Services Banner Images

Computer System Validation

If you are a company that relies on electronic records for certain parts of your workflow, your systems may be subject to the requirements and limitations of US FDA 21 CFR Part 11, Electronic Records; Electronic Signatures, or other industry guidelines including GAMP5, ICH, EMEA regulations and 21 CFR regulations. For companies outside the pharmaceutical and biotech area, there could also be increasing ISO and clinical standards requirements requiring computer system validation to verify that electronic records are controlled and unadulterated.

Computer system validation (CSV) is the process of establishing documented evidence that a computerized system will consistently perform as intended in its operational environment. CSV is of particular importance to industries requiring high-integrity systems that maintain compliant with current regulations (EU, FDA) under all circumstances.

Our CSV services can enable you meet global regulatory requirements and help you reduce your compliance risk.

Benefits of Our Computer System Validation Services

Compliance Images

Our Experience – Our Principal consultants have more than 15 years of lifesciences and Pharmaceutical experience. We have Subject matter expertise in manufacturing, Research, Lab equipment’s, chemical & biotech processes, Software systems and Interfaces.

Cost – We understand the cost of validation and its impacts on the healthcare cost. We provide utmost commonsense in our validation approach and employ strategies that effectively leverage processes within the clients, thereby reducing the cost. Also, we are one of the top service providers in the industry providing Offshore Support for Computer System Validation which has helped many clients reduce cost.

Reduced Validation Time and Control Costs – Employ Outsourcing Model

Quality and Time – We provide utmost importance to Quality in the deliverables and deliver within the specified timeline. We employ factory testing approach for Validation, thereby deploying validation resources on the ramp up basis.

United Techno’s Computer System Validation Services include but are not limited to:

  • Manufacturing Execution Systems (MES)
  • Laboratory Instrumentation and Software
  • Laboratory Information Management System (LIMS)
  • Electronic Document Management Systems (EDMS) – Documentum, Filenet
  • Adverse Events Reporting Systems (AERS)
  • Enterprise Resource Planning (ERP)

      SAP – Experts in Validation of Batch Management, ePedigree, Quality Assurance/Control, Supply Chain and     Pharma Manufacturing (MES)
  • Compliant Handling Systems
  • Corrective and Preventive Action Systems (CAPA)

Computer System Validation Deliverables

  • Validation plan
  • System Impact Assessment
  • Requirements specifications (URS, FRS, FS/TS)
  • System configuration specifications
  • Test plan
  • Installation Qualification (IQ) testing and Reports
  • Operation Qualification (OQ) testing and Reports
  • Performance Qualification (PQ) testing and Reports
  • Assessment for compliance with regulations pertaining to electronic records and signatures (e.g., 21 CFR Part 11)
  • Traceability matrix
  • Quality assurance review
  • Validation summary report
  • Draft/ Review of Standard Operating Procedures (SOPs)
  • GMP, GDP Training

Risk Assessment Approach - a practical approach to compliance

  • Procedural controls identification
  • Impacts to Compliance, consumer and business
  • Employee training and qualifications
  • System validation state
  • Change management/change control
  • Document control
  • Part 11 compliance
  • Qualifications and CSV procedures