The process of proving that a computer system complies with a list of established system requirements is known as computer system validation, or CSV. As stated in the FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4, computer system validation to verify correctness, dependability, consistent intended performance, and the ability to recognize incorrect or altered records is a critical requirement of electronic record compliance.
For a range of FDA-regulated businesses, including those that make medicines and biologics, medical devices, perform clinical research, and run GLP laboratories, our computer system validation specialists have validated software.
Software Validation - Services for SAP, LIMS, Salesforce, Trackwise, and other business and laboratory data management systems' computer systems validation.
Web Based Applications - Services for specialized web, cloud, mobile application evaluation.
MS Excel Spreadsheets- Security of spreadsheets and compliance with 21 CFR 11.
MS Access Databases- Your internally developed databases have been rendered FDA compliant.
Veles DTX has given computer validation lectures and training sessions to organizations like FOI Services, ISPE, IVT, and PDA.
Computer System Validation - Computer validation training programmers that are scalable. Learn the fundamentals of computer system validation to guarantee compliance.
Spreadsheet Compliance and Validation - Online training courses that go over specific spreadsheet validation criteria.
Review of Computer System Validation Documentation and Techniques - Online courses that give a general overview of the validation procedure and recommended practices.
Veles DTX offers further advice and resources for computer system validation.
Validation Documents - A repository for data on functional specifications, validation strategies, and other validation documentation.
21 CFR 11.10(a) - Read about the FDA's standards for validating computer systems along with additional commentary from Veles DTX validation specialists.
FastVal - Utilize the validation management system from Ofni Systems to manage your validation process.
Part 11 and Validation Assessments- Veles DTX may evaluate the compliance of your organization's electronic records or develop audit checklists for you.
Software Testing - For companies subject to FDA regulation, specialist software testing services include stress testing, challenge testing, load testing, and others.
Data Migration - Following FDA recommendations, migrate data from legacy systems and guarantee reliable data transfer.
Computer validation goes beyond what is necessary for compliance. A firm has a rare chance with pharmaceutical computer system validation to review its IT infrastructure in order to improve quality and maximize efficiency.
Veles DTX makes sure that while scaling the project to your organizational validation requirements and budget, your validation project clearly outlines why your customers should share the high level of trust you hold in your business and your systems.