Beamex's validation services provide support for pharmaceutical companies in the implementation of CMX calibration management software.
A Beamex validation specialist performs the validation and the customer witnesses the results of the tests. Both people have to sign and date each result.
What is validation and why validate:
Validation is the act of performing series of agreed tests that verify that the software or hardware is operating to the customer's specification (URS) and meets the requirements of regulations, such as 21 CFR Part 11 Electronic Records and Electronic Signatures or GAMP4.
Validated systems are vital for the pharmaceutical industry. The industry is governed by the regulating bodies such as FDA in the USA, EMEA in the EU and national drug agencies in most of the countries.
The agencies have the right to visit a site and carry out an audit to establish that the company are working to agency regulations.
Validation is to proof that a specific system functions as it has been specified. Once a system is validated, it means that it is fit for its purpose and can be used by the customer in a pharmaceutical production or development environment.
Benefits from using the Beamex validation services:
Beamex has the possible knowledge on Beamex products; therefore the validation can be completed fast. A typical duration of the validation is between one and two weeks.
Beamex validation services and validation workbook:
Beamex’s experienced specialists provide full client support from initial consultation relating to the creation of the URS (User Requirement Specification), through to submission of the FDS (Functional Design Specification) that describes how Beamex system will meet the requirements of the URS.
The customer-approved FDS forms the basis of the validation workbook that features various validation tests. These tests are designed to challenge the calibration data and performance integrity and thus prove the robustness of the system in its environment.
Tests include compliance to 21 CFR part11, electronic records and electronic signatures. In case the customer already has dedicated validation team Beamex can offer standard validation workbook.
The validation workbook features almost 50 CMX validation tests covering the main functionality of the software.
More details are available with AMS Instrumentation & Calibration .