FDA Audits Don’t Wait
for IT to Catch Up.

21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures. It applies to your company if you use electronic systems to create, modify, maintain, archive, retrieve, or transmit records required by any FDA predicate rule — such as good manufacturing practice regulations under 21 CFR Parts 210/211, medical device regulations under Part 820, or food safety regulations. If you submit data to the FDA electronically, Part 11 almost certainly applies. The moment a LIMS, ELN, or chromatography data system generates a record used to support a regulatory submission, Part 11 obligations begin.

Computer System Validation (CSV) is the documented process of proving — through testing and evidence — that a computerized system consistently does what it is intended to do in a regulated environment. If your LIMS manages samples, generates test results, or creates data that feeds an FDA submission, yes: it must be validated. The level of rigor scales with criticality. IT Center helps scope the validation effort and ensures underlying infrastructure changes (server moves, OS updates, virtualization migrations) do not inadvertently invalidate your system.

GxP regulations impose specific requirements on IT infrastructure that hosts or connects to regulated systems. Servers running validated applications require documented change control — you cannot apply Windows patches or migrate to a new VM host without assessing the impact on validation status and potentially re-executing qualification scripts. Network changes affecting validated instruments must be documented. GxP-aware IT management means treating your infrastructure as part of the validated system, not a separate administrative concern.

If you are an early-stage company, you likely do not need your own SOC 2 certification yet. However, you do need to verify that the SaaS vendors and cloud providers you use have SOC 2 Type II certification, because your quality system requires you to qualify your suppliers. When pharma sponsors or CROs perform vendor audits, they will ask what cloud platforms you use and whether those platforms have current SOC 2 attestations. IT Center helps you evaluate vendor SOC 2 reports and maintain a qualified vendor list as your company scales.

Retention requirements vary by record type and applicable predicate rule. Under 21 CFR Part 211 (pharma manufacturing), batch production records must be retained for at least 1 year after product expiration or 3 years after batch distribution. Under 21 CFR Part 820 (medical devices), device master records must be retained for the useful life of the device or at least 2 years after commercial distribution. For clinical trials under 21 CFR Part 312, essential documents must be retained for 2 years after IND discontinuation or marketing approval. In practice, many companies target 6+ years as a conservative standard. IT Center configures backup systems with regulatory retention schedules and maintains immutable off-site copies with documented backup integrity evidence.

Yes. IT Center prepares an IT-specific audit readiness package that includes: current network diagrams with validated system identification, user access review documentation, audit trail samples demonstrating Part 11 compliance, backup logs and recovery test evidence, change control records for all infrastructure modifications affecting validated systems, and a system inventory with validation status for each Part 11-scoped application. We also conduct a pre-audit walkthrough to identify IT-related findings before inspectors arrive. When the FDA or a sponsor audit team reviews your IT controls, your documentation is organized, current, and defensible.