Assessment of your processes
Success in implementing a system depends heavily on the competency of all involved people and the way of collaboration.
- Selecting the right partners
- Assessment of procedures and practice
- The recognition of the potential for improvement
- Clearly defined and communicated accountablity and responsibilities
- The optimal use of potential and capacity of procedures and human resources
make you successful.
System audits and software certification may show, that your software, your systems have been developed and implemented according to regulations and standards (i.e., IEEE 1012, or 21CFR820).
System audits and software certifications
demontrate that a software or a system were developed following given norms (e.g., general standards such as IEEE 1012 or 21CFR820).
Benefit from our huge experience
- Run GxP audits
- Assess your suppliers using the appropriate technique
- Assess projects, systems and organization through internal and mock audits.
- Exercise reality performing Mock-Audits against GAMP 5
- Assess maturity of testing and development according to various maturity models, i.e., TPI, CMMI
- certify your software against standards, i.e. GAMP, IEEE.
The resulting measures might include
Risiko-Management
Compliance Management (pragmatically achieving the goals)
Computerized Systems Validation
Testing