Cloud-Based Software: Changing the Dynamics of the Life Sciences Industry

Cloud-Based Software: Changing the Dynamics of the Life Sciences Industry

Your Company’s drive to make each person more productive than ever before has led to increasing convergence of the physical, digital, and biological processes and technology you perform into integrated software and automated systems.  The past decade has seen the development of software supporting virtually all of the Life Sciences Industry, first as downloaded software and now, increasingly, as cloud-based software that is accessible to your entire organization from anywhere on multiple platforms.  Innovative companies invest in software systems that support their continuous improvement in compliance and productivity.

How does a software system benefit the organizations?

  • Provides a compliant, secure, flexible, and robust foundation for operations.
  • Let’s you do more with less staff.
  • Enforces your processes.
  • Minimizes delays.
  • Automates Tasks, Record Keeping, and Analytics
  • Enables better decision making with input from data capture and analysis.
  • The system does it your way, so you don’t change the way you work.

PSC SoftwareTM has the cloud-based software products that provide the full featured electronic Quality Management System with unparalleled flexibility to automate your entire business; the world-best, easy to learn, and easy to use real-time inspection management software; and the ready to use, plug-and-play electronic Quality Management System that comes complete with all the documents for your industry segment.

PSC Software Solutions:

  • Adaptive Compliance Engine® (ACE™) is the full featured electronic Quality Management System that allows you to automate virtually any process.  ACETM integrates a wide range of tasks into a comprehensive and seamless platform, including ACE Auditor™, ACE Analytics™, ACE Inspection™, ACE Docs™ for controlled document management, ACE LMS™ a fully integrated Learning Management System, and ACE PLM™ for Product Lifecycle Management.  ACETM is the scalable and highly-configurable enterprise quality management system that easily adapts to any business process to enable tracking, management, and reporting of all compliance, quality, and operational activities in real-time.
  • AuditUtopia® is the world’s-best, stand-alone, real-time inspection management system.  AuditUtopia® is the software tool that allows your inspection team to streamline request handling and improve response time.  AuditUtopia® is so easy to use that your entire team can learn to use AuditUtopia® in less than a day.  AuditUtopia® is designed to keep your audit team organized, ensure a free flow of information, and address and track priorities.  Whether you have any Quality Management System, when it comes to inspection management AuditUtopia® gives you all of this capability and more for an incredible price:
      • Configurable Reports
      • Log Inspection Notes
      • Real-Time Updates
      • Chatrooms and Private Chats
      • In-System and Email Notifications
      • Track and Manage Requests
  • ACE Essentials™: ACE Essentials™ is the complete, fully validated, Turnkey Electronic Quality Management System (EQMS) software created for highly regulated industries. ACE EssentialsTM comes with all the necessary standard operating procedures and policies to deliver you fully compliant quality management system at an unbeatable price. ACE EssentialsTM includes document management; training management; deviation;  investigation; corrective and preventive action; design control; risk management capabilities; and much more, ready to use and fully compliant.

Cloud-based Life Science Software lets your organization ensure compliance and data integrity, respond faster, reduce time to market, address regulatory issues efficiently, and ensure continuity.

If you need more than just software, PSC Biotech™ can provide your company a full range of professional services, including computer system validation, equipment and facility commissioning, qualification and validation, risk assessment, temperature mapping, staff augmentation, and more.  PSC Biotech™ provides professional services as customized engagements tailored to your needs or under Master Services Agreements that allows you to use the services you need when you need them at an agreed cost.   Our experienced consultants are ready to help your company succeed.  Whatever your requirements, PSC Biotech™ will work with you to make it happen!

How Thermo Fisher Scientific Streamlined Inspection Management With AuditUtopia®

How Thermo Fisher Scientific Streamlined Inspection Management With AuditUtopia®

Case Study Overview

In highly regulated industries, you can count on the fact that your company will be inspected a time or two by regulatory agencies and/or your clients. Most companies manage these inspections using a mixture of programs for different aspects of the inspection. A leading problem with that approach is that these programs do not communicate with each other or update automatically.

Ridding Manual Processes During Inspections

Thermo Fisher Scientific’s Viral Vector Services (VVS) division (formerly Brammer Bio) is a contract development and manufacturing organization (CDMO) with three cGMP facilities and over 100 successful client projects under their belt. With multiple facilities and clients, the VVS division was being inspected two times per month. During each of the inspections, the team was using multiple tools to manage inspections requests and to communicate between the inspection room, support room, and employee’s in the office.

Audits and inspections undoubtedly call for numerous teams working simultaneously to fulfill requests. When these teams are not in sync, opportunities for missed and incomplete request responses arise. This causes strain on the inspection process as well as on the employee’s tasks.

For these reasons, Thermo Fisher brought on AuditUtopia®. Prior to AuditUtopia, Thermo Fisher managed the communication and requests surrounding the inspection using manual tools to communicate with those outside of the inspection room.

For example, the team would use a shared Microsoft OneNote folder to keep notes and track requests. The OneNote method required the team to enter basic information such as request number and type of request and track the progress of the request manually by refreshing the OneNote file. This made communication difficult and left notes unorganized.

The Cost of a Failed Regulatory Inspection

With the cost of a failed regulatory inspection approaching hundreds of thousands of dollars, the VVS division needed a dedicated solution to manage their regulatory and client inspections. Thermo Fisher’s VVS division soon found that one software, AuditUtopia®, stood above the rest for its responsiveness, ease of use, implementation program, and single platform solution for all their inspection management needs.

Switching to AuditUtopia®

For most companies, the thought of implementing a new software to replace an established system is daunting. PSC Software™ aims to mitigate the stress and learning curve that often comes with the implementation of a new software by providing trainers who are subject matter experts on the program along with recordings of the same trainings as a reference documents for future employees.

Gaining Peace of Mind While Achieving Results

Following a seamless implementation process, the Viral Vector Service’s inspection management team is able to stay organized and on-topic of the requests and inspection as a whole. Rather than playing “telephone”, the team is relying on first-hand, written accounts of what is being said in the inspection room.

The Thermo Fisher VVS team can now track the status of each request in real time and view metrics on where they struggle to answer requests in a timely, efficient manner.  With the implementation successful, Thermo Fisher and PSC Software™ look forward to a successful long term partnership.

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