A 480-person software company running cold-chain logistics for pharmaceutical customers had a compliance problem that spreadsheets and shared drives could no longer contain. Five people were managing ISO 27001 and ISO 9001 across disconnected systems, with pharma-specific regulatory requirements that no off-the-shelf tool could handle without customization. When a lower-cost competitor arrived late in the evaluation with an aggressive price, the team had already spent weeks validating a different answer. The proof of concept had done its work, and the outcome was never really in doubt.
[ The Problem ]
Five People. Two ISO Frameworks. Three Disconnected Systems. One Ticking Clock.
A small compliance team was managing ISO 27001 and ISO 9001 manually across SharePoint, Jira, and spreadsheets, with no integration layer connecting any of them. Risk assessments, policy management, and vendor oversight each ran on separate manual processes, creating duplicative effort and compounding audit preparation risk.
The complexity did not stop at standard frameworks. Pharma-specific regulatory requirements — Annex 11 and Part 11 — demanded custom compliance workflows that no generic GRC tool could support out of the box. The team had set a six-month implementation deadline, signaling that the cost of inaction was no longer theoretical. For a company operating in regulated pharmaceutical logistics, a compliance gap carried direct commercial consequences with its customer base.
[ What they needed ]
The compliance team needed to accomplish several things at once, within a fixed window:
- Consolidate ISO 27001 and ISO 9001 workflows onto a single automated platform
- Replace manual evidence collection across SharePoint, Jira, and spreadsheets
- Build and maintain custom compliance frameworks for pharma-specific regulatory requirements
- Integrate with an existing stack spanning AWS, Azure, GitLab, Jira, Intune, and Hibob
- Establish vendor risk management and risk assessment workflows without adding headcount
- Create a Trust Center to handle external security inquiries from pharmaceutical customers
- Complete implementation within a six-month window with a five-person team
[ Why Drata won ]
Selected over Vanta, a lower-cost alternative that arrived after the proof of concept had already validated Drata's integration depth and framework automation against the team's live environment.
Proof of concept credibility: Vanta entered the evaluation after the team had spent three and a half weeks running a controlled POC across their actual stack. Switching to an unvalidated alternative for cost savings alone carried too much implementation risk against a fixed six-month deadline. The POC converted technical validation into vendor selection before the competitive challenge could gain traction.
Custom pharma framework support: Annex 11 and Part 11 compliance requirements were non-negotiable for a company operating in regulated pharmaceutical logistics. Drata's custom framework builder addressed this directly. A lower-cost platform without equivalent customization capability was not a viable substitute regardless of price.
Integration coverage across the full stack: Native connectors for every system in the team's environment, confirmed live during the POC, meant implementation could begin immediately. The operational value of reduced onboarding time was concrete and visible in a way that a price comparison alone could not displace.
[ How Drata solved it ]
Drata GRC replaced the fragmented manual workflows with a unified compliance automation layer, connecting directly to the team's existing infrastructure through native integrations across AWS, Azure, Azure AD, GitLab, Jira, Intune, and Hibob. Control readiness automation for ISO 27001 and ISO 9001 eliminated the duplicative manual processes that had consumed the team's capacity.
The custom framework builder, available through the Enterprise tier, addressed the pharma-specific requirement directly: Annex 11 and Part 11 compliance workflows were built to specification rather than approximated through workarounds. Drata TPRM brought vendor oversight into the same platform, removing a separate manual process entirely.
Drata Trust Center gave the company a structured way to respond to security inquiries from pharmaceutical customers without pulling the compliance team into individual questionnaire responses. A structured proof of concept, run across the team's live environment, confirmed that pre-established integrations would significantly compress onboarding time and reduce implementation risk against the six-month deadline.
[ Before and after Drata ]
Before Drata, a five-person team was managing two ISO frameworks and pharma-specific regulatory requirements manually across three disconnected systems, with no path to scaling without adding headcount.
After, a single automated platform covers ISO 27001, ISO 9001, and custom pharma frameworks, with native integrations across the team's full stack and a Trust Center handling external security inquiries from pharmaceutical customers.
[ Business outcome ]
The compliance team moved from three disconnected manual systems to a single automated platform covering both ISO frameworks and pharma-specific regulatory requirements. Custom framework automation for Annex 11 and Part 11 eliminated the manual overhead that no generic tool could have absorbed.
The six-month implementation timeline the team had set as a hard deadline became achievable. Integration depth validated during the proof of concept meant onboarding could begin immediately rather than after a lengthy configuration phase. Audit readiness shifted from a resource-intensive manual effort to a structured, automated workflow the five-person team could sustain without additional headcount.