POMONA, Calif. – PSC Biotech Corporation and PSC Software, a wholly owned division of PSC Biotech Corporation, is pleased to announce that its cloud-based enterprise quality management software is now used by three of the four largest health care companies in the world. Continue reading
PSC is a people-oriented company; putting great value on personal and business relationships. Our people are our valued asset. We are looking for individuals with a passion to learn new things. With a large variety of positions and locations all around the world, you’re sure to find the perfect position. Check out our job listings and apply now! Continue reading
Auditca™ is an audit report generation tool for auditors in regulated environments. Auditca™ streamlines the audit reporting process making the auditor’s work easier and quicker. Users can generate PDF reports within Auditca™, review previous drafts of the reports and get the reports authorized using Auditca™’s new electronic signature feature. Continue reading
Below is a preview of the introduction of PSC Software’s first White Paper. To read the rest of the White Paper contact us here!
Inspections are on the rise. There are a variety of reasons for this trend, ranging from specific industry trends (such as ISO certification) to globalization of the industry. Additionally, the development of counterfeit products has risen sharply, and following the Heparin catastrophe, the concern for animal-derived materials has become of paramount concern in the biotech arena. Companies are seeking to achieve a competitive advantage through accreditation, and regulatory inspections have become more frequent and more comprehensive. Developing countries that in the past have relied upon FDA and EU licensure are now sending their inspectors out on international inspections. Continue reading
PSC Software products are never complete. Our software development team is always looking for ways to improve the products they create. We use agile scrum methodology to create our software, a process that involves adapting our products through collaboration with our Clients. A major part of the development process at PSC Software is customer feedback; we would love to hear anything from a feature request to a suggestion on how to improve usability. We truly encourage our customers to provide us with feedback, so that we can improve our software products to even better serve our clientele. Continue reading
“Quality is like our health, we tend to take it for granted, and only notice it when it fails. As we are seeing it only takes one small error to have a massive disaster.” – Sipho Tjabadi
I just returned from the ASQ Audit Division Conference 2012, and I walked away with one overarching message: it’s not the cost of quality, it’s the cost of poor quality. This is a new way of looking at quality assurance. Instead of focusing on the costs of testing and validation, focus on the costs of producing a failing product. Continue reading
Cloud hosting is a new technology that PSC just employed to make our products even easier to enjoy for our customers. When PSC hosts your software in the cloud there are no installation disks or confusing manuals; we will have your application live and licensed instantly. The best part about the cloud is your company’s ability to access data and systems anywhere in the world securely. Additionally, backups are performed daily, so if your system ever becomes unavailable, a recovery instance is always ready with no effort required from you. Never buy hardware that becomes out of date; stay updated with the latest, fully validated versions of our software, giving you the benefit of the new advances.
“To be effective, audits must be focused and carefully planned, and when carried out well, can be rewarding for both the auditor and the auditee.”
Probitts, Jane, 2000 3(1), 3-6, The Regulatory Review
During an inspection, the firm does not stop operations. The maintenance personnel are fixing leaks, checking gauges and performing routine maintenance. The calibration personnel are calibrating instruments, and the operations personnel are busy making the product. In order to minimize the impact of the inspection on routine operations, it is the responsibility of the audit manager to coordinate the scheduling of these people, and to effectively organize the audit agenda. Continue reading
A database which captures, tracks, sorts, and reports audit requests is of immense value to any audit management team. Audit Utopia ™ is web-based, real-time inspection management software which accomplishes all of the above, and is 21 CFR Part 11 compliant. As a request is made, it is entered into a field and automatically date stamped, numbered, and identified by inspector. The support room is notified of a new request by an audible tone, and is able to immediate begin the process of preparing the document, and notifying the presenter of the request. The screen with all of the details of the request is then printed in the support room and attached to the document, thus providing an immediate summary of all of the critical request information as a cover sheet on the document. Continue reading
Global clarification and escalation of pharmaceutical regulations has resulted in increasingly complex audits. Audits today are more frequent, longer in duration, and deeper in scope, which results in amplified challenges for effective audit management. The outcome of the audit is often influenced by the firm’s ability to effectively manage the audit. An audit with a poor outcome can have major affects on a company. Continue reading