Compliance Made Easy With PSC Software® Solutions.

Streamlining Compliance with Innovative Solutions

PSC Software®'s solutions help businesses speed up their time-to-market while keeping costs low and maintaining quality and compliance. PSC Software® offers a wide array of comprehensive solutions for businesses in highly regulated industries to stay ahead in today’s competitive marketspace.

Solutions

Accelerate Your Business with PSC Software®'s Solutions

Stay ahead of the competition with PSC Software®'s industry-leading solutions.

Boost your company!

PSC Software® offers cost-effective solutions with excellent technical capabilities and industry leading customer service. Our solutions are fully adjustable to the needs of our clients. No project is too large or small.

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INDUSTRIES WE SERVE

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Solutions
Biotech/Pharma

PSC Software®’s eQMS solutions have been tailored to meet the demands of the biotech and pharma sectors, with compliance at its core to ensure all regulatory requirements are met and quality control is upheld. Streamline processes, organize documentation with ease, and automate tedious tasks such as change requests, deviations and non-conformances. Our eQMS solutions enhance collaboration across teams and departments while permitting real-time access to data for improved decision-making. Through these software solutions, biotech and pharma companies can ensure efficiency while reducing risk levels – all without compromising on the high-quality standards necessary for success in this industry.

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Medical Devices

PSC Software®’s eQMS solutions are specifically designed to cater to the regulatory requirements of the medical device industry. With a robust and comprehensive quality management system in place, organizations can streamline their processes, reduce errors, and enhance compliance with regulatory standards such as FDA 21 CFR Part 11. Our eQMS (electronic Quality Management System) is designed helps businesses manage all aspects of their operations including quality control (Non-Conformance, CAPA, Deviation), document control, learning management, inspection management, risk management, supplier management, and much more. PSC Software®’s eQMS solutions enable transparency across the organization by providing real-time visibility into critical KPIs and metrics through fully customizable dashboards. This data-driven approach empowers executives to make informed decisions based on accurate information. Moreover, PSC Software®’s eQMS solutions are scalable and adaptable to meet an organization’s specific needs – whether it be for small medical device manufacturers or large multinational corporations operating globally – ensuring that they stay ahead of the curve in this dynamic industry.

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Clinical Research Organization

PSC Software®’s eQMS solutions are a game-changer for clinical research organizations. With the increasing complexity of regulatory requirements in the industry, companies need to ensure that their processes and data management systems comply with these regulations. That’s where PSC Software® comes in – their advanced technology enables businesses to automate and streamline their quality management system, ensuring compliance at every step along the way. By leveraging PSC Software®’s solutions, clinical research organizations can increase efficiency across all aspects of operations, from document control to risk management to vendor oversight. This translates into cost savings and more importantly, faster delivery of innovative treatments to patients who need them most. Furthermore, PSC Software® offers comprehensive training programs that empower employees with knowledge on best practices for managing quality within a regulated environment – this ensures staff are equipped with the skills they require while reducing human errors which can lead to costly mistakes or delays down the line. Ultimately, partnering with PSC Software® helps transform clinical research organizations into agile enterprises that are better positioned than ever before to deliver high-quality outcomes while remaining compliant with regulatory guidelines.

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Solutions
GLP Laboratory

When it comes to GLP laboratories, maintaining compliance with strict regulations is of utmost importance. PSC Software®’s eQMS and inspection management solutions can help these laboratories streamline their processes and ensure that all data is captured accurately and securely. Having an eQMS allows GLP laboratories to easily manage their documentation, track deviations from standard operating procedures, and maintain a complete audit trail. Additionally, PSC Software®’s inspection management tool helps these labs prepare for inspections by providing real-time visibility into compliance status across all locations. This ensures that any potential issues are identified and addressed before an actual inspection takes place. PSC Software®’s eQMS and inspection management solutions provide GLP laboratories with peace of mind knowing that they have the tools necessary to comply with regulations while efficiently running their operations.

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CDMO/CMO

In the highly regulated pharmaceutical industry, compliance is paramount. PSC Software® offers comprehensive eQMS and inspection management solutions so that contract development and manufacturing organizations (CDMOs) remain both competitive, and compliant with ISO and FDA regulations. The integrated approach behind these tools ensures an efficient workflow that encompasses all quality processes from beginning to end. Additionally, our eQMS solution allows CDMOs to manage CAPA, deviations, non-conformance, documents, training, product life cycles, risk, audits, and more in a single centralized location. Our inspection management solution takes this further by providing an integrated approach that not only facilitates inspections, but also helps companies prepare for inspections with audit trails capturing every step of the process. By combining these two solutions together, CDMOs are able to streamline compliance efforts for better productivity without compromising on quality assurance efforts over time. This combination improves efficiency while increasing transparency throughout all stages of drug development and manufacturing – essential components in meeting regulatory standards today.

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Compounding Pharmacies

PSC Software®’s eQMS and inspection management solutions are a game-changer for compounding laboratories. With the increasing demand for customized medications, these labs must ensure that their products meet the highest standards of quality and safety. PSC Software®’s eQMS solutions offer a centralized platform to manage all aspects of laboratory operations, including document control, change management, deviation tracking, CAPA management and much more. By automating these processes, compounding laboratories can eliminate manual errors and reduce the risk of non-compliance issues. Additionally, PSC Software®’s inspection management tool simplifies regulatory inspections by providing an organized system for managing documentation and preparing reports. PSC Software® helps companies integrate quality processes across all departments in order to improve operational efficiency while reducing risks associated with non-conformance or deviations from established standards. PSC Software®’s eQMS and inspection management solutions provide comprehensive support to compounding laboratories looking to enhance their compliance capabilities while streamlining their operations towards improved patient outcomes.

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Solutions
Converting Your Paper Based QMS to an eQMS

PSC Software® offers a powerful solution for companies looking to transition from paper-based quality systems to an Electronic Quality Management System (eQMS). With its user-friendly interface and comprehensive feature set, ACE® (Adaptive Compliance Engine®) enables organizations to streamline their quality processes while ensuring compliance with industry standards and regulations. By centralizing all quality-related data in one location, the software eliminates the need for manual record-keeping and reduces the risk of errors or oversights. In addition, PSC Software’s eQMS provides real-time visibility into key performance metrics, enabling managers to make informed decisions based on up-to-date information. Whether you’re looking to improve efficiency, reduce costs, or enhance your overall quality management program, ACE® is a valuable tool that can help you achieve your goals with ease.

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Becoming Audit Ready

PSC Software® can help companies become audit ready by providing comprehensive compliance management solutions. With its user-friendly interface and advanced features, ACE® simplifies the process of maintaining audit readiness by providing quality management, inspection management and more. Companies can take advantage of the solutions PSC Software® provides to manage their regulatory requirements, track compliance activities, and generate reports for audits. Keep accurate records of regulatory compliance efforts on a centralized platform to ensure efficient and effective preparation for potential inspections. Workflow automation capabilities enable users to streamline processes such as change management, record tracking, and quality events such as CAPA and Deviations. PSC Software® provides companies with peace of mind knowing they have a solution that enables them to be fully prepared for audits at any time — making sure everything aligns perfectly when auditors come knocking at your door!

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Post Market Quality Assurance

PSC Software® provides a powerful product-lifecycle management solution that can significantly aid in post-market quality assurance. PSC Software®’s product lifecycle management solution’s advanced features and functionalities enables manufacturers to keep track of their products’ performance in the market and identify any potential defects or issues. By using ACE PLM®, companies can collect data on customer complaints, adverse events, and other feedback sources to analyze trends and patterns. This information allows them to make informed decisions about product improvements or recalls if necessary. ACE PLM® can be used to generate customized reports that provide comprehensive insights into each product’s quality metrics at various stages of its life cycle. These reports help manufacturers identify areas for improvement while also providing evidence-based documentation that ensures regulatory compliance. ACE® streamlines communication between different departments within an organization, making it easier to share important information related to post-market quality assurance among stakeholders such as sales teams and management personnel. Taking advantage of PSC Software®’s powerful solutions can improve your organization’s efficiency and the reliability of their post-market quality assurance process while ensuring consumer safety remains the top priority throughout every stage of a product’s lifecycle.

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Preparing Regulatory Submissions

PSC Software® plays a crucial role in preparing for post-regulatory submissions by providing comprehensive tools and resources that streamline the regulatory process. With its advanced analytics capabilities, PSC Software® can analyze complex data sets to identify potential compliance issues before they become problematic. This ensures that all required documentation is complete and accurate, reducing the likelihood of costly delays or rejections during the submission process. Additionally, PSC Software® offers real-time updates on changing regulations, enabling organizations to remain up-to-date with evolving standards and requirements. By leveraging this technology, companies can save time and resources while ensuring their products meet all necessary regulatory guidelines. PSC Software® offers essential tools for any organization seeking to navigate the complex world of regulatory compliance with confidence and ease.

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Solutions
Accelerate Time to Market

PSC Software®, with its advanced tools and technologies, can significantly accelerate the time to market for a product. By leveraging automation and streamlining the design process, PSC Software® enables engineers to develop products faster without sacrificing quality. The keyword here is “automation,” which plays a crucial role in optimizing various stages of the product development cycle. From concept ideation to prototyping and testing, PSC Software® automates several tasks that would otherwise require significant manual intervention. This reduces human error and frees up valuable time that can be utilized for more critical aspects of product development. Additionally, PSC Software® also facilitates collaboration among cross-functional teams by providing them with real-time data insights into the status of each stage of development – enabling quicker decision-making and reducing delays caused by communication gaps or misaligned objectives. Choosing PSC Software® helps businesses speed up their go-to-market strategies while keeping costs low – making it an essential tool for companies looking to stay ahead in today’s competitive marketspace.

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Solutions
Unifying Your Documents, Trainings, & Assets

As businesses grow, they often struggle with managing and unifying their vast collection of documents, trainings, and assets. That’s where PSC Software® comes in. With its advanced cloud-native solutions, PSC Software® helps streamline document management by providing a centralized location for all types of documentation – from policies and procedures to training materials and asset records. By leveraging the power of ACE® (Adaptive Compliance Engine®), users can easily search for any document or training material they need within seconds, saving them time and boosting productivity levels across the organization. Additionally, PSC Software® provides tools that help manage assets more effectively by tracking equipment usage, maintenance schedules, warranty expiration dates, and more while ensuring optimal performance at all times and reducing costs associated with downtime or replacement of faulty assets. ACE® ensures organizations have complete control over their documents, trainings, and assets while maintaining compliance with industry standards through automated workflows and audit trails – making it the best solution for businesses looking to enhance efficiency in these areas.

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Solutions
Configuration

PSC Software® offers robust solutions designed to address the complexities of configuration management, enabling organizations to streamline their processes and achieve greater efficiency. With ACE® as a core component of its offerings, PSC Software® provides users with a comprehensive set of tools that allow them to define and manage system configurations in a highly flexible and customizable manner. Whether working with complex hardware systems or intricate software applications, PSC Software®’s configurable solutions empower teams to collaborate more effectively and make informed decisions based on real-time data. Through intuitive interfaces, advanced analytics capabilities, and robust reporting features, PSC Software® helps organizations optimize their configuration workflows from beginning to end – resulting in improved productivity, reduced costs, and enhanced overall performance.

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Validation

PSC Software®’s solutions make validation a breeze. Firstly, their electronic document management system allows for easy access to all necessary documentation and ensures that all documents are up-to-date and compliant with regulations. PSC Software®’s solutions facilitate efficient data collection, analysis and reporting through automated workflows that reduce the possibility of human error while ensuring accuracy and consistency across the entire validation process. Their software also enables real-time monitoring of critical processes, allowing for prompt identification of any deviations from expected results or parameters. PSC Software®’s solutions provide project management tools that help streamline communication between teams involved in the validation process by enabling remote collaboration on tasks in real time. PSC Software’s suite of solutions significantly enhances efficiency and expedites the validation process while maintaining compliance with regulatory standards related to business operations.

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Data Migration

PSC Software®’s solutions are designed to simplify and streamline the process of data migration. With advanced features such as automated mapping, data profiling, and validation tools, our software can help organizations easily migrate large volumes of data from one system to another with minimal disruption or downtime. Our data migration technology ensures that all record data is accurately transferred without loss or corruption. Additionally, our software is fully cloud-hosted and can handle complex transformations and support multiple source systems simultaneously, making it ideal for organizations with diverse IT environments. PSC Software®’s team of experienced professionals provides end-to-end support throughout the migration process; from planning and design to execution and testing. By leveraging our innovative software solutions, businesses can achieve a successful transition while minimizing risk and maximizing efficiency.

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Solutions
Project Management

PSC Software® is dedicated to meeting the specific needs of project management. PSC Software® offers tools for managing projects efficiently, and a wide range of tools that can be customized and tailored according to the requirements of any project. One such feature is the ability to create detailed schedules with milestones and deadlines, which helps keep everyone on track. Additionally, the software allows users to assign tasks and responsibilities easily, along with setting priorities based on importance or urgency. Another essential aspect of project management that PSC Software® excels in is communication. Communication becomes much easier too – PSC Software® provides a centralized hub for team members to collaborate by sharing documents, messages, and updates in real-time. With this feature available at their fingertips, project managers can ensure that all stakeholders stay informed about progress made so far while also tracking any potential risks. Additionally, project managers can monitor resource allocation easily using the comprehensive reporting tools provided, while tracking performance metrics and identifying areas where improvements can be made.

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Admin on Demand

PSC Software® is proud to offer Admin on Demand Capabilities to make the most of your software solution. Whether your company needs an extra hand while learning your new system or just helping with day to day tasks – PSC Software® is here to help! Our Admin on Demand System includes adding new employees to the system, creating groups and training roles, assigning training to new and existing employees, uploading first versions of documents, training new employees, setup and modification of dashboards, creation of reports, performing mass updates and much more!

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Tech Support & Maintenance

PSC Software®’s software solutions are designed to streamline tech support and maintenance for organizations of all sizes. With our innovative tools, your team can easily track issues, monitor performance, and identify potential problems. Our powerful analytics capabilities allow you to quickly pinpoint root causes of issues and make data-driven decisions to optimize your systems. Plus, our intuitive interface allows non-technical users to troubleshoot common problems with ease. Whether you’re looking to improve the speed and efficiency of your help desk or ensure that critical systems stay up and running around the clock, PSC Software® has the industry-leading solutions you need to succeed in today’s fast-paced digital landscape.

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