Abstract

Transform existing spreadsheets into FDA, GxP, or EU compliant laboratory records, complete with electronic records and signatures. SciCord Lite provides the framework to protect and secure Microsoft Excel spreadsheets to ensure compliance with 21 CFR Part 11 in GxP environments. Laboratory information management, Cloud delivery and Software as a Service (SaaS) deployment accelerate implementation, increase security, and eliminate internal maintenance and support effort.

Benefits of SciCord Lite

  • Instant Compliance – Automatic protection for existing or new spreadsheets.
  • Spreadsheet Migration – Maintain the process knowledge captured in your existing spreadsheets.
  • Intuitive Interface – Spreadsheet paradigm leverages scientist’s Excel skills.
  • Easy to Implement – Cloud-based environment immediately available.
  • Available Anywhere – Web interface connects from any Windows device.
  • Information Sharing – Customized views and read-only access supports searchability and access. 
  • Spreadsheet Validation Services – Identify and mitigate spreadsheet errors and risk delivering fully documented GxP compliant packages.

Key Features of SciCord Lite

  • Compliance
    • User Management – 21 CFR 11.10(d) – All spreadsheets require a valid User ID and password to access. – 21 CFR 11.10(g) – Each user can be identified as being able to read or edit spreadsheets.
    • Audit Trails – 21 CFR 11.10(e) – All spreadsheet changes – additions, edits, and deletions – are recorded.
    • Electronic Signatures – 21 CFR 11.10(j), 11.50, 11.100, and 11.200 – Users can sign each worksheet to prevent further changes.
  • Workflow Management
    • Implement compliant notebook lifecycle from creation through review and approval.
    • Metrics reports support compliance with requirements for timely notebook reviews
  • Review/Approval Process
    • Eliminate review of validated calculations and reports
    • Support for multi-person and multi-stage review
    • Enhanced communications between author and reviewer
  • Cloud Delivery
    • Your data available where you need it.
    • Scientists focus on science.
    • SaaS delivery model avoids costly internal IT and lowers the total cost of ownership.
    • Increased security for your data with multiple backups and archival.
  • Validation Services
    • Transform inefficient, localized, and unreliable spreadsheets into efficient, dependable, and scalable applications.