Document management

Effectively create and manage your standard operating procedure (SOP)

SOP

According to the cGMP (Good Manufacturing Practice) manufacturers must properly maintain proper documentation and records as they define the manufacturers system of information & control, to minimize the risk of misinterpretation & errors inherent in oral or casually written communication, to provide explicit procedures to be followed to provide confirmation of performance, to allow calculations to be checked & to allow tracing of batch history. Effective document management is a reflection of quality system.

Most of the MES does not includes the procedures/checklist related to specific area and equipment as they increase the frequency of MPCR versioning which in turn increasing the man efforts compare to manual  system.

And, on other hand ProcessXE allows the selection of SOPs as per the availability of areas and equipment for manufacturing the batch without increasing the frequency of MPCR versioning.
Over and above ProcessXE automatically sets SOP execution sequence on the basis of their title and area and also makes sure that always effective SOPs are only available for batch manufacturing.

Process XE – Document management software key highlights

  • Integrated with BPCR for batch manufacturing
  • Automates the creation reviews and approval of SOPs across a global network with readymade templates
  • Real time tracking of SOP lifecycles like who needs to review it, approve it, who currently holds the SOP
  • Effective version control ensures that operators always have effective SOP for manufacturing the batch
  • Reports for SOP version history
  • Option to show flow diagram and images in SOP for easy interpretation of audience
  • Execution sequence of SOPs with respect to other unit operations will be automatically set on the basis of SOP title and area
  • Control copy release of SOP for hardcopy review
  • Electronic signatures for authentication of activity
  • Audit trails for data integrity
SOP key highlights

Process XE – Document management software key benefits

Speed up
product release
Reduce compliance
and operating cost
Enhance accuracy,
productivity and transparency
Enhance
management visibility
Improves
decision making