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 Since the introduction of 21 CFR Part 11, which lists requirements for Electronic Records and Electronic Signatures, the regulated industries have been working very hard to interpret and implement the rule. The same process has occurred within the vendor world, with varying results. Most vendors have done a responsible job in introducing Part 11 controls into their products. Although the rule has been in effect since 1997, it is only recently that major applications are surfacing with built-in Part 11 controls. The quality of those controls is also affected by the vendors' interpretation of the rule, as well as the existing technology their products are based on.
As LabWare LIMS is a product designed to meet all the requirements within the Pharmaceutical and other regulated industries, we began our journey for Part 11 support as soon as the rule was issued. LabWare LIMS provided support for Part 11 requirements before the year 2000.
A key element to LabWare LIMS' support for Part 11 is that all Electronic Records (ER) are authenticated prior to being permanently written to the database. This process is done either by prompting the user for their password, or by using technologies such as Biometrics and Tokens. LabWare LIMS has been extensively tested and reviewed to ensure that all ER within the system have been properly addressed and meet Part 11's technical requirements.
LabWare LIMS also includes full support for Electronic Signatures (ES). This allows our customers to avoid operating in a Hybrid environment (Handwritten Signatures against Electronic Records), providing actual benefits above and beyond compliance. Many LabWare LIMS customers are operating purely paperless environments within the laboratory arena, without the need to print and sign pieces of paper.
Evidence of LabWare's success in interpreting the rule and building the necessary controls into LabWare LIMS is the fact that it was the first LIMS product to go live in the Pharmaceutical Industry, with full Part 11 compliance.
LabWare LIMS includes several unique features for Part 11 compliance, such as:
- The ability to configure any action upon an ER/ES check failure, including setting off alarms and sending messages to the company's security staff
- Encryption, which prevents unauthorized modifications to audit trail and other data
- Ability to include a controlled digital representation of a signature on reports
- Full support for Token technologies, which is emerging as an excellent and low cost solution for authentication
- Authentication of all data, not just dynamic data (like results) and static data (like analyses) but also all configuration elements such as Event Triggers
We are very proud of the solutions we offer for Part 11 compliance, but we accept that the rule is constantly being discussed and reinterpreted, and that better technologies may appear on the horizon. To ensure that we are always supplying the best possible solution to Part 11 compliance, we participate in a wide variety of discussions and conferences, frequently with direct contact with decision makers with the regulatory bodies. This has placed LabWare at the forefront of this issue, and we are recognized as a leader on how Part 11 affects the workflow within the regulated LIMS world.
A detailed White Paper on how LabWare LIMS addresses all aspects of Part 11 is available upon request.
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