Life sciences SOP software for ISO 13485, cGMP, and 21 CFR Part 11 programs
Medical device, pharmaceutical, and biotech teams use SOP Studio to manage controlled procedures, approval history, workforce acknowledgment, and electronic records — aligned with FDA and notified-body expectations.
Framework libraries included
Security & trust
Framework libraries are seeded control sets your team maps SOPs to — not certifications held by SOP Studio. SOC 2 Type II is in progress. See the Trust Center for the full production security posture.
Why procedures are different in life sciences
Documented procedures are the single most-inspected artifact in a 13485 or cGMP audit.
Notified bodies, FDA field investigators, and third-party assessors all open the same question: show me the current version of this procedure, prove it's been approved by the right person, and prove your workforce is trained on it.
That question sounds simple. In practice it's the hardest one for most quality teams to answer quickly. The current version is one of three files on a shared drive, the approver left the company eighteen months ago, the training record is a spreadsheet that hasn't been updated since the last audit, and the CAPA that prompted the revision lives in a different system entirely. SOP Studio replaces that patchwork with a single governed surface — and does it in a way that 21 CFR Part 11 auditors recognize as validated.
How SOP Studio helps
One controlled environment for every procedure your quality system depends on.
Mapped to ISO 13485, cGMP, and 21 CFR Part 11 out of the box. AI-assisted control mapping so your SOPs cross-walk into multiple frameworks simultaneously.
ISO 13485 QMS procedures
Written procedures mapped to ISO 13485 clauses — management responsibility, resource management, product realization (design control, purchasing, production, sterilization, traceability, preservation), and measurement/improvement (complaints, CAPA, internal audit, nonconforming product).
cGMP (21 CFR 210/211) batch discipline
Master production and control records, batch production records, QC unit responsibilities, and cleaning/maintenance procedures — each mapped to its Subpart and retained for the required period (at least 1 year post-expiration per §211.180).
21 CFR Part 11 — electronic records & signatures
Signature manifestations with record-linking, unique user identification, MFA-backed signing, time-stamped audit trails, and controls over identification codes and passwords. Each control ties back to the specific §11 subparagraph and a link to the eCFR text.
CAPA procedure linking
SOPs can reference CAPA records in your eQMS or SOP Studio itself. When a procedure is revised in response to a CAPA, the version history captures the link so auditors can trace root cause → procedural change → workforce retraining.
Design control procedures
Design planning, inputs, outputs, review, verification, validation, transfer, and change control procedures (13485 Clause 7.3) with review cycles timed to your design stage gates.
Supplier qualification procedures
Documented procedures for supplier evaluation, approval, and ongoing monitoring (13485 Clause 7.4). Evidence of supplier audits and risk-based verification lives alongside the procedure they support.
See it in the product
What inspection-ready procedures look like.
The same governed workflow your quality team runs every day is the evidence an FDA investigator or notified body asks for.
Frameworks we support
Map once, audit many. Procedures that satisfy 13485 usually also satisfy ISO 9001 or GMP — we make that explicit.
Frequently asked
Life sciences SOP management questions, answered.
Is SOP Studio a full eQMS for medical device or pharma?
SOP Studio is focused on the documented-procedure pillar of your quality system — SOPs, work instructions, forms, and the approval/acknowledgment/audit-trail around them. Full eQMS platforms also cover CAPA, complaints, change control, supplier quality, and design history files. SOP Studio integrates with several of those or can serve as the procedure layer inside them. Customers in early-stage device or pharma often start with SOP Studio as their first system of record and layer additional eQMS modules as they scale.
Does SOP Studio meet 21 CFR Part 11 requirements for electronic records and signatures?
SOP Studio provides the controls Part 11 calls for in §11.10 — system validation records, audit trails (who, what, when), access controls, authority checks, and record retention. For a Part 11-regulated workflow, customers typically (1) enroll in the pre-seeded 21 CFR Part 11 framework, (2) validate the system under their own validation plan using documentation we provide, and (3) configure retention and signature workflows to match their SOP. We do not assert Part 11 compliance as a blanket vendor claim — Part 11 compliance is a customer-specific assessment of how the system is validated and operated.
How does this work alongside our design history file (DHF) or device master record (DMR)?
SOP Studio is not a DHF/DMR repository. The procedures that govern design control, risk management, and manufacturing typically live in SOP Studio, while the design outputs themselves (drawings, specs, V&V protocols/reports) live in a PLM or document system. We link out to those artifacts from within each SOP so your surveyors see the full chain: approved procedure → linked design output.
Is this appropriate for GCP, GLP, GMP, or all three?
SOP Studio is built for documented-procedure workflows across the GxP umbrella. cGMP (21 CFR 210/211) is pre-seeded for pharmaceutical manufacturing. GCP and GLP customers use the same platform mapped against ICH GCP E6 or 21 CFR Part 58, respectively — those frameworks can be added as custom control sets (we can seed them if you need them).
Does SOP Studio replace training records or LMS software?
SOP Studio handles SOP-acknowledgment training — who read and signed off on each procedure, with a complete historical record of which version each employee acknowledged. Traditional LMS tools handle coursework and certifications (e.g. CITI, dedicated GxP courses). Most life-sciences customers use both and link them, using SOP Studio for procedure-level training records and an LMS for course-level training records.
Can we integrate with a GRC or eQMS tool we already use?
Yes. SOP Studio has an integration framework for pushing/receiving events with downstream systems. If your eQMS (MasterControl, Greenlight Guru, Veeva QualityDocs, etc.) is the system of record, SOP Studio can run as a drafting/review/acknowledgment surface that syncs approved procedures into the eQMS. Customers already on ISO 13485 often use this pattern so SOP Studio handles daily procedure work while the eQMS remains the regulatory record.
Stop losing audit days to procedure archaeology.
Book a walkthrough specific to your quality system — early-stage device, Class II manufacturer, commercial pharma, or contract research — and we'll show what 13485, cGMP, or Part 11 inspection day looks like with SOP Studio underneath.