Compliance for pharma and hospitals
GMP, GDP, Annex 11, 21 CFR Part 11 and the requirements of the Danish Medicines Agency rarely say "buy a monitoring system". They say that conditions must be under control and documented. Here is what that means in practice.
What do the rules require of a monitoring system?
That the environmental conditions affecting the product are measured continuously, that deviations are detected and handled, and that it can all be documented afterwards. In practice, this means calibrated sensors with traceable certificates, alarms that get through outside working hours, and a log that cannot be altered.
The system itself must also be validated, meaning it must be documented that it does what it is supposed to do. We carry out that validation, on our own or in close collaboration with your QA.
The specific scope is determined by your own risk assessment and your SOPs. We advise on the setup and carry out the validation according to the agreed scope.
Where is the line between us and you?
We supply the system, the documentation and the validation itself: audit trail, traceable calibration certificates, time-stamped measurements and reports, and IQ, OQ and PQ carried out by us, on our own or in close collaboration with your QA. You determine the scope based on your own risk assessment.
The requirements, one at a time
GMP
Good Manufacturing Practice. Requires that the conditions affecting product quality are under control and can be documented.
Production and QCRead more →
GDP
Good Distribution Practice. Requires that medicinal products are stored and transported within their temperature window.
Storage and transportRead more →
EU GMP Annex 11
The requirements for computerised systems. Validation, unaltered data, controlled access and audit trail.
The software itselfRead more →
21 CFR Part 11
US requirement for electronic records and signatures. Relevant for exports to the USA.
Exports to the USARead more →
Danish Medicines Agency requirements
What applies in Denmark to the storage of medicinal products, and what an inspection typically asks about.
DenmarkRead more →
Audit trail and data integrity
The ALCOA principles and why a log that can be altered is not documentation.
All areasRead more →
Inspection and documentation
What you need to be able to present, and how to pull it out of the system.
All areasRead more →
Validation, who does what
The line between supplier, customer and third party, explained without jargon.
All areasRead more →
Accredited calibration
Why traceability is not enough, and what accreditation covers.
All areasRead more →Frequently asked questions
Does a monitoring system make us compliant?
No. It provides the measurements and the documentation your compliance is built on. Whether your overall practice meets the requirements is decided by you and your QA.
Who carries out the validation?
We do, on our own or together with your QA. You determine the scope, and we carry out the validation and deliver the documentation.
Which requirements apply to us?
It depends on what you do and where you sell. Production and QC typically GMP, storage and distribution GDP, and exports to the USA also 21 CFR Part 11.
What is ALCOA?
A set of principles for data integrity: data must be attributable to a person, legible, contemporaneous, original and accurate. That is what an audit trail must meet.
Can the system meet 21 CFR Part 11?
OCEAView supports electronic records and signatures. Whether your overall setup meets the requirement is determined in the validation, which we carry out.
Where do we start?
With a walkthrough. We look at equipment and premises and tell you what the system can document. We agree the scope of the validation with your QA, and we carry it out.
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