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!

Working Remotely Due to COVID-19? Let PSC Introduce You to ACE and ACE Essentials!

Working Remotely Due to COVID-19? Let PSC Introduce You to ACE and ACE Essentials!

Written By: Kelsey Quargnenti, Senior Marketing Specialist, Midwest

PSC Software understands the business challenges companies of all sizes are facing at this time. Forced remote working during the COVID-19 pandemic is significantly affecting the way all companies operate and for over ten years we have been committed to keeping up the pace!

PSC Software Solutions features two of our systems, ACE and ACE Essentials™. Both are cloud-based software that can handle speed and complexity, allowing your organization to work remotely during the new normal. With end-to-end solutions, our software allows you to flexibly and seamlessly run your businesses on your own terms, without suffering within the awkward confines of a one-size-fits-all platform.

Our consultant work is being performed remotely though our complimentary system Easy PSC Access, used for our clients, ensuring projects stay on track while using ACE to securely transfer files back and forth in a secure electronic system. 

By utilizing ACE for your company, you can scrutinize ever-growing sensitive and confidential datasets, realize faster responses and reduce time to market, address regulatory issues with ease, and ensure business continuity. Implementing a cloud-based digital business architecture will better enable your company to break free from the traditional legacy IT system and all the outdated constraints that encumber your progress during this stressful time encouraging a successful work-life.

Help beat COVID-19 and go electronic!

Ready to leave Paper behind? Covid-19 Exposes the Need for Quality Software Solutions

Ready to leave Paper behind? Covid-19 Exposes the Need for Quality Software Solutions

Written By: Cynthia Gross, Product Director

PSC Software understands the business challenges companies of all sizes are facing. Forced remote working during the Covid-19 is pandemic affects the way all companies operate.  If your quality management system is paper based or you need to move to an electronic Quality Management System, this can place additional pressure on your team. PSC Software has solutions to keep you compliant and productive in this unprecedented business climate. To help companies respond to these challenges as quickly as possible we have launched ACE Essentials™, the turnkey eQMS solution!

The ACE Essentials™ Electronic Quality Management System software includes the following:

  • -Document Management
  • -Training Management
  • -Quality Management

ACE Essentials™ features:

  • -Pre-configured workflows based on best practices
  • -Over 50 SOPs, Policies and Forms
  • -Self-learning training with step by step videos
  • -Ability to implement quickly
  • -IOPQ Validation included
  • -Technical support and perpetual updates

Please stay healthy and safe during the current pandemic, and contact us for a demonstration to take advantage of ACE EssentialsTM, the easy to use, full-featured eQMS solution.

PSC Software™ Launches ACE Essentials™, The Complete Turnkey Quality Management System for Startups

PSC Software™ Launches ACE Essentials™, The Complete Turnkey Quality Management System for Startups

Pomona, Calif. October 15, 2019 – PSC Software™ announced today the release of ACE Essentials™, the complete turnkey electronic quality management system (EQMS) created for all highly regulated industries. This EQMS comes equipped with all the necessary standard operating procedures (SOPs) so you have a fully compliant quality management system from day one at an unbeatable price.

ACE Essentials™ was created to serve a multitude of industries: medical device, biotechnology, pharmaceutical, biopharmaceutical, food, active pharmaceutical ingredients, cannabis, nutraceuticals, and cosmetics. ACE Essentials™ workflows and procedures are wholly compliant with global regulations, and all updates are included in the annual price.

Charles Heldebrant, CSO of PSC Software™, says, “As a veteran in the life science industry, I understand how important it is to start off on the right foot, so I’m very pleased we are able to offer this product to those looking to accomplish that.”

ACE Essentials™ includes document management; training management; deviation, investigation and CAPA management; design control; risk management capabilities; and much more. ACE Essentials™ mitigates any future acquisition delays and regulatory body mishaps.

Brandon Clough, director of operations for the Midwest U.S. for PSC Biotech™, adds, “We’re excited to offer software that allows startups to build their quality programs quickly, with a near zero learning curve; all the while staying compliant.”

For a free demonstration or to learn more about ACE Essentials™, please contact Robert Kum at rkum@biotech.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

olepore@biotech.com

+1 (617) 803-9193

 

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