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Regulatory Compliance. Be Ready.

Pharmaceutical and biotech compliance regulations change as often as the weather. Right now it’s raining new aggregate spend compliance rules in several states. We’ve been seeing  a blizzard of off-label promotion enforcement hitting the entire industry. And just when you see sunny skies ahead, an ominous cloud of FDA officers concerned about system validation and samples management practices appear.

How can you solve a problem that’s constantly changing?

Move your company to the Cloud. With Veeva System’s multi-tenant SaaS CRM system built in the Cloud, you’re always ready for what’s next when it comes to compliance (or anything else). Veeva CRM’s unique architecture allows for rapid, behind-the-scenes upgrades every 90 days so your system is always up to date with the latest business rules and reports. And, you can make adjustments to your system that reflect new or changing compliance regulations quickly – all for less than the cost of a new umbrella.

No more waiting months (or years) to make changes to your application. No more shelling out millions of dollars to develop a new version of your system with updated compliance parameters only to be obsolete by the time it rolls out months later. With Veeva CRM, updates are fast, free, and painless because it all happens without disrupting your existing data, functionality, or users. It’s transparent. Automatic. Every 90 days.

Here are a few ways the Cloud can help your compliance efforts:

• Off-Label Product Promotion Compliance
• System Validation & Samples Management
• Aggregate State Spend Regulations

Off-Label Product Promotion Compliance

Veeva’s multi-tenant SaaS CRM system can include parameters that will help ensure reps are appropriately distributing drug samples, discussing products, and handling physician requests for medical information. Veeva CRM guides the salesperson when detailing products so that he or she knows exactly what information can be communicated to which physicians, what samples can be signed for, and what content can be shown to a given physician based on the physician’s training and certifications and the approved uses of company’s products. Built on the cloud computing model, Veeva CRM allows all of this information to be changed as often as needed to reflect changes in compliance regulations.

System Validation & Samples Management

Veeva CRM is the only CRM application pre-validated for PDMA and the Food and Drug Administration’s CFR Part 11 compliance with complete IQ and OQ documentation for safe sampling. Veeva partners with Q Pharma, a leader in regulatory compliance consulting services to the life sciences industry, to validate our standard Veeva CRM system before the application is in use, saving customers up to 80% of system validation costs. Perhaps more importantly, ongoing validation reduces the risk of our customers being issued a damaging consent decree from the federal government. The product’s multi-tenant SaaS architecture enables the vendor to routinely check, re-validate any changes, and upgrade all users simultaneously. Again, the updates are free.

Aggregate State Spend Regulations

Last year, dozens of states enacted legislation mandating life sciences companies track and disclose their sales and marketing expenditures at the physician level. Each of these states has different reporting requirements and defines spending in different ways. When these rules change (and they will), you need a system flexible enough to make the necessary changes to remain compliant from state to state and month to month. The system’s aggregate spend indicator feature enables state-spend compliance for each account. When recording a call, a sales representative can spot accounts approaching state spend limits and reduce their promotional item distribution.