Manufacturing firms seeking FDA and food regulator has come under immense pressure to adapt LIMS as it is believed having LIMS make securing FDA apporval easy. However it is important to note, that (Federal Drug Controller/agency) FDA and GMP (Good Manufacturing Practices) guidelines have very specific requirements that are essential in LIMS in these firms. SmartTesting LIMS team have been working to standup to benchmark set by GMP and CFR 11 guidelines governing IT system of user operational environment.
SmartTesting is available for deployment on customer environment not restricting its offer to its own cloud which is the case for its proposition to commercial laboratories. Smart Features that makes SCC LIMS stand apart are as below
– Scheduling and logging of Various routing Activities such as Cleanliness audit, temperature monitoring.
– Optional Integration with the hardware and other IT systems of the customer IT landscape
SmartTesting Features Supporting Compliance with 21 CFR Part 11
FDA CFR11 expect a lab to have complete control over data and trace its origin or source i.e. User who did it and when.
- Sample Life Events tracking, track major events in the sample Life cycle, major amendment in the sample details, passing different gateways in the work flow, such as result approval, authorisation, Report publishing, revision of report etc.
- Audit trails of result data automatically capture details of User ID, Date and Time and reason wherever applicable for change, original value and new value.
- Versioning of replaced test results and reports in case of revision of test report, QA test of sample within the sample life period
- Tracking outsourcing of samples and projecting MIS reports highlighting outsourcing and reason of outsourcing.
- All users are uniquely represented by their user login and password, their signatures are linked with the user login details.
- Only authorised and trained users are allowed to change what is allowed to them
- Meter/Instruments that has expired calibration date are not allowed to be linked with the test results
QMS:Quality Management System
- All standard operating procedures and templates could be uploaded on to the LIMS for quick reference
- Changes in different version of documents are logged and also linked with training modules
- Question bank relating to the document is updated with each change of the document
- Automatic reminder of scheduled changes to the document
- Linking departments/functions with the documents to enable automatic selection of staff required retraining
- Training Scheduling, marking user with the training score
- Corrective and Preventive Action: An integrated modules with core LIMS, any out of specification result is logged as an incident to initiate the CAPA process with its own steps
- Analysing and marking cost of incident
- Identifying causes of the incident
- Analysing impact of the incident (Financial, operational or reputational)
- Analysing and identifying root cause using graphical fish-bone analysis
- logging potential solutions, cost benefit analysis and initiation of corrective and identified preventive action plan
- followup on preventive action plan
If you have any query or clarification with respect to GMP or FDA CFR 11 compliance, do drop us your query Contact SCC IT Solutions.
Other related links
1. LIMS software for material testing Labs
