The PERL – PPMS is a smarter, leaner, cost effective, preventative maintenance, management planning tool. An alternative to expensive software packages that delivers a reliable Quality Compliant system which meets all regulatory requirements and expectations.

PERL – PPMS is a paper based Planned Preventative Maintenance System for Pharmaceutical and Biotechnology facilities, which will allow the formal maintenance assessment of equipment and instruments within systems. Rationale decision making tools are used, achieving full compliance with 21 CFR Part 210 & 211 and MHRA cGAMP guidelines.

PERL – PPMS uses an Access Database to generate Maintenance Assessment Forms, and Instrument Criticality Assessment Forms, which allows Calibration and Maintenance Job Plans to be created. The system provides Preventative Maintenance Scheduling of the approved Job Plans and is supported by a suite of custom written policies and procedures that can be integrated into existing Quality Systems.

Key features

  • A simple, robust, audit satisfying Planned Preventative Maintenance System that has been custom made for the pharmaceutical industry as a cost effective alternative to computer based systems
  • Suite of custom written Quality Policies and Procedures that accompany the system
  • Expertise and support throughout the project including a full training package and aftercare service
  • The system has a proven track record and will meet all regulatory requirements from FDA to MHRA
  • Maintenance review process provides documented evidence and justification rationale why maintenance and calibration is, or is not required

What can PERL–PPMS it do for you?

PERL – PPMS offers an easy to understand system enabling Planned Preventative Maintenance to be created by the population of a bespoke Access Database. The Database is used to hold all the equipment location numbers, equipment information, make, model number and spare parts. It is also used to generate Maintenance Assessment Forms (MAFs), Criticality Assessment Forms (CAF’s), Maintenance Job Plans and Calibration Job Plans. A monthly paper based PPM schedule is generated by the Database for approval at the beginning of each month, listing all Job Plans due to be performed.

In order to implement the PERL–PPMS, a facility is split into defined systems. An individual Maintenance Assessment is carried out on each identified piece of equipment within a system. A rationale table is used to determine whether maintenance is or is not required and this is recorded and approved on the Maintenance Assessment Forms. Scheduled maintenance documents, called ‘Maintenance Job Plans’ (MJPs), are then created from the Maintenance Assessments. The MJPs list scheduled work that needs to be carried out on a routine basis. They are then integrated into the PPMS schedule.
Each approved MJP is used to record planned maintenance.

Instruments are assessed as part of the Instrument Criticality Assessment process. These assessments are carried out for every instrument that is involved in the operation of the facility. Criticality Assessment Forms (CAFs) are approved paper documents used to assess instrument criticality – information that is recorded and approved on the CAF is used to generate the Calibration Job Plans (CJP). All documents are generated from the Database and are approved and scanned as PDFs.

Business Benefits of PERL–PPMS

  • The PERL - PPMS needs limited upgrading or maintenance, reducing running costs
  • The PPMS shows compliance through the use of paper generated documents
  • Provides evidence and justification of why maintenance is or isn’t required
  • A highly effective system which will deliver a robust, leaner, efficient facility, reducing downtime of equipment and minimising breakdowns