Computers automate many tasks throughout the laboratory and nearly all modern instruments require computerized software. The importance of instrument workstations cannot be overstated based on their use in device control, data acquisition, processing and reporting. But despite their ubiquity and importance, these systems are often overlooked by GxP compliance programs and can result in FDA 483 findings.
Workstation software validation ensures that that OEM software is up to the task of complying with quality and regulatory requirements such as 21 CFR Part 11. But important doesn’t necessarily mean expensive. We offer a focused validation service designed specifically to this type of off-the-shelf software that simplifies the scope of testing while ensuring GMP compliance. Our validation model is designed to address the factors critical to your lab such as:
Instrument’s criticality in product testing
Touch-points to a LIMS, CDS or network storage
Data security requirements
System functionality boundaries
Procedural controls for operation and administration
IT infrastructure policies
Enterprise Software Validation for the Laboratory
Data management software is almost as critical to the laboratory as the instruments themselves. Enterprise systems significantly improve laboratory performance by automating a wide variety of processes and data transactions. But the real value of these systems lies in their endless configurability which can be designed to suit each company’s specific needs. The challenge for the GMP laboratory is validating what is essentially a unique Laboratory Information Management System (LIMS) or Chromatography Data System (CDS) configuration. System controls are also be a major challenge under the best of circumstances, particularly for life science companies which must comply with FDA and international regulatory requirements.
We have the perfect framework for any laboratory software validation project. Our experienced validation consultants utilize our unique enterprise software validation model to work collaboratively with your team. This methodology maps the software processes and develops targeted requirements for security, data integrity, electronic signatures and networking that address GMP and 21 CFR Part 11 demands. We then use a proven risk management process to focus the scope of validation so that testing is focused on the software functions most critical to your business. Not only does this result in a high level of FDA compliance (in fact, the FDA prefers risk based methods of validation) but it can also provide fresh insight into your laboratory operations.