Ready for incorporation in FDA submissions according to CFR 314 etc.
To analyse fragments compliant with Good Laboratory Practice (GLP) as specified for non-clinical laboratory studies, Eurofins MWG Operon offers its GLP-compliant sequencing service. You have the choice between two kinds of qualities (2-fold and 4-fold coverage). All processes are performed according to proprietary standard operation procedures.
The sequence is determined on both sense and antisense strands by starting with two primers, then sequencing using primers derived from the ends of the determined DNA sequences until the whole insert/fragment is sequenced on both strands.
The availability of a reference sequence can further speed up the process as this enables us to define multiple primers from the start. Our in-house DNA synthesis production site enables us to offer you the fastest possible delivery times. To ensure the quality of our GLP-compliant sequencing service we are routinely assessed by 1st and 2nd party audits and regularly perform process audits.
- Detailed strategy supervised by personal study director
- Quality control of incoming DNA
- Design and synthesis of specific primers included
- Validation by internal quality control standards (DIN EN ISO 9001:2000)
- Assembly of the sequences on the basis of Q30 monitored single strand data included
- Manual quality check and report for the generated consensus sequence
- Guaranteed accuracy of final data: 2-fold coverage > 99.999%; 4-fold coverage > 99.99999%
- Comparison with a reference sequence (if provided)
- Archiving of all study materials and data for minimum one year
- Comprehensive GLP compliant project documentation according to FDA guidelines
- Quality assurance (QA) statement
- Project data transfer at customer’s option
- Convenient online ordering via our Ecom system by choosing the Walking Services order site
- Prepayment option with the EVOcard.
More services can be found in the order menu Additional Services.
