"Bridge The Gap Between Business, Development and Validation"
Problems associated with developing software are amplified within the pharmaceutical industry. During the validation phases (Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ)), any issues found (Quality Incidents (QI)) incur a document and procedural over head that increase the lead time for defect resolution and verification. Compared with similar projects in other industries, pharmaceuticals can take longer to market. As Validation is required for regulatory compliance, business users direct their frustration at development teams.
Typical issues are:
- Higher development costs: Pressure on the IT department to deliver software fixes in a faster turn-around increases the potential for more defects to be introduced into the software and extending the "code-fix-QI" cycle.
- Higher business costs: Delays in the delivery of business software, missed opportunities, missed regulatory compliance, increased Business User time spent on testing and delays in daily business user tasks.
- Low morale and confidence in Development: Increased delays and costs results in added pressures on Business Users and IT department staff. Business Users cannot understand why the IT department cannot deliver and the IT department cannot understand why Business Users change their mind.
- Increased risk of issues being revealed in production: Validation do not have the skills to technically test (verify) software. This means that visibly correct software can be released into production laced with technical problems, such as performance issues.
EQE can provide the same benefits that are offered to other industrial sectors while enhancing the regulatory compliance of the pharmaceutical industry.
Right First Time Validation
EQE's approach is to apply robust quality assurance and technical techniques to the development approach in order to reduce and eliminate the risk of QI's being raised by Validation and reducing the risk of technical issues manifesting in production. Furthermore, EQE will vastly reduce the prospect of the business users changing their mind on delivered requirements. EQE provide a fully traceable, documented approach that is compliant to FDA, MHRA and GxP guidelines. Our Project Appropriate Test Approach evolved from the FDA's least burdensome approach and EQE's risk based testing approach. Here are some of the key points of this approach:
- Re-align the approaches of business, development and validation to ensure waste elimination, co-operation, buy-in and enhanced communication.
- Front Load the development approach with Defect Prevention Techniques that are aimed to identify and capture issues before they are developed into software - thus facilitating earlier and cheaper fixes.
- Adding a distinct Verification Phase to ensure that technical testing occurs in order to reduce the risk of technical issues evading into production.
- Right First Time software is delivered into Validation and so on into production.
- Reduced risk of business rejection of delivered functionality.
With over 5 years of Pharmaceutical experience from the Clinical Trials and Drug Distribution arenas, EQE have the expertise and know-how to reduce the cost of producing regulatory compliant software within teams that are geographically dispersed. Example project work includes:
- Oracle 9i based Clinical Trial distribution management application - off the shelf customisation.
- Web based project management system.
- Automatic Drug re-ordering system.
Please contact us to learn more on how we can bridge the gap between business, IT and Validation and achieve right first time validation.
