IndustriesPharmaceutical manufacturing
Pharmaceutical QMS software, configured from GMP
QMSdesk™ is pharmaceutical QMS software built from the GMP rules you're inspected against. Batch deviations, OOS results, changes and training run on signed workflows, so your QA team spends the day closing issues, not chasing them.
Usual profiles for this work
Regulations they carry
ISO 9001; ISO 31000:2018; 21 CFR Part 11; ALCOA+ data-integrity principles; 21 CFR Parts 210/211; EU GMP (EudraLex Vol. 4), including Annex 11; ICH Q10; ICH Q7; WHO GMP (Technical Report Series)
- Retention floor
- 10 years
- Event workflows
- 10, including Environmental excursion and Product recall
- Key deadline
- Batch deviation containment within 1 calendar day
A typical starting set. You choose your own profiles, and can add more at any time.
What a pharmaceutical manufacturer needs from an eQMS
Every batch-affecting issue contained fast, investigated properly and closed with proof, under signatures your QP and quality unit can stand behind.
Tuesday, 7:40 a.m
An operator on the filling line logs a batch deviation. Containment is due within one calendar day, and the record is already in QA's review queue. By Friday, the signed CAPA decision has raised the CAPA, and the change control and retraining it needs are on their way.
What the rules ask of you, and how QMSdesk supports it
GMP rules ask a medicine maker to prove three things: every batch problem was contained and investigated, every change was approved before it happened, and every person was trained on the current procedure. QMSdesk turns each of those into a signed workflow with a deadline, so the proof builds up as your team works, not in the week before an inspection.
| Regulation | What it asks of you | How QMSdesk supports it |
|---|---|---|
| FDA GMP (21 CFR Parts 210 and 211) and EU GMP (EudraLex Vol. 4) | How medicines are made, tested and released. | Batch deviations contained within 1 calendar day. OOS Phase 1 investigation within 1 business day. A Qualified Person (QP) role with approval rights over documents, changes and quality events. |
| ICH Q10 | A pharmaceutical quality system that keeps improving. | CAPA and change management run as connected systems. |
| ICH Q7 and WHO GMP | GMP for active pharmaceutical ingredients, and the WHO's GMP guidelines. | Carried by the same GMP profile, with nothing extra to set up. |
| 21 CFR Part 11 and EU GMP Annex 11 | Electronic records and signatures you can trust as much as paper. | A hash-chained audit trail, re-authentication at every signature, and periodic audit-trail review signed as reviewed. |
| Computer Software Assurance | A risk-based way to show the software is fit for use. | A validated core platform, and a written scope for the validation that stays yours. |
| EU GMP Annex 22 (draft) | Proposed rules for AI used in critical GMP work. | QMSdesk puts no AI model in any regulated decision path. |
Every customer also holds BASE, the quality baseline, which carries 21 CFR Part 11, ALCOA+, ISO 9001 and ISO 31000.
Your cGMP quality system: what the GMP profile turns on
A pharmaceutical or biologics manufacturer holds the GMP profile, alongside BASE.
- Event types. Batch deviation, environmental excursion and product recall, alongside the core event and CAPA workflows.
- Deadlines. Batch-deviation containment within 1 calendar day. OOS Phase 1 laboratory investigation within 1 business day. Complaint acknowledgment within 3 business days.
- Roles. Qualified Person (QP), QC Head, Production Head, Responsible Person (RP), Validation Engineer and Batch Release Specialist, next to the nine standard roles every organization gets.
- Retention floor in QMSdesk. 10 years.
The QP role arrives with approval rights over documents, changes and quality events. It's marked GxP-critical (critical to quality), so if a QP's training runs overdue, a risk opens.
Growing into new work? Add Contract operations when you manufacture for sponsors, or ATMP for cell and gene therapies. The strictest rule of every profile you hold applies, and existing records keep the rules they were created under.
Pharmaceutical QMS software modules that matter most
Deviation management
Minor deviations take a short path with one signature. Major and critical ones require containment, investigation, a signed CAPA decision and QA approval. A nonconformance disposition is signed, and use-as-is needs a technical rationale.
OOS/OOT investigations
Every out-of-specification result runs a Phase 1 laboratory investigation and a signed Phase 1 review, then Phase 2 when no lab error is found, following the FDA’s OOS guidance. Lab-error invalidations are trended by method, analyst and instrument.
CAPA
Approving the action plan raises the linked change control and training before implementation starts. After closure, an effectiveness check confirms the fix held, over the interval you set.
Change control
High-impact changes route to the Change Manager and the Quality Manager. Classification can raise the tier but never lower it. The requester never approves their own change, and the implementer never verifies their own work.
Document control
Author, reviewer and approver are always different people, and high-criticality documents need two approvers. An approved document takes effect after a 14-day grace period by default, with training assigned on approval.
Training management
Training is assigned on document approval, change, CAPA, new hire and role change. If training for a GxP-critical role runs overdue, a risk opens.
Every tier includes every module: document control, quality events, CAPA, change control, training, risk, audits, supplier quality, management review and reporting. See the whole platform
Build your regulatory profile
Start from manufacturing medicines and see your event types, roles, deadlines and minimum retention period. Add contract manufacturing or cell and gene therapy, and watch the strictest rules apply.
Questions buyers ask
Does QMSdesk handle batch deviations?
Yes. The GMP profile adds a batch-deviation event type on the deviation workflow, with containment due within one calendar day. Major and critical batch deviations need investigation, a signed CAPA decision and QA approval.
Can we run GMP alongside clinical trials or contract manufacturing?
Yes. Add the GCP or Contract operations profile, and QMSdesk combines them. You get the event types and roles of both, the shortest deadline and the longest minimum retention period. See CDMO and cell and gene therapy.
Does QMSdesk support 21 CFR Part 11 and EU GMP Annex 11?
QMSdesk is designed to support electronic-record and electronic-signature controls relevant to regulated use: a hash-chained audit trail kept insert-only by the database, re-authentication at every signature and segregation of duties. The certification under Part 11 §11.100(c) is yours to file with the FDA.
Who validates QMSdesk?
QMSdesk's core platform is validated under a QA-approved Validation Summary Report, and your system is validated by you. We'll walk you through the full record under a mutual NDA. Every engagement includes a written validation scope. See validation.
How is QMSdesk priced?
By organization tier, never per seat, and every tier includes every module. See pricing.
Your quality unit, one step ahead of every batch
Bring your last batch deviation or OOS result. We'll walk it through QMSdesk with you, from first report to proven fix.