Working with Life Science Companies to assure Computerized Systems Validation and Global Regulatory Compliance for over 25 years.
When working with PSC Biotech®, you can expect a seamless, FDA and EMA compliant, customized solution to all your computer systems validation needs.
With over two decades of consulting experience in the life science industry, we fully understand that computer systems are vital for a company’s success. Our specific areas of expertise within computer systems validation are included below. Developing and bringing life-changing drugs and devices to market: that’s your job. Expert computer systems validation consulting: that’s ours. You have enough to accomplish; let us be your resource for computer systems validation. As a global leader specializing in computer systems validation consulting services, PSC Biotech® works to ensure life sciences companies’ processes are functional and fully compliant with FDA and EMA guidelines. We guarantee these systems are running efficiently and accurately when you work with PSC Biotech®.
Electronic Document Management Systems
For over ten years, PSC Software® has provided cloud-based document management software for life science companies around the globe. In highly regulated industries, computer systems are used to create, modify, and maintain documents to ensure accuracy, provide access to version and approval history, allow the classification of documents by use or type, and enable the ability to discern proper access and training assignments. With PSC Software®, these processes are made simple. PSC Software® comes to you pre-validated by our CSV engineers. PSC Biotech® CSV consultants are also available to validate your existing electronic document management systems and laboratory management systems. Contact the PSC Biotech® CSV consultants for further computer systems validation integrated with equipment and other laboratory management systems.
The implementation of an Enterprise Resource Planning (ERP) system presents unique challenges as well as opportunities for companies of all sizes. ERP systems can represent a substantial financial investment, and proper planning and implementation of this foundation will provide seamless processes and insight to support strategic opportunities. PSC Biotech® Consultants will guide you through the entire process, beginning with identifying company culture roadblocks, continuing with the migration of data and resource silos, ensuring proper data security, and finally, the creation of accurate reporting.
Laboratory Equipment Software Validation
One-of-a-Kind Expertise to Address an Ever-Changing Industry
PSC Biotech® has vast experience in validating laboratory equipment software in GMP and GLP environments, recognizing the critical part these instruments play in life sciences data’s overall quality and integrity. PSC Biotech® excels in developing system inventories, performing risk assessments, determining remediation actions, and performing equipment qualification in tandem with software validation. PSC Biotech® is highly experienced in carefully leveraging vendor packages to minimize additional validation costs. Whether validating existing or new equipment software, the PSC Biotech® CSV team’s robust, risk-based approach ensures high-quality, cost-effective solutions.
Clinical Data Systems
Data integrity and data quality are of the highest importance in performing a clinical study. The computerized systems used for clinical data also need to be tested and validated according to regulatory guidelines. A clinical data management system (CDMS) manages electronic clinical trial data. The clinical trial data gathered at the investigator site and in the case report form are stored in the CDMS in the following sequence:
- Generation of source data. Includes laboratory results, clinical site medical records, and patient logs or diaries.
- Transcription of the data into Case Report Forms (CRFs). Case Report Forms can exist as either paper files or electronic files. The electronic version of the Case Report Form is called eCRF. Paper files have many manual entry steps that increase the possibility of errors.
- Data from the Case Report Forms (CRFs) are transcribed into the clinical trial database.
- Data is quality checked (for accuracy and completeness), and any issues are investigated and resolved. This usually involves communication with the clinical site.
- The database is then finalized and locked.
- The data is reformatted to facilitate data analysis. Typical formatting activities include the creation of tables, listings, and diagrams.
- The data is then analyzed, and results are compiled. Significant results may cause further data reporting activities such as tables, listings, or diagrams.
- The results from the clinical study are then integrated into deliverables such as Clinical Study Reports (CSRs) and Investigator’s Brochures (IBs) etc.
- The Clinical Trial Database and other applicable study data are retained and archived.
- This sequence can change and be modified based on the clinical study. In some cases, studies will likely report intermediate discrepancies and listings to identify problems before completing the entire clinical study.
Clinical Data Management Systems have extremely high compliance standards they must meet because of their critical role in evaluating the potential therapy’s safety and efficacy. Data integrity and data quality are of the highest importance in performing a clinical study.
When PSC Biotech® engages with a client to perform a validation of a Clinical Data Management System, it follows the FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations. This guidance characterizes data integrity and data quality for both paper and electronic clinical records using the acronym “ALCOA”:
- A: Attributable – the source of the data is known
- L: Legible – the source of data is readable and comprehensible to humans
- C: Contemporaneous – the data are recorded when generated
- O: Original – the data are the first recording from the primary source
- A: Accurate – the data are correct
Data Quality also has the following essential considerations:
- That the data is readily available, transmissible
- Storable and data are complete and unbiased
- Data are in an internally consistent format and compliant with or readily transformable to accepted standards.
How can PSC Biotech® help validate your Clinical Data Management System? PSC Biotech® can perform validation of clinical data management programs and procedures, which is required to document that clinical data management standards are met. PSC Biotech® has experience on all clinical data management systems used in the industry. Contact PSC Biotech® to learn more and get a free consultation for PSC Biotech® CSV team’s fast, budget-friendly expertise.
Computer systems used to create, modify, and maintain electronic records and manage electronic signatures are subject to validation requirements to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. PSC Biotech® CFR Part 11 compliance reviews are based on a justified and documented risk assessment and a determination of the potential for the system to affect product quality, patient safety, and record integrity. PSC Biotech® CSV consultants will work with you to review your existing validation procedures and documentation to identify any gaps in validation, define any remediation activities, and develop a training approach to ensure maintenance of compliance once our project is complete.
HVAC Commissioning, Qualification and Validation
A well-designed Heating, Ventilation, and Air-Conditioning (HVAC) system is essential in ensuring the manufacture of quality biotech, pharmaceutical, and medical device products. It will also provide comfortable and clean conditions for operators or any person in the area supplied with air from the HVAC system. Following the COVID-19 pandemic, HVAC air systems are under additional scrutiny for effectiveness and cleanliness.
For life sciences companies, the design of the HVAC systems has a direct impact on the critical cleanroom performance parameters such as room pressure differential cascades, prevention of contamination, and cross-contamination control. Good HVAC design should primarily ensure product protection, personnel protection, and environmental protection.
Commissioning activities include the testing, adjustment, and balancing (TAB) of the entire HVAC system to ensure that it meets all the requirements specified in the User Requirement Specification (URS) and stipulated by the engineer, designer, or construction company.
The commissioning documents for the HVAC system should provide documented evidence of all measured capacities of the system. The data recorded should include the design and measurement figures for airflows, liquid flows, system pressures, and room classifications, amongst other measures. The commissioning plan should start at the early stages of a project so that it can be integrated with system qualification procedures.
PSC Biotech® CQV and CSV consultants can provide commissioning support for all GxP HVAC systems, including documented measurements of main HVAC system capacities, such as:
- Verification of clean fabrication/installation
- Air duct leakage test
- Measurement of airflow
- Measurement of fluid flow (liquid)
- Test, Adjust, and Balance (TAB)
The level and extent of HVAC qualification should be described in a Validation Master Plan (VMP). The VMP will detail the specific parameters for testing and the extent of that testing. Additionally, it will define the test procedures and protocols to be followed.
Stages of the HVAC system qualification should include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Critical and non-critical parameters should be determined by utilizing a Risk Analysis (RA) for all HVAC installation components, subsystems, and controls.
PSC Biotech® has specialized experts that can perform HVAC qualification activities, including design qualification (DQ) and development of custom qualification and validation documents, and execution of all activities, together with documented measurements of critical HVAC system parameters, such as:
- Classification of air cleanliness by particle concentration
- HEPA filter certification tests
- Supply air flow rate and air change rate for non-unidirectional airflow installations
- Supply airflow velocity and uniformity of velocity for unidirectional airflow installations
- Temperature testing
- Humidity testing
- Differential Air Pressure Tests
- Smoke Testing for airflow verification and visualization
- Room disinfectant studies
- Environmental Monitoring Programs
- Room Recovery testing
HVAC Performance Qualification and Validation
Validation is a requirement of Good Manufacturing Practices (GMP) mandated by the US FDA, EMA, CFDA, KFDA, TGA, and other global regulators. HVAC Performance Qualification (PQ) focuses on how the room environment can impact the quality of the products produced in the classified cleanrooms.
Cleanrooms and associated controlled environments provide the necessary controls for potential air-borne contamination (both viable and non-viable) of air and surfaces in a cleanroom. Contamination control can be beneficial for protecting product or process integrity for the compliant manufacturing of active pharmaceutical ingredients (APIs), biologics, pharmaceuticals, medical devices, and other industries where air-borne contamination is a risk.
PSC Biotech® can help you validate your cleanroom to the following standards: EU GMP, U.S. FDA, ISO/TC, PIC/S Guides, WHO, TRS, or other regulatory requirements. We have the necessary equipment, training, and staff to perform all aspects of HVAC validation, including viable and non-viable air monitoring.
Let PSC Biotech® help you design a risk-based approach to validating your cleanrooms. We are ready to ensure that the cleanroom will perform to intended specifications, ensuring that the manufactured products will consistently and reliably meet their intended product specifications. PSC Biotech® CSV and CQV team can guide you to a successful validation effort, ensuring a positive outcome on a preapproval inspection (PAI).
PSC Biotech® computer system validation experts have experience integrating a wide range of platforms to make your processes and systems seamlessly work together to gain maximum efficiencies. PSC Biotech® has experience integrating your existing Building Management System (BMS) into your existing Electronic Quality Management System (eQMS) or Enterprise Resource Planning (ERP) system. If your organization does not have an Electronic Quality Management System (eQMS), PSC Biotech has a world-class eQMS system that will fit your needs: ACE Essentials® and ACE® from PSC Software®.
Adverse Events Systems
Adverse event planning is vital to detecting, processing, and reporting thoroughly and timely. PSC Biotech® will assist you in creating a strategic roadmap for determining what data should be collected and what processes need to be in place to ensure compliance with regulations – including definitions and approaches to define the roles, responsibilities, processes, forms, the communication of adverse events and the follow-up activities to ensure that complete information is obtained.
Material Requirement Planning Systems
When implementing Material Requirement Planning as a stand-alone system or part of a more extensive Enterprise Resource Planning System, PSC Biotech® Consultants help you avoid the pitfalls created by company culture issues, requirement planning failures, or inadequate resource forecasting needs for implementation. Whether you use Dynamic Lot Sizing, Least Unit Cost, or other models, PSC Biotech® Consultants will assist in problem areas. For example, PSC Biotech assists in identifying and remediating lead time errors, maintenance of local and distributed inventory, BOM data accuracy, and other issues by applying industry best practices to your manufacturing processes, resulting in a system for creating accurate quotes, controlling stock, purchasing of materials, resolving data integrity issues and provide accurate reporting.
Manufacturing Execution Systems
PSC Biotech® Consultants will work with you to provide insight and control of your manufacturing process, research and data analysis, equipment performance, process changes, and training requirements and tracking. As part of a fully integrated QMS, manufacturing execution systems will provide mechanisms for lowering costs through greater efficiency, identifying manufacturing and process issues to minimize the impact on development and delivery cycles. See our dedicated page on Manufacturing Execution Systems (MES) for more information.
Calibration Management Software Implementation & Validation
When performing thousands of calibrations each year, managing your calibration processes is vital to ensuring manufacturing continuity, efficiency, and compliance. Paper-based systems are prone to human error, spreadsheets and databases can’t provide insights into the data being collected, and maintenance based on recommended intervals or historical trends can result in calibration activities before or after they’re actually needed. The use of calibration management software can reduce costs, provide a more accurate analysis of historical trends, and optimize calibration intervals.
PSC Biotech® Consultants will work with you to review your current procedures and documentation, identify gaps, manage calibration management software’s implementation and validation, and develop a training approach to maintain compliance moving forward. You can be confident that processes will be in place to ensure maintenance is scheduled and performed at the proper time, communications between equipment are working correctly, and the validation of instrument measurements are maintained and documented.
Plant Maintenance Asset Management System Implementation & Validation
PSC Biotech® subject matter experts stay at the forefront of industry development and will assure your project’s success. We will share our knowledge of regulatory agency mandates to develop a quality plan specifically for you. Let us know when you need help while preparing a new building, requalifying equipment, or have temperature excursions for us to investigate.
Quality Management Systems
As manufacturing and software solutions evolve, the need for inclusive Quality Management Systems is greater than ever. For over ten years, PSC Software® has provided systematic solutions through cloud-based software for life science companies around the globe.
With an eQMS from PSC Software®, you’ll integrate the framework to support the continuous effort to improve quality through transparency of data for evidence-based decision making, alignment of your organization’s purpose and goals, and systemic approaches to improvement. The integration of Document Management, Reporting Management, Inspection Management, Audit Management, Learning Management, and Product Lifecycle Management combine to provide a robust QMS that will support compliance, profitability, and the development of a quality-driven culture. PSC Biotech® consultants and PSC Software® employees can assist you in upgrading to an eQMS in full compliance with regulatory agencies.
With PSC Biotech®, you only need one powerhouse resource for top-of-the-line Lives International® thermal validation and mapping equipment combined with expert consultants ready to shape the scope of your qualification project and ensure your success. When you consolidate with us as your service provider, we make certain that all project components are in sync: from protocol writing and validation and calibration of equipment to final report generation and review.
PSC Biotech Industry Expertise:
Pharmaceuticals, Personalized Medicine
Medical Devices, Biotechnology
Tissue Products, Cell and Gene Therapy
Food & Beverages, Homeopathic, Nutraceuticals
Our goals are to provide tailored professional services, act as a seamless extension of life science companies, assist you in producing the highest quality products possible, and ensure processes are functional and in full compliance. PSC Biotech® Computerized Systems Validation consultants work to your project needs.
To start the process of gaining a PSC Biotech® CSV consultant to design, validate, implement, optimize, review, investigate, audit, or otherwise assist in CSV, contact us today! See our success pages for examples of our CSV projects with life science companies.
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What Our Clients are Saying
“During the past year, our company has been working with PSC™ on various activities within the development and implementation of a new medical device product. PSC™ offers high quality services, and we can say that we have always been satisfied by their work.”
“The skillsets that PSC™ provides in regulatory support helped us overcome a large obstacle in particular. The regulatory support that we had from PSC™ was very independent and if we had an issue, PSC™ consultants were willing to work cross-functionally to meet our needs. No micromanaging required. Great communication. Minimal supervision. I don’t think we would have been as successful without them. The expertise and the connections we’ve created with PSC™ are beyond our expectations. I’ve never had that relationship with a company like I’ve had with PSC™. Just phenomenal! It made my life easier.”
“This is to certify that PSC Biotech® (PSC™) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”
CRM & Vault Modules Projects
Remediation Transition Validation & Compliance
Validation and compliance project for the transition of computerized systems from the previous system.