On-line document control systems can present some unique challenges. Some suggestions for your on-line document system are listed below.

• Set up a database to hold procedures and work instructions.
• Organize it using a "Chapter System," with a chapter for each clause of the standard.
• Write procedures and work instructions into the system.
• Give employees appropriate levels of "access"
  • System Administrator
  • Author
  • Editor
  • Approver
  • Read Only
• Have authors write procedures or work instructions.
• Send the document to the editor and approver for approval.
• When it is approved, move it into the "Quality Documents," available to all users
• The documents may be viewed online or printed.
• Control printed documents with a "sunset clause:" use date stamp feature in your system to automatically place the date on documents when they are printed. Documents are valid only on the day they are printed.
• Some hardcopy distribution may be necessary in areas where there is no immediate computer access
  • Keep a master list for distributed documents.
  • Identify controlled hard copies.
• The author makes revisions which must be reviewed and approved by the editor and approver.
• The author must determine if the changes affect any process that is being performed that day.
• If processes use a formula, router or traveler, print it for each lot or batch.
  • Control the document by lot number, batch number, or run number
  • Write the lot number on the document. The document is then valid only for that lot.