Handling pharmaceutical order data means handling regulated data. SRMC's systems are built to meet 21 CFR Part 11 compliant order management standards and PDMA (Prescription Drug Marketing Act) database validation requirements, so every order, sample shipment, and invoice is tracked in a system that regulators recognize, rather than in software adapted from general logistics use.
21 CFR Part 11 Compliant Systems
Our in-house Integral Drug Order Processing (IDOP) system is built around 21 CFR Part 11 principles - electronic records and signatures that are attributable, secure, and time-stamped. In practice, that means every action taken in the system - an order entered, a shipment confirmed, an invoice generated - is tied to a specific user and a specific point in time, and that record cannot be altered without leaving a trace. This means order and shipment data can stand up to audit and inspection, not just internal review, whether the request comes from your own quality team or from a regulatory body.
PDMA-Validated Database
The SRMC Oracle database is validated as required under FDA and PDMA guidelines. For sample and trade product distribution, that validation is what allows brands to demonstrate chain-of-custody and accountability for every unit that leaves our facility. Database validation isn't a one-time certification - it's an ongoing discipline that covers how data is entered, stored, backed up, and retrieved, so that the records your brand relies on for compliance reporting remain accurate and defensible over time.
Audit Trails & Data Integrity
Every transaction in our order management system creates a traceable audit trail - who placed the order, when it was processed, and how it was fulfilled. That level of detail supports both day-to-day quality assurance and regulatory audits when they occur. If a question ever comes up about a specific shipment - where it went, when it left the facility, who authorized it - the answer exists in the system record rather than requiring a manual reconstruction from paper files or email threads.
Electronic Signatures & Access Controls
Consistent with 21 CFR Part 11 expectations, access to the IDOP system is controlled by individual user credentials, and electronic signatures used within the system are tied to those credentials rather than shared logins. This keeps responsibility for each action clearly attributable, which matters both for internal accountability and for satisfying auditors who ask how electronic signatures are protected against misuse.
How This Supports Your Compliance Program
For pharmaceutical brands, a fulfillment partner's data systems become part of your own compliance picture the moment product starts moving through them. A distributor whose systems can't produce a clean, attributable audit trail creates a gap in your supply-chain documentation. Working with a partner whose order management is already built and validated to 21 CFR Part 11 and PDMA standards means that gap doesn't exist - your compliance and QA teams can request documentation and get direct answers rather than working around an unvalidated system.
Data Backup, Retention & Business Continuity
Regulated order data needs to survive more than a single day's operations. Our systems are backed up on a regular schedule with retention practices designed to meet the recordkeeping windows pharmaceutical distribution and sample programs require, so historical order and shipment records remain retrievable well after a transaction has closed - not just for the current reporting period, but for as long as your compliance program needs to reference them.