The Extra-Secure software license contains a higher degree of control over authorised access. It is suitable for incorporation into a validated system conforming to 21CFR Part 11.

The 'Extra Secure' option is 21CFR Part11 compliant when used in conjunction with a full company wide 21CFR part 11 system.

For a demo of this software see www.icespy.com\help\System5ExtraSecureFeatures.htm  

Also available is our validation package

Minimum PC Requirements

What is 21CFR Part 11?

It has long been the case that important paper-based records have required handwritten signatures to guarantee authenticity. With the advent of computer-generated (electronic) records, and more importantly the storage and delivery of those records by electronic means, it has become important in many circumstances to guarantee that data has not been tampered with between its generation and its final use. Part11 of the FDA requirement 21CFR addresses this issue.

Although the regulations originate from the USA they are being increasingly adopted throughout the world in the pharmaceutical sector.

The FDA (Food and Drug Administration) in the USA issued regulations Title 21CFR (Code of Federal Regulations) Part 11 that provide criteria for acceptance by FDA or an approved regulatory body, for the acceptance of electronic records, electronic signatures and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures exected on paper.  These regulations, which apply to all FDA program areas are intended to permit the widest possible use of electronic technology compatible with the FDA’s responsibility to promote and protect public health.  Part 11 applies to any recorded governed by an existing FDA predicate rule that is created, modified, maintained, archived, retrieved or transmitted using computers and/or saved on durable storage media.  In other words any record ( from a data logger for instance) that is at some stage stored on a PC or where a PC is used to retrieve the data, 21CFR Part 11 can be applied.

How IceSpy can help compliance

IceSpy System5 software (Extra Secure version) includes a number of settings and data protection devices that, along with the System5 Base and Scout, will give the user a compliant system if adopted into their SOP’s.  The software can control the access to areas of the software by individual user by means of Administrators who can set up and allocate individual users with their own unique access levels to the software.  However it is always the organisation’s responsibility to make sure that any particular user is responsible and understands that any document he/she signs using this software under a 21 CFR environment is the equivalent of a handwritten signature.

Windows Authentication

System5 uses Windows NT Authentication as a basis for ensuring that only bona-fide users have access to changing of any settings. There is no method within any part of System5 for any user to change any recorded values.

Electronic Signatures

The electronic signature can only be added by users with the specific function allowed in their profile and contains all the required elements: name, date, time, reason for signing and authority to sign. This signing always takes place immediately before output of a document in printed or electronic format. Furthermore any user must supply his/her authentication credentials each and every time a document is generated.

Audit Trails

Along with Electronic Signatures a full audit trail has been included with the software that gives a record of all changes to system parameters by those users who have logged into the System5 software. This is an essential part of record keeping in 21CFR Part 11 environments.

Closed System

It is assumed that System5 is used within a 'closed system' i.e. an environment in which system access is controlled by persons who are responsible for the content of electronic records that is on the system.

21CFR Part 11 Policy Statement

Silvertree Engineering does not at any time imply that the use of this software package and IceSpy loggers will automatically give the customer protection and compliance with the 21 CFR Part 11.  The FDA is very strict on this.  The System5 software from Silvertree Engineering is designed to be integrated into the SOP’s as part of a 21 CFR Part 11 system.  A number of tools have been put into place in order to provide an excellent basis for complying with the requirements of 21 CFR Part 11.  If the SOP’s are updated to include the use of System5 software and loggers then compliance is not guaranteed but it will be more likely.  In any case the system in place will need to be discussed with an FDA Auditor.  System5 is a vital link in the path to compliance.

Scout ScoutPlus Base BasePlus System5 PC Software