A Lab environment usually consists of numerous lab/instrument software applications that often have the following characteristics:
- There is no security or login to the software application.
- There is no security of the data files generated by the lab instrument.
- The data files are not backed up, or if they are, not backed up in real-time causing potential for alteration or change.
- End-Users have full Administrator access to the Windows folder allowing data to be copied, renamed, and deleted.
Without a centralized control and reporting system, it is challenging to overcome these problems and secure the instruments and the software and make them Part 11 compliant. This is due to several reasons:
- A 21 CFR Part 11 compliant version of the software may not be available as that is not an important market for the instrument supplier.
- Even if an upgrade is available, it may be time consuming and costly. Plus, there are costs of re-validating the new version.
- Several other controls still need to be established outside a specific system e.g. access to the desktop, data files, and backups.
Not surprisingly, lab systems/applications are a frequent source of FDA warning letters.
CIMCON’s LabMonitor provides a Centralized Lab Management System that overcomes all of these issues.
Security: LabMonitor secures one or multiple lab applications so that only authorized persons can access the application or make changes.
Data Files: LabMonitor continuously monitors the data files, and backs them up immediately when they are created. Users do not have access to access or edit the data files.
Audit Trail: An audit trail of all user actions, data changes and activity is maintained.
Backups: Backup your files centrally to a secure repository and apply record retention rules.
Electronic Signatures: Signoff on lab reports and other data electronically.
Workflow Designer: Make reviews and approvals quick and easy using a built-in workflow designer.
Part 11 Compliance: Bring one or multiple lab applications into compliance with this compliance wrapper.
Centralized System: LabMonitor allows you to manage any no. of applications at once with a centralized user interface.
Complete Lab System: Manage your lab instructions and procedures, instrument manuals and other forms using LabMonitor.
Spreadsheet Life Cycle Management for Part 11 Compliance
The United States Food and Drug Administration’s (FDA) modern regulatory function started with the 1906 Pure Food and Drugs Act and continues through 21 CFR Part 11, which details the criteria for reliable electronic records and signatures as used in pharmaceutical and medical device manufacturers, bio tech companies, research labs and clinical trials. Commonly referred to as Part 11, the regulation calls for controls such as system validations, audits, audit trails, documentation and electronic signatures to make certain predicate rules created for paper documentation can be applied to electronic documents as a means of ensuring the accuracy, reliability, integrity, availability, and authenticity of required records.
This white paper explains how these predicate rules apply to electronic records and how a sustainable compliance approach to the life cycle management of spreadsheets, comprised of repeatable business processes, can help in the areas of inventory and risk assessment, validation or re-validation or deploying a 21 CFR Part 11 control environment.