Intelilab helps organize procedures, records, responsibilities, and follow-up routines for companies that are setting up a Quality System or reviewing an existing structure.
Some companies start with a few procedures and expand controls as the operation grows. Others already have a system in place but deal with outdated documents, overdue CAPAs, training that is hard to track, or processes that were changed without the corresponding documentation update.
There are also companies that need to build this structure for the first time.
The work starts with what exists today. We do not start from a ready-made package of procedures.
The system must allow the company to know who is responsible for each activity, which procedure is current, where the records are, how problems are handled, and which actions are still open.
It must also preserve the history of changes and allow management to track recurrences, delays, and relevant risks.
Depending on the scope, the work may involve:
Each document needs a clear purpose. Procedures explain how an activity should be carried out; records demonstrate what was done.
The structure must also define approval, review, current version, storage, retention, and access to records, according to the process and applicable requirements.
These three processes need to be connected.
A deviation may require investigation and lead to a corrective action. A CAPA may require a change to a procedure, system, equipment, or training. A change, in turn, may create new risks that need to be assessed before implementation.
Intelilab can review or structure these flows and the records used to track them.
Training must be linked to the activities each person performs.
The work may include a training matrix, version control, attendance records, handling of pending items, and assessment criteria when required by the process.
Not every supplier requires the same level of control.
We can help classify the service providers and materials that affect the operation, define qualification criteria, organize documents, and establish a re-evaluation routine.
Self-inspection helps find problems before a health inspection or external audit, but it must generate records and follow-up of actions.
Indicators should answer questions that are useful to management. Number of deviations, CAPA lead times, pending training, or problem recurrence are examples of information that can be tracked according to the company's situation.
A set of procedures may be up to date while the company still struggles to track deviations, training, or open actions.
For this reason, implementation does not end when the documents are approved. Owners, records, approval workflows, deadlines, and follow-up methods must be defined.
Depending on the project, deliverables may include:
A company without a structure needs to start with the essential processes and set an implementation sequence.
When the system already exists, we first assess what works. Useful documents and controls are kept; the work focuses on the gaps, redundancies, and processes that need to be corrected.
If the company does not yet know which parts of the system need revision, an assessment can be carried out before implementation.
This avoids starting by rewriting documents without understanding the problems that need to be solved.
When the company needs periodic follow-up, Quality Governance can organize indicators, open items, CAPAs, changes, and reviews with management.
We do not carry out implementation based only on generic documents. Procedures need to reflect the company's processes and responsibilities.
Yes. The revision can keep what is adequate and focus the work on what needs to change.
Yes. Owners and the people who carry out the processes need to take part in the decisions that affect day-to-day work.
Tell us how the company works today and which controls are already in place.