloud infrastructure as a service (IaaS) in order to continue providing a world-class software as a service (SaaS) solution for our customers. This change enabled AuditUtopia® to become even more reliable and secure for our clients’ in-house installations.

Building on the success and experience from AuditUtopia®, PSC Software™ worked to develop a solution that could service any quality process, queue the birth of Adaptive Compliance Engine® (ACE™).
Many of the processes that govern life science companies rules in inspection, audit and CAPA processes, and the team decided these could be configured in a consolidated quality management system (QMS). Every aspect of ACE™ was built with the cloud in mind and architected to take advantage of Web 2.0 technologies. This highly scalable and highly available cloud infrastructure has enabled a seamless cloud experience for our customers. It turns out that this software would not only be able to service the life science sector, but any quality process.

Applications developed by PSC Software™ address the needs of organizations that must maintain compliance in regulated industries. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our clients.

Experience our software yourself through a free 30-day trial today.