Zontec Inc. now offers a Statistical Process Control (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:
- Utilizing e-records which are less expensive and more accessible than paper records
- Stronger security by incorporating e-signatures instead of handwritten signatures
- Saving personnel time from developing in-house validation materials
- Increasing productivity and confidence as a result of applying proven SPC software materials that meet regulatory standards and requirements
- Cost of compliance is low compared to recalls, penalties and fines