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

PSC Biotech Corporation Launches Website Highlighting Support Services for Highly Regulated Industries

PSC Biotech Corporation Launches Website Highlighting Support Services for Highly Regulated Industries

Pomona, Calif.. July 16, 2019 – PSC Biotech Corporation, a leading global life science support company, launched its website showcasing the company’s divisions: PSC Biotech™  consulting services; PSC Software™ audit and quality management software; and BioTechnique, its contract manufacturing facility. All divisions serve the life science industry and other highly regulated industries.

“We’re excited to have a website that intelligently represents what we do,” says John Clapham, CEO of PSC Biotech Corporation. “We hope it will expand our reach in assisting companies across the globe to achieve success.”

PSC Biotech Corporation covers a range of expertise to aid the life science industry,  from software to consulting to contract manufacturing. The launch of PSC Biotech Corporation’s website aims to cohesively and accurately represent each function of the company to communicate the support offerings to some of the world’s most life-changing companies.

To learn more, visit www.biotech.com.

About PSC Biotech Corporation

Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. PSC Biotech Corporation consists of three unique active divisions within the parent company – each representing one of our areas of expertise: our professional-service division, PSC Biotech™; our software division, PSC Software™; and our contract-manufacturing facility, BioTechnique. Each of our divisions are heavily rooted in their respective expertise areas aimed at meeting the ever-changing needs of our clients around the globe.

Media Contact:

Olivia Lepore
olepore@biotech.com
+1 (617) 803-9193

California Biotech Firm to Hire 100-plus to Make Cancer Drugs in University Research Park

A California biotech consulting firm that pledged to create at least 103 local jobs by 2017 will get a $1 million low-interest loan from the state to help it buy an under-used pharmaceutical manufacturing facility in University Research Park where it plans to make cancer-fighting and other types of drugs for other companies.

The former Mentor Biologics building, originally designed to produce an anti-wrinkle compound but never used for that purpose, had been owned by the Morgridge Institute for Research since 2010. It was sold June 30 to Pomona, California-based PSC Biotech Corp., about one year after the Morgridge Institute — a private research partner of UW-Madison — put it on the market, officials said.

A ribbon-cutting ceremony was held Thursday at the facility at 5501 Research Park Boulevard, though drug production isn’t slated to begin there until 2015.

“This is just great news, not only for the research park, but for Madison,” said Aaron Olver, the newly hired managing director of University Research Park who formerly ran economic development efforts for the city.

“They’re a perfect match for the building and its capabilities,” Olver said of PSC Biotech™. “They’re a great complement to what’s going on in the research park, and they’ll be a good resource for some of the companies in town that might want to use their services.”

PSC Biotech™ created a subsidiary known as BioTechnique to run the contract-manufacturing operation in Madison.

“We are excited by the opportunity to do our part in meeting the high demand for cytotoxic drugs and by the vast potential that this … facility brings,” PSC Biotech™ CEO John Clapham said in remarks at the ribbon-cutting.

The purchase price for the facility was not released, but Mark Maley of the Wisconsin Economic Development Corp., the state’s chief job creation agency, said PSC Biotech™ had invested $11.5 million to buy and partially equip the two-story, 37,400-square-foot building.

The $1 million loan is from WEDC’s Business Opportunity Loan Fund program. Loans are designed to fill gaps in project funding and, in the case of PSC Biotech™, will help pay for some of the needed equipment, Maley said.

About the WEDC loan, PSC Biotech™ spokesman Connor Ledbetter said, “We just saw it as a great opportunity to partner with the state and get our foot in the door with the WEDC and to help finance the acquisition.”

Situated on nine acres with room to expand, the facility offers state-of-the-art amenities for sterile, liquid-injectable drug manufacturing, including 100 advanced “clean” rooms, five air-handling units, a 1,900-square-foot quality control lab, a machine that freeze-dries liquid drugs into powder for storage and transport, and high-tech production line equipment, much of it never used.

“They’ll basically be filling sterile vials with medicine,” Olver said about the planned manufacturing operations. “This is a new growth area for the company and they picked this facility in Madison to get up and running.”

“It’s a great facility that really has yet to be put to use,” said Steve Mixtacki, chief financial officer and operating officer for the Wisconsin Alumni Research Foundation, of which the Morgridge Institute is an affiliate. “The linkage to the university and to Madison College in terms of an employment base also was attractive to the company.”

Mixtacki said Morgridge’s board of directors would meet next week to consider a resolution to use the money from the building’s sale to create an endowment supporting the research done by the Morgridge Institute within the Wisconsin Institutes for Discovery on campus. Morgridge researchers made limited use of some labs and offices in the facility — though never the production equipment — for a few years, Mixtacki said, but ended up deciding the building was not a good fit for them.

The Morgridge Institute acquired the building through a donation from health care products giant Johnson & Johnson, which purchased Mentor Biologics for $1.07 billion in 2009 but decided it didn’t need the facility, built for Mentor Biologics in 2008, to produce PurTox, a Botox-like toxin Mentor designed to erase frown lines.

Mixtacki said PSC Biotech™ was the most serious of “two or three” companies that expressed interest in the property over the past year.

It also was most familiar with the specialized facility because Mentor Biologics had hired PSC in 2008 to get the needed Food and Drug Administration approvals to use it for manufacturing.

PSC Biotech Corporation Announces Acquisition of BioTechnique™, a High Potency, Sterile Fill-Finish Pharmaceutical Manufacturing Facility from Morgridge Institute

Madison, WI – PSC Biotech Corporation announced today the acquisition of a high potency sterile injectable facility from the Morgridge Institute for Research (MIR), a private research institute affiliated with the University of Wisconsin-Madison. The contract manufacturing operation will be named BioTechnique and will be a newly formed subsidiary of PSC Biotech Corporation.

The 37,000 square foot sterile injectable fill finish facility, located in Madison’s University Research Park was constructed in 2008 by Mentor Biologics, Inc. and later conveyed to MIR.

PSC Biotech Corporation partnered with Steve Mixtacki, Chief Financial and Operating Officer of the Wisconsin Alumni Research Foundation (WARF), an affiliate of MIR, who said “…PSC has been a pleasure to work with, and we wish them much success at 5501 Research Park Boulevard”.

Additionally, PSC Biotech Corporation was very pleased with the outcome of the acquisition. “This was a great team effort from PSC to help drive future growth potentials for the company, and more importantly, help meet the high demand for cytotoxic and high potency fill-finish contract manufacturing services of sterile injectable products”, stated Raphi Hanessian, Managing Director of PSC Investments, a subsidiary of PSC Biotech Corporation. The acquisition was financed with an SBA real estate loan from East West Bank in partnership with the CDC Small Business Finance team.

The recent acquisition of the pharmaceutical manufacturing facility will allow BioTechnique the opportunity to provide specialized filling services for cytotoxic, high potency, biologic, and other sterile injectable drugs. The injectable facility is state-of-the-art for filling and finishing high potency compounds and was designed to meet the highest safety levels for manufacturing personnel, as well as to minimize cross contamination, and be compliant with current Good Manufacturing Practices (cGMP) for sterile injectable manufacturing.

BioTechnique will be customer ready for sterile liquid and lyophilization fill-finish production in 2015.

When fully operational, BioTechnique is expected to employ over 100 technical professionals in Madison, Wisconsin.

About PSC Biotech Corporation

PSC Biotech Corporation is a premier service provider of products and professional services to life science companies, helping them achieve scientific and commercial success. PSC Biotech Corporation provides a full spectrum of professional consulting services, investment advisory services, quality management systems, and contract manufacturing operations to assist our clients to achieve regulatory approval and to maintain compliance to the standards of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

To learn more, please contact:

PSC Biotech Corporation
Olivia Lepore, Marketing Specialist
Phone: (617) 803-9193
Email: olepore@biotech.com

Financed By
East West Bank
James P. Lin, Senior Vice President, Deputy Director of Business Banking
Samuel C. Li, Assistant Vice President & Relationship Manager
Phone: (626) 363-7410
Email: Samuel.li@eastwestbank.com

CDC Small Business Finance
Kurt Chilcott, CEO/President
Armen Madatyan, Senior Commercial Lender
Phone: (626) 529-0712
Email: TeamLA@cdcloans.com