The life-sciences industry is one of the most heavily regulated industries. Companies in this industry face a lot of risks and challenges to meet compliance related requirements from various bodies. Providers in this industry need to deal with massive amounts of digital data including clinical, electronic health records, social, genomics etc. Vast amounts of data and information often housed within legacy systems needs to be managed and shared with the right stakeholders to be able to make decisions.
Increased competition, greater customer expectations and rising costs are some key challenges being faced by companies. Companies are increasingly focusing on cost reduction especially in business processes not directly related to R&D such as procurement, finance and operations.
Automation of critical processes for compliance management and electronic records is being adopted by several companies in this industry – from formal SOP review and approval, informal research collaborations and compliance with quality and safety regulations. CIO’s are enabling a more collaborative organization allowing for secure and easy sharing of key information amongst team members, handling vast amounts of data and documents to best support decision making.
Critical Success Factors
The critical success factors for companies in this industry include:
- Moving over from error prone, paper based systems.
- Automating manual review and approval methods including automating the entire process of creation, review and approval quality documents.
- Managing 21 CFR Part 11 compliance, deviations, audits and other national and international regulations etc. in a single integrated solution.
- Generating on-demand reports that provide visual indicators of the status of quality tasks, processes and documents.
Key Business solutions
Given the high standards in quality of products, processes and functions, lack of visibility and deviations in quality systems can be potentially very dangerous for a lifesciences organization. This solution helps achieve the highest quality while maintaining compliance across all key processes and systems. Electronic forms and workflows automate the entire process of creation, review and approval of quality documents. On demand reports provide detailed visual indicators on the status of all quality tasks, processes and documents. This allows audit trails, easy retrieval of information. Electronic signatures ensure rapid availability and traceability of all information
Enterprises in the lifesciences industry invest immensely in design, construction, operations and maintenance of their manufacturing infrastructure – not just the physical plant but also the manufacturing equipment. There is a tremendous influx of information of these assets including work orders, maintenance records, engineering drawings and specifications, incident reports and regulatory reporting. This solution links all information irrespective of where it resides in the organization back to the asset and thereby improves consistency and compliance.
This solution builds on top of your existing Microsoft Sharepoint base making content accessible to your employees throughout its lifecycle to comply with regulations, improve system performance, reduce costs and increase productivity.