Maintenance plannings and budgets, intervals between verifications tests or calibrations, managing the available resource and sub suppliers as well as their levels of training and providing information to the management are some examples of tasks which must be conducted in a compliant way in regulated industries such as pharma and biotech, where everything must be documented.
CompuCal will facilitate maintenance plannings while improving
the efficiency of the instrumentation and qualification concerned
departments. The relevant costs will be reduced and the GxP rules
and guidelines will be respected, allowing the inspectors to clearly
follow any single fact of the complete lifecycle of the concerned
operational process measuring instruments and installed base.
critical features include:
- 1 CFR 11 compliant including full services
without loss of any historical data.
- Maintenance and calibration controls schedules, work
orders and reporting.
- SOP’s , drawings, safety sheets, loops diagrams and tags attachable.
- Seamless data transfer.
- Can issue and print certificates in accordance with ISO 170.
- Full records sheets for each tag.
- Multi locations and plants possible.
- E-mail controls system included.
- Electronic signatures with compliant ID and password.
- IQ & OQ available.
- Training of the users and operators.
- Reference list on request
Management reposting for costs analysis, historical
data, work due and overdue listings.