Validation documentation services
We can supply the scope of documentation you need for your validation process
Integrity and compliance are embedded in our process from the outset — we provide comprehensive documentation and support to ensure client peace of mind regarding the integrity and compliance of the labelling process.
Our validation documentation process is entirely customer-centric and driven by our expertise in navigating the complex landscape of regulatory compliance. We start by closely collaborating with the client to understand the unique User Requirement Specifications (URS). This dual focus forms the foundation of our documentation and validation efforts to ensure that client and legislative needs are met.
We follow a meticulous URS Design Specification (URS-DS) cross-reference list to ensure that every requirement is met. Our factory acceptance testing (FAT), site acceptance testing (SAT) and Installation Qualification/Operational Qualification (IQ-OQ) test protocols and reports are conducted rigorously to exceed expectations.
Our team possesses an in-depth understanding of our equipment, enabling us to streamline the validation process. While external consultants are often brought in for validation, our in-house expertise ensures an efficient and effective validation process that seamlessly meets requirements. This allows us to provide a documentation and validation process that is tailored, thorough, risk based (FMEA) and customer-focused.
-
LSS offers tailored validation documentation packages according to the cGMP and GAMP 5 regulations
-
The documentation certifies that the equipment has been designed, built and operates according to your URS requirements
-
The validation packages are composed by DS, DQ, IQ/OQ and FMEA risk analysis
1. Design Specification
- Design specification
- Design Review with customer
2. Basic Documentation package
- Quality Activity Plan
- Design Specification incl. design review
- URS – DS cross reference list
- FAT & SAT Test Protocol & Report
3.Extended Documentation package
- Quality Activity Plan
- Design Specification incl. design review
- URS – DS cross reference list
- FAT & SAT Test Protocol & Report
- IQ Protocol, based on customers specification in the URS (Q or C indication)
- OQ Protocol, based on customers specification in the URS (Q or C indication)
4.Validation Documentation package
- Quality Activity Plan
- Design Specification incl. design review
- URS – DS cross reference list
- FAT & SAT Test Protocol & Report
- Validation Plan
- Risk Management Plan
- FMEA risk analysis performed according to the Machine Design Specification and the product criticality (determined by the customer).
- IQ Protocol prepared according to the FMEA
- OQ Protocol prepared according to the FMEA
- Validation Summary Report
Other solutions for pharmaceutical products
Would you like to know more about labelling solutions for the pharmaceutical industry?
Contact our experts
