Electronic signatures that replace paper copies of hand-written signatures. SPC Software can handle eSignatures.


Zontec Offers New SPC Software Validation Service

Synergy Software Validation User Acceptance Testing Protocol.

Synergy Software Validation

Cincinnati, OH—May 7, 2013 —Zontec Inc. the international developer of Statistical Process Control (SPC) software solutions, today announced a new Synergy SPC software validation service to its customers.

“This package will be invaluable to our customers and prospects regulated by the Food and Drug Administration (FDA) 21 CFR Part 11,” said Zontec President Warren Ha. “We developed this service to aid companies in the food, healthcare, pharmaceutical, medical device, and other industries to meet the required regulations.”

The Zontec Validation Package includes a User Acceptance Testing (UAT) Protocol template, and a UAT Report template to meet the regulatory requirements for electronic recordkeeping and electronic signatures. The key components of the UAT Protocol template consist of the requirements, specification of the system configuration and security, and test cases that demonstrate correct system operation.

“This service provides customers with two options: we provide customers the materials necessary to perform their own software validation or we perform it for them,” noted Ha.

Benefits of using Zontec’s Software Validation Package:

  • e-records are less expensive and more accessible than paper records
  • e-signatures are much more secure than handwritten signatures
  • Personnel time saved from developing validation materials
  • Proven SPC software materials that meet regulatory standards
  • Adherence to regulatory requirements causes increased productivity
  • Cost of compliance is low compared to recalls, penalties and fines