Computer Systems Validation

Consulting and Outsourcing

When you work with PSC Biotech, you can expect a seamless, FDA and EMA compliant, customised 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 a key element of a company’s success. Our specific areas of expertise within computer systems validation are included below. Developing and bringing to market life-changing drugs and devices: 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 specialised in computer systems validation consulting services, PSC Biotech works to ensure life sciences companies’ processes are functional and in full compliance with FDA and EMA guidelines. With over two decades of consulting experience in the life science industry, we fully understand that computer systems are a key element of a company’s success, so we guarantee these systems are running efficiently and accurately when you work with PSC Biotech.

Our CSV Services

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 audit ready 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.

Validation

The implementation of an Enterprise Resource Planning system presents unique challenges as well as opportunities for companies of all sizes.  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 to the creation of accurate reporting.  ERP systems can represent a substantial financial investment, and with proper planning and implementation of this foundation will provide seamless processes and insight to support strategic opportunities.

Laboratory Equipment Software Validation

One-of-a-Kind Expertise to Address an Ever-Changing Industry

PSC Biotech™ has vast experience in the validation of laboratory equipment software in both GMP and GLP environments, recognizing the key part these instruments play in the overall quality and integrity of life sciences data.  PSC Biotech™ has excellent background 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, PSC Biotech™’s robust, risk-based approach ensures high quality, cost effective solutions. 

Clinical Data Systems

A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS.  Clinical Data Management Systems are important to produce and maintain quality data generated during the clinical trial.  Data in a CDMS generally follows the following sequence:

  • Generation of source data, this includes items such as 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 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), 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 compiled. Significant results may cause further data reporting activities such as tables, listing 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 it is likely they will report intermediate discrepancies and listings to identify problems before completion of the entire clinical study.

Clinical Data Management System have extremely high compliance standards to adhere to because of the critical role they play in the evaluation of the potential therapies safety and efficacy.  Data integrity and Data quality is of the highest importance in performing a clinical study. 

When PSC 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 defines data integrity and data quality for both paper and electronic clinical records by the acronym “ALCOA”.  ALCOA means:

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 important considerations:

  1. That the data is readily available, transmissible;
  2. Storable and data are complete and unbiased;
  3. Data are in a format that is internally consistent and compliant with or readily transformable to accepted standards.

How can PSC help validate your Clinical Data Management System?  PSC can perform validation of clinical data management programs and procedures required to document that clinical data management standards are met. PSC has experience with the following systems:

  1. eClinical Solutions™
  2. Egnyte™
  3. Clindex™ Clinical Data Management System
  4. Clinical Conductor CTMS™
  5. BioClinica CTMS™
  6. BSI CTMS™
  7. RealTime CTMS™
  8. Ennov CTMS™
  9. DatStat CTMS™
  10. CoreValue CTMS™
  11. MasterControl Clinical Excellence™
  12. LifeSphere CTMS™
  13. Clinical Studio CTMS™
  14. Castor EDC™
  15. Medrio™
  16. ClinCapture™
  17. Medidata CTMS™
  18. Veeva™
  19. Research Manager™
  20. OpenClinica™
  21. Ripple™
  22. Vision™

Data Integrity

Our CFR Part 11 compliance reviews are based on a justified and documented risk assessment, and a determination of the potential of the system to affect product quality, patient safety, and record integrity.  Computer systems used to create, modify, and maintain electronic records and to 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 consultants will work with you to review your existing validation procedures and documentation in order to identify any gaps in validation, define any remediation activities, and develop 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 play an important role in ensuring the manufacture of quality biotech, pharmaceutical and medical device products and will also provide comfortable conditions for operators or any personnel that are in the area supplied with air from HVAC system.
 For the life sciences companies, the design of the HVAC systems has a direct impact on the key 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.

HVAC COMMISSIONING

Commissioning activities include the testing, adjustment and balancing (TAB) of the entire HVAC system, to ensure that it meets all the requirements, as specified in the User Requirement Specification (URS), and the specifications 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 documented should include items such as the design and measurement figures for airflows, liquid flows, system pressures and room classifications.  The commissioning plan should start at the early stages of a project so that it can be integrated with system qualification procedures.

PSC 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)

HVAC QUALIFICATION

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 means of a Risk Analysis (RA) for all HVAC installation components, subsystems and controls.

PSC 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 airflow 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

Validation is requirement of Good Manufacturing Practices (GMP) mandated by US FDA, EMA, CFDA, KFDA, TGA and other global regulators. HVAC Performance Qualification (PQ) focus is 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 protection of 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 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 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.  Our team can guide you to a successful validation effort, ensuring a positive outcome on a preapproval inspection (PAI).

Facility Management

PSC has experience integrating your existing Building Management System (BMS) into your existing Electronic Quality Management System (eQMS) or Enterprise Resource Planning (ERP) system. Our computer system validation experts have experience in integrating a wide range of platforms in order to make your processes and systems seamlessly work together to gain maximum efficiencies. 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.

Adverse Events Systems

Adverse event planning is vital to detecting, processing and reporting in a complete and timely manner.  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 larger Enterprise Resource Planning System, PSC Biotech Consultants will help you avoid the pitfalls created by company culture issues or failures in requirements planning and/or the forecasting of adequate resource needs for implementation.  Whether you’re using Dynamic Lot Sizing, Least Unit Cost or other model, PSC Biotech Consultants will assist in problem areas such as 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 Consults 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 impact on development and delivery cycles.

Calibration Management Software Implementation & Validation

When performing thousands of calibrations each year, the management of your calibration processes is vital to ensuring manufacturing continuity, efficiency, and compliance.  The use of 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 more accurate analysis of historical trends and optimize calibration intervals.

PSC Consultants will work with you to review your current procedures and documentation, identify any gaps, manage the implementation and validation of calibration management software, 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 is working properly, and the validation of instrument measurements are maintained and documented.

Plant Maintenance Asset Management System Implementation & Validation

Our subject matter experts stay at the forefront of industry development and will ensure 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 a QMS 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.

Thermal Mapping

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 to us as your service provider, we make certain that all components of the project are in sync- from the protocol writing, to validation equipment used and calibrated, to final report generation and review.

 

What Our Clients are Saying

“The completion of this project was vital to maintaining the validation status of hundreds of systems and applications used in a variety of activities in Research & Development, Chemistry, Marketing, Supply Chain, and so on.  The PSC Technical Staff was able to develop validation documentation (Compliance Assessments, Plan, Protocols, Scripts) in conjunction with the business groups, was able to support execution of System and User Acceptance testing, and was able to draft and submit Test Reports, Traceability Matrices, and Summary Reports for each of the applicable Non-Product Software systems and applications.”

“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.”

“Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and running requests back and forth from the conference room. AuditUtopia™ has been tested during my simulated FDA mock inspections and it serves to overall stream-line the inspection process. As a former FDA investigator, I fully endorse AuditUtopia™ and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line.”

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