Run right-first-time batches with records ready before the auditor asks
Get batch records review-ready, logbooks searchable, and approved SOP changes to operators sooner.
Pharma operations have to keep changing, and each change carries compliance risk. Keeping up takes a system that holds controlled steps steady while leaving room to improve the rest.
Tulip is a composable frontline operations platform used to implement a composable MES. It works alongside your ERP, QMS, LIMS and existing MES, so teams capture the record at the point of work, on one data model across lines and sites.
Automated data capture, eSignatures and equipment integration build the batch record as the work happens, so QA can review by exception. Batch records reuse shared process steps, which cuts duplication.
Logbooks linked to equipment by QR code update status automatically and show who cleaned, used or maintained it, and when. Central search replaces digging through archived paper before an inspection.
Guided dispensing connected to scales and meters checks tolerances live, and a step can't be completed until it's verified. Each dispensing step is recorded as it happens and attributed to the operator who did it.
Guided steps show operators what to clear, check and sign before the next product runs. Each step is recorded at the point of work, so QA has the evidence in hand when it reviews the clearance.
Verification steps, device readings and conditional gates put in-process controls inside execution, with out-of-tolerance alerts at the step. Deviations are captured at the point of work, before the batch has moved on.
Lab methods are guided step by step, and results flow from lab instruments straight into the record and LIMS. Removing manual transcription closes off a common source of data integrity risk in QC.
Improve inside validated guardrails, keep one audit trail from SOP to batch release, and repeat what works at the next line or site, whether the alternative on the table is a traditional pharma MES, a QMS stretched into execution, generic low-code tools, or paper and spreadsheets.
For teams moving to CSA, Tulip's intended-use validation approach, aligned with GAMP 5, and its separate development, validation and production environments let you improve a process without revalidating the whole system. AI Composer can turn an existing SOP into a first working version, which goes through your approvals before it reaches validated production.
Your QMS keeps document control and CAPA. Tulip is where the SOP becomes the workflow and the audit trail is created as the work happens, with each entry attributed to a user and time-stamped. Built-in audit trails, e-signatures and traceability satisfy 21 CFR Part 11 and Annex 11.
Once a process runs right, carry it to the next line or site without rebuilding it. A central team holds the standard while each line or site adapts locally, and IT doesn't have to build compliance infrastructure from scratch.
AstraZeneca replaced paper-based packaging changeovers with digital, operator-centric workflows, built on a global standardized logbook and master data models.
"Tulip is sort of the quintessential tool to enable augmented lean. Applying Tulip to changeover is exactly what we mean by lean digital."
Eli Lilly replaced paper logbooks and forms with a validated Dynamic Forms app suite, going from requirements to validated production release in three months. Governance stays central while each site adapts its own forms.
"We validated the apps, we have a validated data model sitting behind this, but the business can then take these applications and start building their forms."
Jazz Pharmaceuticals digitized its paper logbooks first, then redesigned wider GMP workflows, with up to $120k avoided through deviation prevention.
"We did what we thought was an MES RFP at the time, and when we did the readout, we realized we didn't need the full breadth of an MES."
Pharmaceutical manufacturers generally need software that captures GMP records at the point of work, supports validation to intended use, and connects to the ERP, QMS and LIMS they already run. Tulip is a composable frontline operations platform used to implement a composable MES. Teams typically start with the workflow that hurts most, such as logbooks or batch records, prove it with working software, and expand from there.
Look for electronic batch records with review by exception, audit trails and eSignatures that meet 21 CFR Part 11 and Annex 11, validation scaled to intended use, connections to ERP, QMS, LIMS and lab instruments, and a way to start with one use case before committing to more. In Tulip, these run on one governed data model, with separate development, validation and production environments, so a new use case is validated before it reaches production.
Most teams get there one workflow at a time, starting where paper causes the most review effort or transcription errors. With electronic batch records, connected equipment feeds data in automatically, operators record each step at the point of work, eSignatures sit where a step needs one, and QA reviews by exception. Cellares, a cell therapy manufacturer, replaced paper-based manufacturing with digital eBR and process review apps.
Under a risk-based approach such as FDA's Computer Software Assurance guidance, validation effort scales with a change's intended use and risk. Tulip's intended-use validation approach, aligned with GAMP 5, and its separate development, validation and production environments let teams iterate within validated guardrails without revalidating the entire system. Changes still go through your approvals and change control before they reach production.
21 CFR Part 11, like Annex 11, sets requirements for electronic records and electronic signatures, so any system that replaces paper GMP records has to meet them. Tulip provides built-in audit trails, e-signatures and traceability that satisfy 21 CFR Part 11 and Annex 11, and data captured in Tulip is automatically attributed to a user with a time and date stamp. Customers validate their apps to their intended use.
Manual transcription between instruments, LIMS and paper is a common data integrity risk in QC labs. Connecting instruments directly and guiding each method step by step lets results flow into the record without retyping, so review can focus on exceptions. Organon digitized QC lab methods integrated with LIMS and instruments, and saw a 20% reduction in hands-on execution time for its KF moisture method.
Deviations tend to surface late when checks happen after the fact on paper. Building in-process controls into execution, with verification steps, device readings, out-of-tolerance alerts and conditional gates, flags a problem at the step where it happens. In Tulip, the deviation is captured at the point of work. Jazz Pharmaceuticals, which moved from digital logbooks to wider GMP workflows, reports up to $120k avoided through deviation prevention.
CDMOs usually need validated, audit-ready systems for each new client on a short timeline, with traceability, change control and Quality Agreement compliance for each one. In Tulip, multiple instances and governed change management make per-client audit readiness repeatable, so a proven process can be replicated for the next client without rebuilding it. NextPharma, a CDMO, replaced its paper batch records with Tulip digital workflows.
Yes. Your ERP stays the system of record for materials and orders, your QMS for document control and CAPA, and LIMS for lab data, while Tulip handles operator execution, in-process quality and instrument connectivity. Where a pharma MES already runs formal eBR, Tulip can be the operator-facing layer alongside it. Tulip connects through APIs, databases and common OT protocols, with encrypted traffic, least-privilege access and network segmentation.
Tulip is delivered as a qualified platform, with validation documentation for each long-term support (LTS) release, and GxP Mode adds stricter controls. Enterprise organizations in regulated industries typically run LTS releases and qualify each one before upgrading, and they don't have to revalidate the entire platform after every update. Validation focuses on each app's intended use.
In GxP work, AI is generally safest to start with on the authoring side, where a person reviews each output before it's used. AI Composer turns existing SOPs into a first working app, which goes through review and approvals before it reaches validated production, and AI App Translation keeps translated versions of an app in step with the source app for multilingual sites. Operational data isn't retained by LLM providers or used to train their models.
See how pharma and biotech manufacturers keep records ready for QA review with electronic batch records, GMP logbooks and in-process controls.