Companies that use spreadsheets for business process that involve GCP, GLP or GMP outcomes often look to tighten up good practice by focusing on the most immediate
problem(s) at hand. Typically that involves one or more of the following processes:
- Validate of the spreadsheet
- Verify that the use of the spreadsheet complies with Predicate rules and 21 CFR Part 11 requirements for security, audit trail and e-Signature sign offs
- Validate the application providing the controls
All three processes are important and play a critical role in the proper use of spreadsheets in labs, clinical trials, research or manufacturing and in meeting requirements of 21 CFR Part 11.
CIMCON believes that a sustainable compliance approach to Life Cycle Management of Spreadsheets should be comprised of repeatable business processes. Whether management is looking for help in the areas of inventory and risk assessment, validation/re-validation or deploying a 21 CFR Part 11 control environment there should be solutions in place that can meet these areas of need, today, tomorrow and into the future. Everyone understands the time, effort and challenges of spreadsheet validation but is enough attention devoted to inventory and risk assessment? Or to the final controlled environment that provides file level security and Audit Trail for change management? By using our Life Cycle Management toolbox all of these necessary processes can be addressed and managed in a way that complies with all GxP concerns while improving business intelligence, performance and a sustainable compliance approach.
CIMCON’s Life Cycle Management Approach is one that has been developed over many years, coupling our extensive domain understanding of spreadsheets and databases along with close working relationships with Life Science companies helping them to address information, validation or control gaps in their unique processes. Besides the knowledge base which has grown from these relationships there are three independent but closely aligned software applications which CIMCON has developed and that can be applied to these ongoing business and regulatory concerns.
- XLRisk – Spreadsheet Inventory and Risk Assessment
- XLValidator – Streamline Validation Process
- eInfotree Excel Module – Control Spreadsheets in a 21 CFR Part 11 Environment
Throughout the Life Science industry as in other business verticals there is pressure to cut costs, increase production while keeping quality and safety high. The use of smart software toolsets can aid in your 21 CFR Part 11 compliance initiatives, add quality enhancements to a number of business processes and provide peace of mind to management that all necessary aspects of spreadsheet/database management are being met. Furthermore once this sound approach to a spreadsheet management strategy is understood and implemented the outcome at any part of the process whether it is information gathering, validation or production use is enhanced, moves along faster and the output is far more secure. A Life Cycle Management approach leads to repeatable sustainable processes that aids business requirements and all quality and compliance activities.