Approach
Compliance with GxP regulated standards is a very specialized activity. Suggesting that one system can supply all the necessary complexity and detailed knowledge input is optimistic in the extreme. It is not only a matter of being able to comply with key global or regional regulations (e.g. FDA or EMEA) but there is also a need to comply with local standards (e.g. effluent disposal protocols). Complicating this activity with content related to financial, employment or office systems leads to compromises in performance.
At SOLABS we believe that any system is only as good as its implementation. Our service-based approach provides not only a dedicated platform that is capable of tracking activities along the entire drug development cycle but it also benefits from the knowledge and expertise of our staff who implement, train and maintain the systems. As an investment you can directly measure its contribution to your business by its projected and measurable ROI. You can have a higher level of confidence, therefore, in achieving the benefits that you have defined.
SOLABS:
- Has a track record, covering both major and medium sized life sciences companies;
- Provides "best of breed" expertise for integrating both technologies and services;
- Proposes the highest ROI yield model in the industry;
- Presents no "cost of ownership" issues;
- Presents no user licenses, concurrent licenses, or maintenance costs;
- Promises no headaches with regards to any change to 21CFR Part 11 requirements;
- Offers guaranteed validatable technologies;
- Guarantees validation at a fraction of the standard cost and time to production;
- Offers a ready-to-use technology i.e., no customization needed;
- Offers 100% GxP-focused functionalities;
- Has an implementation expertise;
- Has GxP business process fitting expertise;
- Is auditable as a software provider.