Services

Our quality, compliance and program/project management professionals at DBA Systems takes a proven, hands-on approach to addressing our clients’ specific QA and compliance situations to ensure their quality and regulatory operations are in compliance with current industry standards and ICH & Local regulations.

While various consulting companies have created their own methodologies for systems validation, our experience shows the following framework to be the comprehensive and applies to both -off-the-shelf software or home grown. This framework ensures that the software being deployed is most likely to be compliant with ICH Regulations requirements and will continue to sustain the compliance over time. Key elements of that framework include:

Compliance with core 21CFR Part 11 requirements: This element ensures that the software is compliant with key requirements of the regulation, including

• Any change to any record is captured in the audit trail and these entries are time stamped with additional information including operator name and why the record was changed
• System provides adequate security to prevent unauthorized modification by ensuring role-based access and preventing users from directly updating the database
• Software employs electronic signatures for any transaction into the system