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
“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
PSC Software was created to address the needs of regulated industries such as Biotechnology, Pharmaceuticals, Medical Devices, Diagnostics, Cosmetics, Blood Banks, Tissue Banks, Banking and other Financial Institutions, Nuclear Power Plants, Occupational Health and Safety Departments for Manufacturing Companies, Environmental Compliance, and Social Responsibility for corporations that must maintain compliance in these highly regulated industries. PSC Software was funded on the principle that software should not be expensive, hard to use, or complex to learn to provide a competitive advantage to our customers. Continue reading
Audit Utopia™ is the real-time inspection management system for tracking and managing audits. Audit Utopia™ tracks absolutely everything – inspections, requests, reports, and metrics. Continue reading
PSC Software will gladly allow our Clients to try any of our software products absolutely free for 30 days! We want our Clients to feel comfortable purchasing our software products, so we let them evaluate the software for themselves, so they can be sure our products suit their company’s needs. To access a free trial, please feel free to contact us.
We don’t just claim we develop helpful, powerful, easy to use software, our Clients do also. This is what one of our Clients has to say about Audit Utopia™:
“I just want to express my appreciation for your impressive Audit Utopia™ program. During a recent PAI inspection from the FDA we were challenged with 211 requests for documents. I don’t know how we would have managed without the Audit Utopia software. Continue reading
Two international biotech companies leveraged each others successful audit management experiences to improve their own. Audit readiness became an important focus for the Quality department of a multi-national vaccines and diagnostics company.
Crucial to their audit readiness plan was leveraging technology for audit preparedness. In analyzing their current processes and systems employed, the QA Director became aware that their current audit readiness plan, a paper-based system for managing regulatory and internal audits and an online chat system, was time consuming, inefficient and unproductive. Without an improvement in the information flow, they would continue to be dependent on skilled, valuable people to orchestrate the process.