Compliance: Demanding and Ever-Evolving Regulations
Regulatory compliance is a major concern for the pharmaceutical and biotechnology industries. Stringent standards are imposed on the Life Sciences sector to ensure patient safety, product quality, and data reliability. Compliance for these companies becomes even more challenging as regulations constantly evolve, especially with the implementation of international certification standards.
Companies must provide documented evidence for the maintenance and market release of healthcare products. Using spreadsheet software like Excel™ and paper-based methods does not align with regulatory requirements for data safety, integrity, and traceability. Therefore, companies are compelled to digitize their procedures to meet compliance standards and avoid legal and financial consequences
Businesses’ needs
- Digitize Business Processes: To eliminate manual procedures (such as Excel™ and paper), the GxpManager No Code Low Code platform is ideal for quickly digitizing forms and more complex processes.
- Compliant Business Applications: Businesses require compliant applications to facilitate the creation of documented evidence. GxpManager applications inherently comply with 21 CFR Part 11 and Annex 11 of Good Manufacturing Practices (GMP), offering features like electronic signatures, audit trails, and access management.
- Simplified Application Validation/Qualification Processes: The GxpManager platform comes pre-qualified (Installation Qualification – IQ and Operational Qualification – OQ), reducing the validation cost.
- Agile Solutions for Regulatory Adaptability: In this ever-evolving sector, businesses need agile solutions to adapt to regulatory changes. Our applications are developed using No Code Low Code, providing significant flexibility.
