ManufactPro™

Design Rationale

The MFP was created to meet the following needs small companies have. It is important to understand these concepts when using the system.Quality System Framework--provides a structure to build ISO and FDA quality systems

Integration-- information from many departments stored in one centralized place.
Organization--information organized in a logical manner.
Control--access and changes by authorize personal only.
Cost-low initial cost. Add more seats as you grow. No mandatory maintenance fee.
Easy-easy to use, understand and change.
Basic--basic features for fast implementation and minimal configuration and quick learning. Build product not mess with software.
Relational-information created and entered once, used many places.
Networked-many people can use the same information at the same time.
Stable--the system runs with little or no maintenance or IT support.
Minimize Paper--print only key quality records for approval and archiving.
Operations/Manufacturing/Production Support-give the most active users of information access in a format they understand and the tools to manage it.
Quality Assurance Support-give the QA users of information access to the same information as operations uses in a format they understand and the tools to manage it.
Reduce errors--auto enter data, data validation and barcodes to prevent errors.
Customizable--easy to change to meet your needs.
Fast Implementation--Import your data from Excel.
Software Validation--the MFP has a standard validation protocol

Barcodes

Using barcodes on labels and forms and a scanner greatly reduces keystroke and transcription errors and speeds up the documentation process. Barcodes print on the labels and forms created in the MFP.

Scanners to use with the ManufactPro system specs:

USB connect, no software to install, laser (no contact and reads lower quality barcodes), low cost.

The HP EY022AA and the Symbol LS2208 meet these requirements and cost about $160.

Amazon.com and Barcodesinc.com sell them along with many other suppliers.

We recommend getting 3 to start: one for doc control, one for stores and one for production.

21CFR Part11 & Electronic Signature

Access & Passwords

The MFP system authenticates individual users based on a two part authentication scheme: username and password. The passwords are encrypted and never decrypted. The user can change their password at anytime. The MFP Security module allows the client (Sys Admin). to specify a minimum password length, expiration of password in days, and deactivation of account in days (in System Preferences). The user can change their password at anytime on the MyPreferences screen. The administrator can reset the password to welcome, but cannot change or view the user passwords The MFP Security module allows the client (Sys Admin). to specify what actions a group or job function can perform in the system using permissions (i.e. Create new Purchase Orders). The administrator assigns users to a group to control their actions.

Electronic Signature

Approvals can be added to any record in the MFP. The client can permit their users to electronically sign or print paper and sign the paper. The client determines and documents their method and the meaning of signatures. The user must log in to the MFP and select MyApprovals to sign. The user can sign records until the re-login time expires and are forced to re-login (Sys Admin assigns default time). The user must choose the meaning of their signature: approve or disapprove. The audit trail reports who signed and for what. Signatures cannot be deleted, they can be removed from the active group, but are always retained for reference.

Audit Trail

The system keeps an audit trail for all log ons, log offs, edits to data and most user actions like locking records or printing forms.
In the opinion of MMC Software, LLC, this meets the current 21CFRPart11 requirements, as of 3/10/2005. Per the FDA software guidelines, each company must establish their own requirements.