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!

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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!

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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!

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Computer System Validation: An Overview

Computer System Validation: An Overview

Computer System Validation (CSV) is the validation process used in regulated industries throughout the world to verify that a computerized system performs as it is designed to and that it maintains the  integrity of its data to ensure the safety and effectiveness of the product. In the United States, the Food and Drug Administration requires regulated companies to perform validation of computerized systems that operate or support the production of the regulated products, including Pharmaceuticals, Biologicals, Medical Devices, Infant Formulas, Blood and Blood Components, Human cell and tissue products, etc.

Perform CSV when implementing a new computerized system or when you make a change to a validated computerized system. CSV processes are validation processes, based on applicable regulations and guidance documents, industry best practices, and the intended use of the computerized system being validated. In this post we are going to discuss a few best practice recommendations for effective, risk-based CSV.

Computer System Validation 101

FDA defines software validation as “Confirmation by examination and provision of impartial evidence that software specifications follow user needs as well as proposed uses, and that the precise requirements implemented through software can be consistently achieved.”  In the FDA regulated world, a “computer system” is not just the computer hardware and software, but the entire system, including any equipment or instruments connected to the system, as well as the actions of the users that operate the system, and the Standard Operating Procedures, manuals, and documentation.

CSV ensures that both new and existing computer systems are suitable for their intended use(s), produce correct and trustworthy results that enable regulatory compliance, meet the User Requirements Specifications, maintain required audit trails, and provide the ability to detect invalid or altered records.

The CSV process uses a variety of static and dynamic testing activities that you should conduct throughout your entire software development lifecycle, from system conception to retirement.  You should plan to validate that your system will work in all the situations that you want the system to work in.  Write a CSV Master Plan.  Document your CSV processes.  If you didn’t document your CSV, your CSV didn’t happen.

Plan your CSV activities using some or all of these elements based on your particular computerized system and its intended use(s).

System inventory and assessments determine which systems need to be validated.

System boundary documents determine where your computerized system starts and ends.

Validation plans define the purpose, scope, and plan for the validation study.

User requirement specifications explain what the system should do. For example, “I want to drive 6 people from Reno to Las Vegas (438 miles) in not more than 7 hours”.

Functional need specifications explain how the system will look and function for the user to be able to achieve the user requirements. For example, “The vehicle speed has to be at least 80 miles per hour.”

Validation Risk assessments analyze the failure scenarios in order to determine the scope of validation efforts. For example, “Speeding ticket, flat tire, etc.”

Validation Traceability Matrix references each specification to one or more specific validation tests in the Installation, Operational, and Performance Qualifications.

Network and Infrastructure qualification verifies that the infrastructure, hardware, and software supporting the application system being validated have been installed properly and are working correctly.

Installation Qualification Protocols, Test Scripts, and Final Reports demonstrate that the system has been installed correctly in the user environment.  For example, “What kind of car did I buy?”

Operational Qualification Protocols, Tests Scripts, and Final Reports demonstrate that the various functions of the system do what they are intended to do in the user environment. For example, “Do the tail lights work?  Do the brakes work?, Can I do at least 80 miles per hour?, etc.”

Performance Qualification Protocols, Test Scripts, and Final Reports determine that system does what it is intended to do along with qualified people following SOPs in the production environment even under the worst case. For example, “I drive me and 5 ‘people’ from Reno to Las Vegas.  Did I make the trip in less than 7 hours?”

Validation Reports include reported results, deviation resolutions, and conclusions of all activities in the validation study.

System Release Documentation documents that validation activities are completed, that the system was released by the authorized quality function, and the system is available to use.

The Impact of Computer Software on Biotech Industry

The Impact of Computer Software on Biotech Industry

The impact of computer software on Biotech and medical industry is immense. Thanks to the advanced technology, we can rely on computer software to design experiments, interpret data, store data, and provide results. There are several types of software, including product specific software, laboratory management software, and software for bio-imaging. When it comes to considering new Computer Software for Biotechnology, it is highly important to investigate its compatibility of operating systems, drivers, and instrument components. Computer software can go outdated quickly, so look for its ability to upgrade.

The IT department in an institution may need a consultation to integrate new technology into laboratory information systems. It would be beneficial to look for the companies that provide friendly technology support to help you get your new system up as well as running.

Biotechnology Software in the Digital Age

The digital revolution has taken place everywhere, and biotechnology companies have also adapted it. There are a number of pharmaceutical, biotechnology, and industrial bio-production companies believe that computer software must be developed and maintained in-house so that the data can be safely stored on their internal servers than on the cloud. In fact, most of the reputed companies continue to employ large IT and software teams in order to obtain computational infrastructure in the form of in-house servers. This is because of the fear of the cloud not appropriately protecting their in-house resources and the belief that their software is precious IP.

Over the past years, the ability to adapt to the changing conditions of the market will become a compelling competitive benefit. Biotechnology companies that do not adapt to the new changes may lose on key business metrics, including capital, revenue, profitability, and market share as well.

Biotechnology – Introduction

Biotechnology is an industry prime for disruption for several reasons, including

    1. It is growing frequently with rapid IPO activity, which makes a market entrance for small start-ups with venture capital backing a high probability.
    2. The tools and techniques are highly advanced with the price of reading as well as writing DNA falling faster than Moore’s law predicts.
    3. Rising levels of investment in biology bring the size of Series B rounds to $50 million. It allows small companies to enter the space with completely automated laboratories as well as production capabilities.
    4. It increases the availability of affordable infinite computing capacity that removes the need for expensive, on-site infrastructure.

Software in Research & Development groups is covering behind the existing technology landscape. Industries employ smart people, pay them money, and provide poor tools to meet their design work. In many cases, a scientist works the applications that are less innovative, less protected, and deliver an inferior user experience as compared to the applications this same scientist can provide with advanced tools and technology. Talking about biotechnology, operations in most large and even small biotech companies are fully automated pipeline. Computer-aided manufacturing (CAM) for biology is solved.

The level of automation in the pharma laboratory matches advanced manufacturing facilities like those in the automotive world, and they can get the advantage from software advances in the computer-aided manufacturing world for over 40 years. Instead of developing software in-house, companies prefer to use off-the-shelf design and infrastructure management software for their automated lab designs and their factories as well as production centers. In addition to the biotech industry, just as all industries will be computer software over the next decades. And, they may not end up with data leaks, massive and expensive software teams, scientists, and senior management team wondering how they lost.

How Computer Systems Validation Can Make or Break Your Business

How Computer Systems Validation Can Make or Break Your Business

What Is Computerized System Validation (CSV)?

Computerized System Validation (CSV) is defined by the FDA as “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled” – General Principles of Software Validation: Final Guidance for Industry and FDA Staff.”

In layman’s terms, CSV is the line of work where regulated companies validate their software applications by executing different validation projects in order to prove their software is working properly.

Why Is Computerized System Validation Important to My Business?

There are many reasons as to why Computerized System Validation is important, especially if you work in a highly regulated industry. If your business does fall into that category, it is likely you’re familiar with the validation of methods, processes, equipment or instruments to ensure your science is of high quality. CSV is no different. CSV is integral to ensuring the quality and integrity of the data that supports the science.  If the FDA or any other regulatory body inspects your company, you can guarantee they will check on this.

Common Computerized System Validation Mistakes

The whole goal of CSV is to prove that computers and software will work accurately on a consistent basis in any situation as it complies with relevant regulatory bodies.

The timeline of CSV testing activities is never ending. CSV happens throughout the whole software development lifecycle (SDLC) – from system implementation to retirement.

With that being said, this leaves ample opportunity for error. Some of the more common ones in the industry include:

  1. Poor Planning – We run into poor planning issues when there are insufficient resources and inaccurate timelines.
  2. Inadequate Requirements – Typically, we see too few, too many, too detailed, or too vague.
  3. Test Script Issues – This is commonly seen with execution errors, inadequate testing, poor test incident resolution, over reliance on vendor testing.
  4. Project Team Issues – Associated issues include poor buy-in from all stakeholders, unavailability of key personnel at key times.
  5. Inadequate Focus on the Project – Resources often are pulled off to their day jobs, insufficient managerial support.
  6. Wasting Time on Low Value Testing Activities – There are typically inadequate risks and critical assessments.

 

 

 

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.

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