PSC Biotech Corporation Launches Revamped Website

PSC Biotech Corporation Launches Revamped Website

PSC Biotech™, a leading technology-driven life-science consulting company is proud to announce the launch of its newly-redesigned website. It features a streamlined modern design, improved functionality, and easy access to essential information to help prospective clients make well-informed decisions about their company that will fit all their needs. The new website encompasses all that PSC™ has to offer – including software, professional services, equipment rentals/sales, and exciting job opportunities into one, comprehensive site.

“We are thrilled to debut our new company website to our clientele and partners who are looking to understand the breadth of PSC™ products and services,” says Brandon Clough, Director of Business Development & Operations. “This website redesign truly ties together all of our offerings into one place and allows for each visitor, whether they are working remotely on their phone or at home on their computer, to have the same user-friendly experience. The new website allows all visitors to easily access information about PSC™’s professional services, software offerings, and contract manufacturing expertise all in one spot.”

The PSC™ marketing team continues to work on making the website modern and keeping it up to date as your go-to source for life science solutions. PSC™’s new website will be continuously-updated with the latest service and software updates, essential client/field information, and corporate milestones. Visitors and employees are encouraged to explore the website and follow us on social media for the latest. As we move forward, we will continue to make improvements on our career page to allow job seekers to sort available career openings and to filter to their specific country, state, area of expertise and more.

The new site was built by PSC™’s new Senior Marketing Specialist, Kelsey Quargnenti, with the help of the web-development team to generate high-quality content. Kelsey came to PSC™ as a multi-disciplinary graphic and web designer who delivers creative and engaging solutions across multiple brand-identity platforms including print, packaging and digital media. Kelsey’s passion for creativity and marketing is accompanied with the thrill of production: “I crave creating visual concepts that communicate ideas to inform, to motivate and to inspire,” says Kelsey. “It’s truly what I love to do!” When she’s not working on captivating the next set of potential customers, Kelsey enjoys traveling, staying active with her dog and seeking-out her next foodie adventure. 

Connect with PSC™ on social media: LinkedIn, Facebook, YouTube, Twitter and Instagram.

Contact:

Kelsey Quargnenti
kquargnenti@biotech.com (best way to contact)
(314) 599-2950

 

PSC Software™ Has Developed a New Functionality in Our Industry Leading Real Time Inspection Management Software, ACE Inspection™, to Facilitate Remote Inspections and Audits.

PSC Software™ Has Developed a New Functionality in Our Industry Leading Real Time Inspection Management Software, ACE Inspection™, to Facilitate Remote Inspections and Audits.

Dear Life Sciences Industry, 

As of March 18th, 2020, the FDA suspended routine onsite domestic inspections until further notice in response to the COVID-19 pandemic. The FDA has signaled that they will implement alternative methods in order to continue inspections, including using remote applications. FDA will be releasing a revision to their Inspection Manual to address their remote inspection procedures and requirements. 

PSC Software™ recognizes the urgent need to continue both FDA inspections and other audits for our clients allowing your products to progress through the regulatory approval process while maintaining compliance. With this shift in how inspections will be performed, PSC Software™ has developed a new functionality in our industry leading real time inspection management software, ACE Inspection™, to facilitate remote inspections and audits. 

ACE’s Virtual Inspection Management functionality, currently slated for release in July 2020, will allow inspectors and auditors to securely and remotely view your records and documents in response to an inspection request record created in the ACE Inspection™ software. 

Once the inspection request record has been reviewed and reaches the proper status, ACE Virtual Inspection Management will allow the inspector to view the approved document and limited metadata associated with the document, through an encrypted viewing portal. This portal will have permissions that will give you the ability to: 

1. Limit permissions for the Inspector/Auditor, e.g. view only, download or other permissions. 

2. Set a timeframe of access for the inspector/auditor to the portal. 

3. Limit the metadata that will be visible to the inspector/auditor. 

If you would like more information regarding ACE Inspection’s Virtual Inspection Management capabilities, please reach out to PSC Software at sales@pscsoftware.com. 

Thank you, 

Tyler Howard 

Senior Manager, Business Development 

thoward@biotech.com

(928) 308-9905

PSC Biotech™ (“PSC”) is Partnering with the Biotechnology Innovation Organization (BIO) to Provide Members Exclusive Cost Savings on Electronic Quality Management System Solutions and Computer System Validation Services

PSC Biotech™ (“PSC”) is Partnering with the Biotechnology Innovation Organization (BIO) to Provide Members Exclusive Cost Savings on Electronic Quality Management System Solutions and Computer System Validation Services

PSC Biotech™ (“PSC”), a global life sciences software solutions and consulting company, has partnered with the Biotechnology Innovation Organization (BIO) to offer members exclusive discounts on their industry leading software solutions and professional services.

PSC will be providing BIO members discounts on their software solutions – Quality Management: Adaptive Compliance Engine® (ACE) and Auditing: AuditUtopia® – as well as professional services:

  • ACE EssentialsThe pre-configured, ready-to-use, cloud-based quality management software solution for life science and biotech companies and startups. ACE Essentials is a turn-key solution that comes with pre-configured, validated workflows and includes a wide range of procedures to get your business up and running quickly in a regulated industry.
  • ACE is the single-platform, workflow based, scalable, 21 CFR Part 11 compliant, highly-configurable Adaptive Compliance Engine® driven enterprise quality management system that adapts to your business processes and provides real-time tracking, management, and reporting of all compliance, quality, and operational activities.
  • AuditUtopia® is the world’s best real-time, cloud-based inspection management solution for any inspection. Choose PSC’s easy to learn and easy to use AuditUtopia® as your inspection team’s tracking and management tool .
  • Computer Systems Validation (CSV) and Computer Software Assurance Services: PSC provides Computer System Validation and Computer Software Assurance professional services for hardware, software and computer systems to ensure full compliance with FDA and EMA guidelines. We are experts in integrating and validating existing systems to improve efficiency across sites. PSC Biotech consultants can validate your systems, be they ERP, QMS, LIMS, CTMS, AERS, DCS, PLC, BMS, VMS or a custom system.

“PSC Biotech understands the need of moving from paper-based systems to electronic systems while having everything integrated to ensure that your business is seamless and efficient” said Brandon Clough, PSC’s Senior Director of Business Development and Operations. “We see this partnership as a great way to provide BIO members, solutions and services at a discounted rate to help accelerate and ensure their success.”

“BIO Business Solutions carefully considered partners for this critical category based on the advice of our Advisory Board and has thoroughly evaluated the leading providers” said Kelly Martin, Vice President, Business Strategies. “PSC stood out, not only for their industry leading software, services and exclusive BIO discounts, but also for their commitment to working with BIO and our members. We were extremely impressed by their professionalism and client focused attitude, which will provide tremendous value to BIO member companies.”

BIO is the world’s largest trade association in the biotechnology industry sector. They represent biotechnology companies, academic institutions, state biotechnology centers and related organizations in the US and around the world. The partnership will allow members of BIO to access exclusive deals on software solutions and professional services.

A BIO membership provides cost savings on PSC’s CSV Professional Services and PSC’s software solutions, ACE™ the Adaptive Compliance Engine®, ACE Essentials, and AuditUtopia®.

Connect with PSC on social media: LinkedIn, Facebook, YouTube, Twitter and Instagram.

Contact pscbio@biotech.com for further information.

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.

 

 

 

How Computer Systems Validation Can Make or Break Your Business

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

 

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