PSC Software™ Announces the Release of Microsoft Office 365 Integration in Adaptive Compliance Engine® (ACE®) Version 3.5.0.

PSC Software™ Announces the Release of Microsoft Office 365 Integration in Adaptive Compliance Engine® (ACE®) Version 3.5.0.

Written By: PSC Software™ Business Development and Marketing Teams

PSC Software™, a wholly owned subsidiary of PSC Biotech Corporation, is pleased to announce the integration of Microsoft Office 365 with Adaptive Compliance Engine® (ACE®) version 3.5.0. ACE® is an industry leading single platform solution for all facets of a company’s quality and regulatory management needs including: Document Management, Learning Management, Quality Event Management, Inspection Management, Supplier Management and Product Life Cycle Management. To meet the evolving needs of our clients, ACE® is a cloud-based software as a service (SaaS) solution that can be accessed on any device with internet connection.

ACE® v3.5.0 enables controlled documents to be written dynamically without leaving the software. In addition to dynamic writing, teams can now collaboratively edit and comment on the draft document to further streamline the document writing process. Once editing is completed, with one click, the revised document is published in ACE® as the latest version.

Other features included in this integration release are:

  • Risk Management Module – Creation of Qualitative and Quantitative Risk Matrices
  • PDF Rendition Download Restrictions – Limit Viewing, Printing, and Modifying of PDF Renditions
  • Major Enhancement to Learning Management Module – Course Catalogs and Waiving Course

For more information, contact sales@biotech.com or click the link below to request a free demo.

Latin America Expansion

Latin America Expansion

We’re growing! At PSC Biotech Corporation, we take great pleasure in announcing that, in light of our remarkable continuous growth over the last several years, we are expanding our operations: In conjunction with our business divisions in the US, EU, China and India, we are happy to announce the creation of our new Latin America business division to better serve the needs of our existing and future customers in the region. We will now be providing our premier professional services—including our impressive portfolio of innovative products and services and novel quality software solutions—to the pharmaceutical and medical devices manufacturing industry in Latin America. For more information about our company and products, please visit our webpage www.biotech.com. We look forward to continuing our business growth and better supporting our present and future customers and business partners. 

PSC Biotech Corporation Latin America Division 

Jorge Sugranes – Latin America Regional Director, Dallas TX jsugranes@biotech.com

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.