Quality Control and Document Management for Life Sciences
The reach of today’s Pharmaceutical companies is becoming increasingly global, both in the demand for, and the sale of life-enhancing products. These organizations must sustain global manufacturing and distribution processes while addressing the potential operational risks, as well as overcoming the quality, safety and revenue pressures inherent in an already complex Life Sciences industry.
Two of the biggest operational risks for Life Sciences companies are compliance with 21 CFR Part 11 and Part 820 regulations. Failing to adhere to these regulations can hinder shareholder confidence, erode your bottom line, and cause irreparable damage to brand equity. As a result, many regulated companies seek to implement enterprise-wide compliance and quality management solutions that can quickly address customer and regulatory issues consistent with worldwide requirements, while simultaneously being leveraged to automate and enhance business processes.
Although many solutions claim 21 CFR Part 11 compliance, the cost of these systems is often prohibitive for all but the largest Life Sciences organizations. At the same time, many solutions are difficult to deploy and even harder to use, which further limits their ability to create compliant-environments quickly and effectively.
AKA provides a document management and quality control solution for Life Sciences companies, simplifying compliance with complete document lifecycle capabilities, including automated workflows, audit trails, and full versioning support. AKA helps companies address the regulatory requirements of FDA 21 CFR Part 820 and Part 11, as well as SOP management, clinical document management and a range of quality functions including CAPA, audits management, non-conformance and complaint management.
- Reduces time, effort, and costs associated with manual and paper-based processes.
- Integrated quality control and product safety document management solution for Batch Records, DMRs, CAPA, SOPs, Audits, Complaints, GMPs and more!
- Enables compliance with industry and government regulations, including US FDA 21 CFR Part 11.
- Increase control over operations, reduces the cost of compliance, and increases productivity with one integrated solution for all quality document management needs.