Periodic Verification/Calibration of the measuring instruments is vital for Quality Assurance and to guarantee the reliability of data generated.
Assist with Regulatory Compliance
Periodic Verification/Calibration or performance of Suitability Tests is required by regulatory agencies or certification companies. For compliance with regulatory requirements, actions are performed by Merck's specially trained engineers and are documented with Standard Operating Procedures, reports and/or protocols. All instruments used during these procedures are calibrated (if required) on a regular basis.
Qualification & Validation
Merck offers a Qualification Program for water purification systems. Designed to facilitate laboratory validation procedures, the program includes qualification workbooks with Installation Qualification (IQ), Operational Qualification (OQ), Maintenance Procedures (MP), examples of Performance Qualification (PQ) files, and certificates of Conformity, Quality and Calibration in support of compliance with GLP* and cGMP**. These Qualification protocols are carried out by Merck's specially trained and certified Field Service Engineers.
In addition, some of the new Merck Lab Water Systems now have electronic data registration protocols compliant with FDA 21 CFR Part 11 requirements.
*Good Laboratory Practices
**current Good Manufacturing Practices
On-site services for pharmaceutical, biotech, chemical labs, etc.
- Documentation for GLP and cGMP compliance
- Support for IQ, OQ, MP and recommended PQ protocols
- Access to certified Field Service Engineers