TestPro has developed a unique methodology for Quality Management and Control for Software and Hardware systems while being used in the Biotechnology, Pharmacy and Medical Devices Industries.
TestPro Methodology gives full coverage for FDA, CE, IEEE, and GMP requirements while reducing costs and proving ROI.
Our services include:
Testing for various medical system file formats (DICOM).
Validity of the registration.
Writing hazard analysis documents.
Risk analysis management.
Manual vs. Specifications & Requirements Analysis.
Assessing, developing and validating the firm 21CFR Part 11.
Development of SOP - Standard Operating Procedure.
BPR - Business Process Reengineering (Automated Tests).
cGMP Compliance Guidance.
Writing requirements and specifications documents (SRS - IEEE830).
Assessing product requirements for testability and quality (IEEE830).
Assessing product specifications for compliance with Regulatory Authorities Guidelines (IEEE830), Testability and Quality.
Detailed test schedule and resource allocation.
Writing STP - System/Software Test Plan in accordance to regulatory requirements (IEEE829) and in accordance to the New Product Development Procedure (NPD) followed by the firm.
Writing MSTP - Master Test Plan.
Writing tests requirements.
Writing STD - System/Software Test Design (IEEE829).
Writing RTM - Requirements Traceability Matrix.
Writing and performing Tests Cases & Use Cases.
Analyzing the System critical path for prioritizations of Test Case execution.
Analyzing results, writing coherent STRs (System Tests Reports) with emphasis on Critical Sections of the project/system.
Verification & Validation.
Black Box (System-level Tests).
Equivalence Partitioning (in-bound, out-of-bound and on-bound).