Computer System Validation (CSV)

Computerized system validation (CSV) is the documented process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.
Simpruv's simple and appropriate manner of establishing the required documented evidence for the proof of the same, holds a great value and assures that a computerized system will consistently perform as intended in its operational environment. The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules.
CSV is of particular importance to industries requiring high-integrity systems that maintain compliant with current regulations designed by different national and international regulatory authorities like USFDA, EMEA, EU GMP, ANVISA Brazil, Health Canada, WHO and ICH Guidelines etc.. under all circumstances.
To meet the ever increasing challenges of regulatory compliance and laboratory efficiency
  • Pharmaceutical companies are continuously seeking for newer and latest analytical instrumentation and CDS and networking software's like Waters Empower, Thermo Chromeleon, Agilent Open lab and Schimadzu Lab Solutions etc..
  • Clinical and pharmacokinetic study labs those perform BA/BE studies with high end LC-MS instruments need more data security and safety.
  • Also these labs calculate and compile data using computer systems mandatorily.
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.
Not only pharmaceutical companies, for companies outside the pharmaceutical and biotech area, there could also be increasing ISO and clinical standards requirements requiring mandatory computer system validation to verify that electronic records are controlled and unadulterated. Simpruv offers CSV services that enable you to meet global regulatory requirements and also help you reduce your potential compliance risk.
Learning Management Systems help in overcoming such problems and give peace of mind to the managers and organizations which give complete security and tracking all the activities and trainings that act as important evidence. Apart from maintaining compliance, a Learning Management System (LMS) based solution can prove to be extremely efficient to deal with the training requirements of the industry.

While there are several Learning Management Systems available in the market, only a few can help pharmaceutical companies to comply with Title 21 CFR Part 11and IP/OQ/PQ protocols. Organizations must ensure that they partner with those LMS vendors which have significant experience in implementing LMS for Pharmaceutical companies. The vendor and the system must have already undergone several audits on Title 21 CFR Part 11and IP/OQ/PQ protocols.

Simpruv LMS is based on platforms that has successfully implemented its LMS for several pharmaceutical companies in India and the systems maintain these compliances, which help in overcoming the risk of FDA imposing serious penalties on the organizations.
What's the Benefit of Simpruv’s Computer System Validation Services:
Our Principal consultants and Subject matter experts have more than 12 years of Pharmaceutical, Clinical, BA BE experience. Simpruv operates with a trained and qualified personnel under the guidance of the Subject matter experts with sound knowledge and awareness of the activity, intricacies in different regulated environments... Manufacturing, Research, Lab equipment’s, Chemical & Biotech processes, Software Systems and Interfaces.
For a more detailed understanding, refer the next pages
Current pain areas of Organizations:
  • cost of validation
  • Risk of documentation
  • lack of skilled persons to identify the exact requirements and
  • Quality of validation
  • Time for execution
  • its impact on audits.
1 ). Cost of Validation:
We provide a toughly debated, designed and practical and approach 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. Cost involves the risk of failure in audits as wells as the health care cost. This ensure that the cost of activity is well addressed.
II). Risk of documentation and requirements identification
Our protocols are designed in very simple yet practical approach and fulfilling the required documentation and create confidence by way of
Current pain areas of Organizations:
  • Initial discussion with the customer team
  • Creating awareness by way of a presentation and discussion session for
  • requirements identification and
  • validation planning.
  • identifying exact timelines for the completion activity, documentation and verification and
  • a debate on protocol with the technical team to plan the activity
where the customer is ensured complete peace of mind and confidence about the implementation of the validation. This also significantly reduces the Validation Time and Controls Costs.
III) . Quality of validation and Time for execution.
Another factor to think upon is the quality of validation and time for execution.. The above stated approach delivers Quality in all the deliverables and also deliver within the specified timeline.
All these approaches are tested at root and then the resources are allocated which further reduces time of execution and there by controlling costs as well as activity.
Also, increased confidence on the data and the process.
Current pain areas of Organizations:
  • Initial discussion with the customer team
  • Creating awareness by way of a presentation and discussion session for
  • requirements identification and
  • validation planning.
  • identifying exact timelines for the completion activity, documentation and verification and
  • a debate on protocol with the technical team to plan the activity
where the customer is ensured complete peace of mind and confidence about the implementation of the validation. This also significantly reduces the Validation Time and Controls Costs.
System Requirements
Documented system requirements are required for CSV as they clearly stipulate the intended use of a computer system application. System requirements are gathered and documented in the system definition phase. System definition artifacts that reflect these requirements can include, but are not limited to, the following:
  • User Requirements Specification: Details each feature of the system.
  • Hardware Requirements Specification: Minimum hardware required to support the system.
Typically CSV is becoming mandatory with those systems that are dedicated or operated with..
  • Electronic Document Management Systems like– Documentum, FileNet
  • Training and Laboratory Management Software (TMS/LMS)
  • Laboratory Instrumentation and Software (LIS)
  • Manufacturing Execution Systems (MES)
  • Laboratory Information Management System (LIMS)
  • Adverse Events Reporting Systems (AERS)
  • SAP ERP Systems that are mostly used in SCM(Supply Chain Management), Batch record generation, Quality
  • control and assurance master file holding systems, Leave management, Safety and Health record management etc.
  • Compliant Handling Systems
  • Corrective and Preventive Action Systems (CAPA)
The above is a comprehensive but not a detailed list and CSV is mandatorily asked by many areas where the regulators feel concern over security regarding data generation and modification.
Computer System Validation Deliverables
  • Validation plan
  • System Impact Assessment
  • Requirements specifications
  • System configuration specifications
  • Test plan
  • Testing and Reports for
  • Installation Qualification (IQ)
  • Operation Qualification (OQ)
  • Performance Qualification (PQ)
  • 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
  • Review of Standard Operating Procedures (SOPs) and Training
The list is a comprehensive and may be amended and Annexure & documents can add up based on the category of the organization and based on the validation planner.
All these fulfill the required typical model of GAMP 5.

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