ManufactPro Features

Documents

  • Manage document numbers and revisions.
  • Manage the change process
  • Infinite number of documents on a change order.
  • Open the actual documents.
  • View parts related to each document
  • Manage training records
  • Send email reminders for new training
  • Allow employees to maintain their own training records with full audit trail.

Parts

  • Manage all Bills of material, documents, specifications and drawings.
  • Fast searching for parts
  • Duplication of existing bills to save time.
  • Drawings or photos to document the assembly process.
  • Easy and logical entry of lot numbers and operator signoffs-paper or electronic.
  • Automatic part and DHR lot numbering based on your custom scheme.
  • Easy inventory control and reporting.
  • One click purchase orders.
  • One click inspection forms and label printing DHR Batch Records
  • Issue and track LHR/DHR batch records
  • Creates an electronic copy of the DHR as built
  • Send purchase orders to Quickbooks

Lots

  • Track cradle to grave part usage with the eDHR.
  • WIP reports for: parts, assemblies and sterile loads.

Quality Assurance

  • Create and share NCR, Deviations, CAPQ, Complaint and t Returns on the Network.
  • Metric tracking and reporting
  • 60 User customizable field names and forms
  • Easy to alter forms
  • One click link to lots in system.

Equipment

  • Track equipment, preventive maintenance and calibrations.
  • Automatic creation of new work orders based on due date.
  • Extensive reporting
  • History online and searchable.

Orders

  • Enter orders, email a pdf as confirmation
  • Fill and ship the order with lot tracking
  • Return orders
  • Send orders to Quickbooks

System

  • Easy log on processes.
  • Easy set up and management of permissions by groups.
  • Encrypted passwords
  • Forced expiration and deactivation of passwords.
  • 21CFR Part11 Compliant

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.

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.

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