Computer System Validation

Automation of Laboratory Information systems validation using Performance Lab CSV solution to deliver compliance, reduced costs, and increased lab efficiency.

Performance LAB team is comprised of highly skilled lab information technologists, and regulatory experts who specialize in scientific computer system validation. Our consultants understand your business, your laboratory, your IT department, and your laboratory informatics systems.

Performance LAB robust and streamlined CSV solution covers a broad range of control systems, laboratory instrumentation setups, and lab data capture systems (e.g. LIMS, ELN, SDMS, CDS, etc), manufacturing and clinical database systems, as well as interfaces with other GxP systems.

CSV BUSINESS NEED FOR LABORATORY INFORMATION SYSTEMS

Laboratories are required to ensure on-demand availability of regulatory audit documentation to confirm the accuracy and integrity of processed data. They are subject to regulations such as GMP / CGMP, GLP, GCP, Annex 11, ISO 17025, ISO 15189; Title 21 CFR Parts 11, 58, 210, 211 and 820; ASTM Standard E2500, CLIA, etc.

By rolling out an automated Performance LAB CSV solution, you can:

  • Remove all the complexities across the pre and post approval stages, and reduce errors, costs and effort;
  • Simplify validation of larger applications such as enterprise document management systems (QMS) and lab information management systems;
  • Streamline and standardize activities, embed best practices, and drive dynamic data creation;
  • Perform sophisticated tests to unearth relevant information from software applications​;
  • Embrace an effective, risk-based approach to CSV, improve the up-time of software and instruments;
  • Shorten the validation cycle time by 60-90% and reduce the cost of your laboratory compliance​;
  • Provision easy access to validation information for your enterprise users and auditors;
  • Be always audit ready, fostering a culture of compliance across the organization.

OUR END-TO-END PERFORMANCE LAB CSV SOLUTION INCLUDES:

Validation planning

Performance Lab’s solution is not a generic CSV plan. We always produce a unique, personalized plan prepared by the laboratory and based on its IT landscape, data processing methods, and quality management techniques.

Validation lifecycle services

Our solution makes it possible to conduct CSV while processes are in motion, including: complete set of test reports and summary reports on the completed tests, the rights and access of users who contribute synthetic or specific primary data, quality management procedures, risk management procedures, a plan for restoring the system from backup, and the risk of data corruption or loss during recovery, and data migration plans. Our CSV services rely on the GAMP5 risk-based approach to compliant computer systems. Our solution allows QMS integration.

Validation testing and verification services

Our solution enables standard installation, integration and functional testing of the IT landscape as a whole and any of its systems and system components, as well as many specialized automated tests such as «monitoring of sums and balances» that, above all, allow the laboratory to monitor:

Data integrity services

Data integrity requirements in the medical field are strictly regulated by the laws of every large countries.  In particular, the FDA requires that all companies working with medical data ensure, that it is accurately and reliably processed, regardless of the format (paper or electronic), have unambiguous standards for storing and transforming medical data, and have a defined policy for managing the risks of data corruption and integrity problems.

Reporting & Release

The Validation Report (VR) summarizes the activities carried out during the project, describes many deviations, with justification, from the Validation Plan (VP), lists any limitations or restrictions on use, summarizes any incidents and details any outstanding and corrective actions.

SOLUTION MODULES:

This is a set of instruments that allows the laboratory and it’s consultants to significantly reduce validation cost and timing of the complex laboratory systems, including both laboratory and accounting systems, and any smart equipment.

Web-UI module:

This module is for testing the web user interface and for high-level work with web page components: buttons, tables, text fields etc.

Test data module:

This module is for working with test data and for generating test data (CSV, XLS, PDF formats). The module lets you read data in XLS and CSV formats, check whether the required data is present, create new documents, merge data from several sources into one document (from several spreadsheets into a single table), and generate tabular data. Working with data in PDF format involves reading files and checking whether the required data is present.

Reporting module:

This module is for test reports (data collection, generating HTML reports, and mailing reports). The module logs information about the actions taken by the test script to a JSON file. To generate a readable report, JSON data is converted to an HTML document. If there is a failure during a test run, a screenshot taken at the time of the test failure is attached to the report. The module also lets you to send the generated report by email via the SMTP protocol.

API module:

This module is for interacting with REST services and SOAP services

Data Integrity module:

CONCLUSION

Our solution will provide the laboratory with a set of test scenarios that is sufficient to track compliance with state and corporate data standards and make it possible to analyze policies related to the storage, transfer, transport, and migration of data to check for compliance with federal and corporate standards.

In order to ensure compliance with rapidly evolving regulations, you must chalk out a coherent strategy to identify, select, prioritize, plan, and implement robust automated tools for computer system validation.