FORMULATOR Software, LLC certifies that FORMULATOR provides the software functionality and auxiliary tools to completely and fully facilitate end-user compliance with applicable rule requirements within current FDA “Guidance for Industry Part 11, Electronic Records”, as follows:

Subpart B – Electronic Records, Sec. 11.10  Controls for closed systems

(a) Validation.  We certify that all equation functionality, property bases, and unit of measure bases have been fully validated by hand testing of formulation data provided with the demonstration database(s).  The user can apply this method to validate any equations, properties, or units of measure that they add to the software via the set-up screens provided.  There is no functional opportunity for the user to manipulate or change the calculation results once the calculation has been performed.

FORMULATOR^Ô provides simultaneous viewing access to the following (including details): All properties; all units of measure; all equations; all QC tests; all boilerplate instructions and device interface codes / LIM logic.  Records are displayed and highlighted during editing functions allowing the user to validate data before and during the editing process as editing is performed.

Whilst the above windows are displayed, the user can review all raw materials and their properties, and view any given formulation at the same time, within Formulation maintenance or via the tree viewers.  The tree view editor provides the user the ability to view and record unit conversion and multi-level quantity summary validation.  These software utilities also provide the ability to validate the CAS breakdown for REGULATOR^Ô.

User accessible data is date, time and user ID stamped for add and update.  Logs may be selectively created for each database / company, depending on end-user preferences.

1. Comprehensive reports are provided with the FORMULATOR^Ô system software. Printouts are available for all data entered and saved into the system to allow hard copy documentation and retention of data.  FORMULATOR^Ô data is always contained within an SQL^* database of the user’s choosing, and all reports are provided in Seagate Crystal Reports RPT format.

1. .  While largely an end-user procedures issue, FORMULATOR^Ôprovides a complete formula logging and restore system that lets the user “undelete” formulas and raw materials, or completely restore (or clone*) them back to a previous state.  We recommend a nightly backup of the entire database, and also recommend preserving multiple backups off-site.

1.  FORMULATOR^Ô access is controlled by several means.  Within the application, each user has a unique login with predetermined access levels to the functions of FORMULATORÔ set by an authorized administrator.  The passwords are stored ‘in the clear’ using a 128 bit fractal hashing algorithm.  Each successful logon is stamped with a unique session ID and in/out times are logged in the system database.  All formulation activity is traceable back to this session ID (logging of user IP address, domain, ARP, or other system aspect is NOT covered in the base version).  The full SQL* version provides GRANT and REVOKE privileges synchronized with the user maintenance module for enhanced SQL* security with minimal impact on the database administrator.

1.   All formulation changes are logged real-time within the database.  This includes the ingredients, QC preparation narrative and images, QC standards, properties, and shipping information.  A complete application data log is also available, at the user’s discretion.  This option selectively saves all the SQL* input sent to the FORMULATOR^Ô

1.   FORMULATOR^Ô has only one true workflow-type operation, the QC process.  QC results begin when a batch ticket is printed.  QC then enters results against this ticket.  If you attempt to re-print the ticket, you will either be prevented, or warned against it, depending on how your database is configured.  The other FORMULATOR^Ô workflow instances are contained within single modules, and may be validated visually by using the application (i.e., reverse calculation, search and replace, etc.). Additional checks include preventing you from deleting a raw material that is contained in a formulation.

1.  FORMULATOR^Ô allows each user to be assigned an authorization level for each module in the main menu.  These act locally, with the exception of the Raw Materials editor.  If you set up a user with no access to ‘Costs’ within the Raw Material module, that user will typically not be able to see any costs anywhere at any time, no matter what module they are running.

Some major edit and analysis modules, such as Raw Material and Formulation Maintenance, allow further sub-authorizations within each editor.  For instance, you might allow a user read-write access to the main formula screen and ingredients, but you may prevent this same user from altering, or perhaps even viewing, QC standards or other aspects of the formulation.

1.   While FORMULATOR^Ô can provide device authentication to virtually any user specification, typically this section falls into the realm of custom end-user requirements.  Signature Pad authentication is available as an additional function.  Further development would be needed to meet any specific requirements in this area.

Paragraphs (i) through (k) are the responsibility of the end user.

Subpart C – Electronic Signatures, Sec. 11.300  Controls for identification codes / passwords

1.  FORMULATORÔ enforces a one string – one user policy that is case insensitive.

1. Password aging and (d) Unauthorized access attempts. The base version of FORMULATOR^Ô does not enforce application level password length, re-use prevention, and does not provide password aging / freshness logic or logon date / time / count restrictions.  It does not shut an account down after a given number of bad logon attempts.  All of these functions, however, are generally available, at minimal cost, depending on client specific requirements.

*Note: 1) Cloning is a standard FORMULATOR function available within all application and system editing components.  Simply put, it means to save the contents of a given editor to a new code number.  2) All FORMULATOR I/O is based on ANSI Structured Query Language (SQL).