PLC validation is an essential requirement in industries such as pharmaceuticals, medical equipment manufacturing, genetics research, and biotechnology. Such validation requires extensive documentation such as systems, test information, synopsis reports, and confirmation structures.

PLC validation in pharma or any other industry helps clients get a clear idea about PLC’s reliability to provide control data or information that meets the requirements. Validation can increase the usability and reliability of the system, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to customers and users.

Sondagar comes with decades of experience in performing PLC validation. We specialize in the stringent requirement emphasis GAMP 5 Guidelines, EU Annex 11, and 21 CFR part 11 requirements. We have successfully completed hundreds of PLC validation projects within stipulated timelines.

Why PLC Validation?

  • Reduces risks of failures and accidents to protect your team
  • Increases overall plant performance and delivers better ROI
  • Make sure that the systems are performing accurately to help you provide the best products
  • PLC Validation is a legal requirement in pharmaceutical and other regulated industries and businesses.

Our PLC Validation Services

At Sondagar, we have extensive experience in developing and executing high-quality protocols for the validation of PLC-based control systems. Whether you’re looking to conduct installation, operational or qualification protocols, we have got you covered.

We provide you with a comprehensive validation report package that would summarize all test results, including deviations, the executed protocol, test data, test equipment calibration data, etc.

We provide the following PLC validation services:

  • PLC-based Control systems.
  • PLC-based Control Systems with HMI/MMI user interface+Camera System.PLC-based Control Systems with SCADA.
  • Micro-Controller-based control system.
  • Operating Software for the SCADA.
  • Equipment Validation (Incubator, Stability, etc.)

Computer System Validation Services Deliverables

  • Qualification Doc. : GxP, RA, GAP, CSVP, IQ, OQ, PQ (If required), VSR, Test cases (if needed) etc.
  • Re-Qualification Doc. : RA, Requalification Protocol (Including IQ, OQ, PQ ), Test cases (if required) etc.
  • Re-Validation Doc. : Performance Verification Protocol (Including IQ, OQ), Test cases (if required)

Our Process

PLC Validation is a complex process that involves many steps along the way. We try to break it into small steps to ensure accuracy and speed at every level.

  • Planning & Mapping: Master Validation Plan & User Requirement Specifications
  • Data Collection: Collection Of Raw Data Information And Required Reference Documents
  • Assessment: Performing Gxp Assessment, Risk Assessment & Gap Assessment
  • Reports/Protocols: Generation Of Protocols/Reports (IQ, OQ & PQ) & Execution Of Protocols/Reports (IQ, OQ & PQ)
  • Testing: Defining acceptance Criteria & Preparing Deficiency Report
  • Performing Changes: Executing Corrective Action & Preventive Action
  • Final Reports: Final Submission Of All Reports & Validation Summary Report

Why Sondagar?

Sondagar has decades of expertise in performing PLC validation. Our team specializes in various requirements such as GAMP 5 Guidelines, EU Annex 11, and 21 CFR part 11 requirements. We are proud partners to many industries working in multiple domains. Our services come backed by insights gained over decades.

We are not just a PLC Validation company, Sondagar helps you with all aspects of PLC, including PLC programming, retrofitting, maintenance or anything else that you could imagine. We are the all-in-one PLC guys!