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:

[accordions_pplugins id='626']

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.