Computerized Systems (CS) using Programmable Logic Controllers (PLC) are utilized for controlling manufacturing equipment. Such a CS is referred to as a PLC-Based CS (PBCS).
Proper workability and operability of CS has become more important to prove that poor quality drugs are not being produced due to the malfunction of CS. The regulatory authorities require drug production companies to prove that their processes and CS that controls such processes, are adequate to produce high-quality drugs, by showing evidence based on documents or electronic data regarding drug development and verification.
Medival use a pragmatic, integrated approach to commissioning and validation activities – ensuring sound documented compliance with cGMP for all our assignments.
Medival offer full validation services associated with manufacturing projects and offer services to retrospectively validate existing manufacturing processes. Medival assist you with the interpretation of regulations in determining the validation requirements, manage implementation of methodologies, and prepare necessary reports.
Our validation approach is based on current GMP, GLP, GAMP 5, ISO, and 21 CFR Part 11 regulations. Our experienced staff will ensure that protocols are written and executed according to user requirements, specifications, applicable regulations, and SOPs.
Medival provide operational resources and assistance with the generation of User Requirement Specifications (URS), through Commissioning and Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
21 CFR Part 11 Assessment
Risk Assessment Protocols And Reports
User Requirement Specification (URS)
FRS / CS
Design Qualification / Design Specification
Installation Qualification Protocols And Reports
Operational Qualification Protocols And Reports
Performance Qualification Protocols And Reports
Standard Operating Procedures (Sops)
Requirement Traceability Matrix (RTM)
Validation Summary Report (VSR)
FAT And SAT Protocols
If you have any specific questions about us or any of our services, get incontact with us.