Schedule M documentation a small plant can keep current.

QualiGxP is a pharmaceutical DMS and QMS. This page maps how licensed QMS processes document revised Schedule M quality-system work for Indian SME manufacturers — not a folder assembled the week before inspection. Software does not certify the building, the HVAC, or the plant layout.

What this covers

Quality-system records. Not Premises engineering.

Schedule M Part I still requires suitable Premises, Plant, and equipment in the physical facility. QualiGxP helps the quality unit document the processes inspectors ask to see: change, deviation, CAPA, self-inspection, PQR, recall, laboratory events, qualification, calibration, competency, and the Site Master File.

QualiGxP does not certify a facility as Schedule M compliant. Customers validate intended use. Facility Premises, Plant, utilities, and physical equipment remain the site’s responsibility.

Sized for SME plants

One legal entity

Organisation identity on every controlled record

QA team of a few, not a few hundred

Signed transitions without an enterprise rollout

Inspection pack on demand

Gap summary, SOP sample, open-event counts

Export-ready underneath

ALCOA+ and attributable signatures for WHO / US / EU work

Ordered PQS coverage

From core quality events to inspector packs.

These are shipped QMS capabilities. CSV sits in the same entitlement so computerised systems used for GxP work have a signed release path.

Document control (DMS core)

SOPs, BMR/BPR, logs, forms, issuance, training before effective, and retention — the documentation backbone Schedule M assumes exists.

Change, deviation, investigation, CAPA

Linked quality-event lifecycles with attributable reasons, electronic signatures, private evidence, and effectiveness checks.

Complaints, self-inspection, QRM, suppliers, management review

The remaining PQS processes: complaint intake with Deviation or recall handoff, internal audits and findings, risk linked to quality events, supplier qualification, and management review with assembled inputs.

QRM event linkage

Risk assessments link to change, deviation, CAPA, complaint, audit finding, investigation, and CSV. Major and critical changes can require residual-risk gates.

Product Quality Review

Annual PQR by product and period, signed completion, and a path to spawn CAPA or change control from the review.

Market recall and returns

Recall and mock-recall distinct from DMS copy recall; complaint linkage; product returns with QA disposition.

Laboratory OOS / OOT

Phase I and Phase II rules, investigation and Deviation gates, and confirmed-closure evidence.

Equipment qualification and VMP

Validation Master Plan, equipment assets, and DQ/IQ/OQ/PQ plus process and cleaning qualification — separate from CSV of computerised systems.

Calibration and preventive maintenance

Schedules and work orders on assets; out-of-tolerance to Deviation; overdue calibration gates on critical assets.

Training and competency matrix

Role curricula tied to effective SOPs, requalification, and optional gates on execution and change-control approval.

Gap assessment, Site Master File, inspector packs

Schedule M Part I clause matrix, signed SMF publish, and an entitlement-gated export of SOP index, open quality-event counts, gap summary, CSV counts, and training sample.

PQS reporting and Schedule M readiness

Management-review suggested inputs, a Schedule M readiness dashboard, and quality-metrics coverage for overdue PQS work.

Computerised systems

CSV polish in the same QMS workspace.

Schedule M and WHO GMP expect computerised systems used in GxP processes to be validated. QualiGxP CSV projects carry intended use, requirements, specifications, risks, tests, executions, signed decisions, and independent QA release — with printable ALCOA+ traceability.

GxP assessment Signed decisions Independent QA release Periodic review Deviation closure gate

Walk through Schedule M coverage for your site.

Tell us whether you manufacture formulations or APIs, how many products you review annually, and where your current gap work stands.

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