The FDA and SEC hold stringent, yet fluctuating, standards for software validation and regulatory compliance. The changing scope of these regulations makes IT compliance very time-consuming and costly for firms to handle on their own. These agencies, depending on the industry, have extensive regulations in terms of the accuracy and reliability of electronic record-keeping systems and electronic signatures. Validating systems, especially in lab environments, has been our specialty throughout our years of working with firms in the Life Sciences industry. Our compliance expertise is available for check-ups, consultations and short-term and long-term projects, and our expertise is transferrable to other industries that require software validation. We can help manage your firm's risk, untangle compliance complexity and control costs with our value-driven services that include:

 

System Assessment

•    Assessment of current compliance practices

•    Assessment of existing software validation

•    Consulting about compliance best practices

 

Regulatory Compliance Support

•    21 CFR Part 11 Assessment

•    Software validation plan

•    On-site training of auditing and IT security best practices

 

Validation Project Management

•    Experienced project managers to speed up execution   

•    Versatile on-site support

•    Secure remote support as requested