Pharmaceutical & Life Sciences

Stop chasing SOP sign‑offs, change controls and training records.

SOPs, batch records, QC documents and regulatory files, controlled inside the Microsoft 365 tenant you already own, in the data region you already chose. Approvals, e-signatures and training acknowledgements in one place, shared securely with CMOs, suppliers and auditors. Built on SharePoint, not bolted on top of it.

Every batch. Every SOP. Nothing leaves home.

SOP-QA-014 Rev 07 effective
Author → QA approval → 148 acknowledged
System Titan Workspace
Runs inside Your M365 tenant
Built for Formulations, API & biologics teams
Status Inspection-ready every day
TRUSTED BY Pharmaceutical Globally
70% faster document search once SharePoint is organized with Titan
50% less time spent on workflows and task management
80% lower cost than building the same on SharePoint with custom development
Research & QC
Research & QC
Production
Production
Packaging & release
Packaging & release
A SOP & Document Control

One controlled home for every SOP, batch record and QC document.

Most quality teams don't fail inspections because of bad science. They struggle because the signed version of a procedure lives in a binder, the draft lives in email, and the training log lives in a spreadsheet. Titan brings the whole document lifecycle under one controlled system.

  • SOPs, work instructions, specifications and protocols taken through draft, review, approval and release
  • Batch record and QC documentation organized by product, batch and site, so the right file is one search away
  • Regulatory submission documents assembled and kept in one controlled library
  • Version control and e-signatures, with older versions kept for reference instead of overwritten
  • Full audit trail of who viewed, edited, approved or acknowledged a document, and when

Works alongside your LIMS, MES and ERP. Your lab and production systems keep the data. Titan controls the procedures, approvals and evidence around them.

SOP-QA-014 · Rev 07 Effective
Line clearance before packaging
Owner Quality Assurance, Site 2
Approved QA Head · e-signed · reason: approval
Supersedes Rev 06 withdrawn, archived
Next review In 24 months, owner reminded
Trained 148 of 152 acknowledged
B Change Control, Deviations & CAPA

Change controls, deviations and CAPAs that don't get lost in email.

Change controls, deviations and CAPAs usually travel as forms attached to emails. Titan turns each one into a no-code workflow with owners, due dates and an approval at every step, built to match your existing quality process.

  • Change control with impact assessment, cross-functional review and QA approval
  • Deviation reporting linked to its investigation, root cause and CAPA
  • CAPA owners, due dates and reminders, so nothing stalls in someone's inbox
  • Each quality event linked to the documents it changed, so the trail is never broken
  • E-signatures and a time-stamped record of every approval
CC-031 · Cleaning procedure
Change control route
  • Raised by Production: complete
  • Impact assessment by Validation: complete
  • QA approval: e-signed
  • SOP Rev 07 issued, retraining assigned
C CMO, CRO & Supplier Portal

Share with partners. Keep the files at home.

Modern pharma runs on partners: contract manufacturers, CROs, API suppliers, licensing partners and distributors. Titan gives each of them a secure guest portal inside your tenant, instead of email attachments and third-party file-sharing links.

  • Quality agreements, specifications and tech transfer packages shared from one controlled source
  • Research and production teams working from the same documents, from development through commercial API manufacturing
  • Each partner sees only their own products, sites and documents
  • Every view, download and signature logged against the partner
  • Bulk guest onboarding: 50 external users in about 20 minutes, instead of 5 days by hand

Built in. Not bolted on. No separate portal to manage, no per-guest license, and no question about where your data is stored.

graph
Partners come in. Your data never goes out.

Where Titan fits across a pharmaceutical business

Quality is where most teams start, but the same platform serves research, production, regulatory and commercial teams without another tool to learn.

Team Who needs access What Titan manages
Formulations manufacturing Production, QA, QC SOPs, batch records, QC documentation, line and equipment procedures
API & bulk drug R&D, production, tech transfer Process documentation shared between research and production, with data integrity across the lifecycle
Biologics & vaccines QA, plant teams, partners Controlled procedures, partner documents, internal and external collaboration
Quality & regulatory affairs QA, RA, auditors Change controls, deviations, CAPAs, compliance documents, regulatory submission files
Sales & marketing Field teams, brand managers Approved product information and sales collateral, shared through Microsoft Teams
Company-wide All employees Intranet, policies, surveys and project and task dashboards

Titan doesn't replace your LIMS, MES or ERP. It organizes the documents, approvals and collaboration around them.

One system, every market

Make it in one country. Ship it to fifty.

A plant in one region, a packaging site in another, partners on three continents and a different regulator for each market. Titan gives every site the same controlled process.

One controlled process for every site, in every market.
One controlled process for every site, in every market.

North America

US · Canada

US FDAHealth Canada

cGMP document control and training evidence for US and Canadian sites.

Europe & UK

EU · UK · Switzerland

EMAMHRASwissmedic

EU GMP document control, with data kept in your European tenant.

Asia-Pacific

Japan · Australia · India

PMDATGACDSCO

PIC/S-aligned document control across multi-country manufacturing.

Middle East, Africa & LatAm

Emerging markets

SFDAANVISAWHO PQ

One process for export sites and partners in fast-growing markets.

What inspectors expect Typical reference What Titan gives your quality team
Controlled electronic records 21 CFR Part 11 · EU GMP Annex 11 Sign-in through your Microsoft Entra ID, e-signatures, version history and audit trails
Data integrity ALCOA+ · FDA, MHRA & WHO guidance Every edit and approval attributed to a named person and time-stamped
Document control EU GMP Ch. 4 · 21 CFR 211 · PIC/S GMP Approval routes, current versions and older versions kept for reference
Training evidence 21 CFR 211.25 · EU GMP Ch. 2 Read-and-acknowledge records for every person on every version

Titan provides document controls that support these expectations. It is not a certification: compliance and system validation remain with your quality unit.

Your data stays in the region you chose. Titan follows your Microsoft 365 data location, whether that is the US, the EU, the UK, India, Australia or elsewhere.
D Training & Acknowledgement

Prove every person read the version that applies to them.

When an SOP changes, the right people are asked to read it, and you can show who did on request.

  • New versions sent to the right roles, departments and sites for acknowledgement
  • Read-and-acknowledge records for every person and every revision
  • Overdue reminders to staff and their managers
  • Acknowledgement reports ready to share with auditors
Training status · Rev 07
Line clearance before packaging
Packaging 62 of 62
QA 31 of 31
Production 55 of 59, 4 reminded
E The Inspection Desk

The inspector asks. You answer before the coffee goes cold.

These are the requests quality teams hear in almost every GMP inspection. Pick one and see how the answer comes together with and without a controlled system.

Common requests

The inspector asks“Which version of the line clearance SOP was effective when batch 24-0917 was released, and who was trained on it?”

Without a controlled system

  • Pull the paper binder, then check which revision was in it that month
  • Cross-check a training spreadsheet kept by each department
  • Email site QA to confirm, then wait

With Titan Workspace

  • (SOP-QA-014) opened from one search
  • Version history shows Rev 06 effective on the release date
  • Acknowledgement report lists every operator, with the date each signed

Version, effective date and training evidence on one screen.

The inspector asks“Your cleaning procedure changed last quarter. Show me the change control, the impact assessment and who approved it.”

Without a controlled system

  • Find the change form in a shared drive or an inbox
  • Match it to the SOP revision by hand
  • Track down approvers who have since moved roles

With Titan Workspace

  • Change control (CC-031) linked to the SOP revision
  • Impact assessment and reviewer comments attached
  • QA approval e-signed with name, date, time and meaning
  • Read-and-acknowledge sent when Rev 07 was released

One linked record from request to retraining.

Document numbers are examples. Your numbering, routes and sites are configured to match your quality system.

14M
documents under control at a single specialty chemical manufacturer.

Gujarat Fluorochemicals manages 14 million documents in Titan, all inside its own Microsoft 365 tenant. The same platform scales from one site's SOPs to an entire manufacturing network.

Read the full case study
  • Paper SOP binders replaced
  • Shared-drive folders replaced
  • Emailed approval forms replaced
  • Training spreadsheets replaced
  • One controlled system inside your tenant

Bharat Serums & Vaccines

Biopharmaceuticals

Focus
Biologics and specialty pharmaceuticals
Works with
Internal teams and external stakeholders
Titan modules
Document Management, Guest & Partner Portal
Runs in
Their own Microsoft 365 tenant

A biopharma manufacturer brought internal and external collaboration into one controlled place.

Teams across the business and outside partners needed to work on the same documents without files scattering across inboxes and personal drives. With Titan, documents are shared from one controlled source inside BSV's own tenant, with access set per person.

Titan Workspace has helped our employees to collaborate more efficiently with internal and external stakeholders.

Seenuvasan S.,Vice President & IT Head, Bharat Serums and Vaccines Limited

Pharmaceutical use cases

Automation of Change Request Management brings down internal cost and increases Productivity for a Wealth Management Company

Automation of Change Request Management brings down internal cost and increases Productivity for a Wealth Management Company

Read the case study

Automobile Manufacturing Giant Enhanced Document Security and Search Capabilities By 70% With Titan Workspace

Automobile Manufacturing Giant Enhanced Document Security and Search Capabilities By 70% With Titan Workspace

Read the case study

Crop protection leader automates travel request process for enhanced transparency

Crop protection leader automates travel request process for enhanced transparency

Read the case study

Why pharmaceutical teams choose Titan

GxP data never leaves your own Microsoft 365 tenant or the data region you chose

E-signatures, version history and full audit trails on every controlled document

Around 80% lower cost than building the same with custom SharePoint development

CMOs, CROs, suppliers and auditors join as guests, with no extra license per guest

No-code configuration: QA owns its workflows without waiting for developers

Works alongside your LIMS, MES, ERP and Microsoft Entra ID instead of replacing them

FAQ

Frequently Asked Questions

Pharmaceutical document control, quality workflows and partner access on Microsoft 365.

It is a controlled system for the documents a GMP operation runs on: SOPs, specifications, batch records, QC documents, change controls, deviations and CAPAs. Titan Workspace handles their review, approval, e-signature and acknowledgement inside your own Microsoft 365 tenant.

Titan gives you the document controls those rules look for: sign-in through your own Microsoft Entra ID, e-signatures, version history and time-stamped audit trails. It is not a certification on its own. Compliance and system validation remain with your quality unit, and our team can walk your QA and IT teams through how Titan is configured.

Ready for your next inspection?

Turn Microsoft 365 into an Inspection-Ready Quality Platform

If your SOPs, change controls, CAPAs or training records still move through binders, shared drives and email chains, Titan Workspace can change that, starting with a free pilot on your own tenant.

● No third-party cloud● Data stays in your M365 tenant● Free pilot on your tenant
Every batch. Every SOP. Nothing leaves home.