For leaders in Pharma looking to implement a technology solution, one of the first considerations is validation—Can the system be validated, should it be validated, and what steps does it take to validate?
What does Validation mean?
Computer System Validation can be a complex topic—subject to many international regulations, proprietary internal policies, and industry best practices.
At risk of oversimplifying, it means that measures are put in place to ensure that the system or software produces accurate and consistent results. For software that handles certain important records, it also means that information is maintained with a full history of any changes, and an audit trail of the parties making said changes—this is the guiding principle of the FDA’s 21 CFR part 11, for example.
Why do our Customers Validate?
In their own words, noncompliance is “just a mess if you are audited.”
To put this in perspective, the alternative to many of Orbit’s products are home-grown solutions—generally a mix of SharePoint, Excel, and elbow grease that are all but impossible to validate. In these cases, Pharma companies must choose whether to risk non-compliance with validation rules, or not to store the records in these systems at all. (The phrase “a rock and a hard place” comes to mind.)
Frankly, these home-grown solutions are not exactly easy to manage if you face a safety inspection or an audit.
Working in a regulated industry for years, Orbit takes validation of our products very seriously and understands the need for maximum traceability and accountability. Each module of the Orbit Software package is extensively validated, covering all facets of the software. Every major release is tested and validated in-house by our own QA, not a hired third party contractor.
If you are still tracking your Risk Management plans in Excel, reconcile your AE Reports via email or simply need state of the art traceability to comply with audits or safety inspections, we are here for you.