If customization of an existing application or development of a new solution is desired, we follow a defined Software Life-cycle methodology, which has been structured based on the industry guideline GAMP5. Our life-cycle methodology will meet the requirements of world regulatory bodies.
PSC Biotech combines the insight and expertise in compliance with the proven programming techniques to develop software applications that are utilized in many facets of the life science industry. Our core strengths understanding the compliance elements of software development are reflected in our success in creating custom software implemented by major pharmaceutical companies such as Novartis and Bayer.
Leveraging our knowledge and expertise, we can develop specific software to help you:
- Meet regulatory compliance.
- Guarantee the authenticity, integrity and confidentiality of electronic records via establishment of measures and controls.
- Integrate manufacturing systems thus augmenting efficiency.
- Present and preserve an audit trail to enhance control, transparency and accountability.
- Make information and reporting readily available.
- Enforce business rules and processes.
- Facilitate business management and automation.
- Interfacing with other business systems.
If you would like more information, get in contact with us directly here.