Highlights
- •The International Society for Forensic Genetics (ISFG) has convened a DNA Commission to establish validation guidelines for bio-statistical software to be used in forensic genetics.
- •We present recommendations for the minimum requirements to validate bio-statistical software for forensic genetics.
- •Recommendations are provided for developmental validation and the responsibilities of the software developer.
- •Recommendations for internal validation and the responsibilities of the end user are also provided.
Abstract
The use of biostatistical software programs to assist in data interpretation and calculate
likelihood ratios is essential to forensic geneticists and part of the daily case
work flow for both kinship and DNA identification laboratories. Previous recommendations
issued by the DNA Commission of the International Society for Forensic Genetics (ISFG)
covered the application of bio-statistical evaluations for STR typing results in identification
and kinship cases, and this is now being expanded to provide best practices regarding
validation and verification of the software required for these calculations. With
larger multiplexes, more complex mixtures, and increasing requests for extended family
testing, laboratories are relying more than ever on specific software solutions and
sufficient validation, training and extensive documentation are of upmost importance.
Here, we present recommendations for the minimum requirements to validate bio-statistical
software to be used in forensic genetics. We distinguish between developmental validation
and the responsibilities of the software developer or provider, and the internal validation
studies to be performed by the end user. Recommendations for the software provider
address, for example, the documentation of the underlying models used by the software,
validation data expectations, version control, implementation and training support,
as well as continuity and user notifications. For the internal validations the recommendations
include: creating a validation plan, requirements for the range of samples to be tested,
Standard Operating Procedure development, and internal laboratory training and education.
To ensure that all laboratories have access to a wide range of samples for validation
and training purposes the ISFG DNA commission encourages collaborative studies and
public repositories of STR typing results.
Keywords
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Article info
Publication history
Published online: September 04, 2016
Accepted:
September 2,
2016
Received:
August 29,
2016
Identification
Copyright
Published by Elsevier Ireland Ltd.
