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SÍ · Soluciones Integrales
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Systems and Compliance

From findings to an operational system.

We design or strengthen processes, documentation, and controls so your team can work with clear responsibilities and accessible evidence. We incorporate applicable requirements within the agreed scope.

When it makes sense.

When procedures go unused, documents lack controls, findings recur, growth is unstructured, or you need to prepare evidence for a review.

What it may include.

Quality and documentation.

Documentation structure, master list, SOPs, policies, forms, records, review, approval, and version control.

Processes and controls.

Process maps, responsibilities, traceability, control points, and metrics.

Correction and prevention.

Deviation records, root cause analysis, corrective and preventive actions, and effectiveness reviews.

Adoption.

Training, pilot implementation, support, and review of how documents and controls are used.

How the work progresses.

We review the current state; prioritize processes and requirements; design documents and controls; support the contracted rollout; and verify evidence of use and outstanding items.

Deliverables to agree on.

  • Implementation plan
  • Process map and process profiles
  • Responsibility matrix
  • Controlled documents
  • Compliance matrix where applicable
  • Action plan
  • Training materials
  • Follow-up records
  • Closeout report and outstanding items

Scope and limits.

The proposal defines the processes, sites, documentation volume, reviews, and support. The organization retains its operational and approval responsibilities. Certification audits, formal opinions, and regulated activities require the appropriate body or specialist.

Frequently asked questions

Can you work with what we already have?

Yes. We first assess what to retain, update, or replace.

Does it include management software?

Not automatically. If a tool is needed, its selection, licensing, and implementation are agreed separately.

Do you guarantee that we will pass an inspection?

No. The work focuses on identifying and addressing gaps within the agreed scope; the decision rests with the competent authority.

Make your system usable.

Tell us which processes and requirements you need to bring under control.