Recently the pharma industry is filled with lots of consultants within their factories on various improvements to stay firm on the international quality demands. Improving internal quality systems has become a paramount concern for the top management. Traceability is driving pharma industry's quality chain, these systems once seen, as overheads are now the need of the hour. This need started generating lot of paper work, which everybody wanted to avoid.

Documentation is mainly of two categories: 1) Workflow documentation and 2) Reference documentation. The change control in documentation is one that is failing due the reimplementation issues.

Workflow Documentation: Documents like batch manufacturing records, analytical reports, material received note, issue slips, records, logs, protocols, GMP/ISO/ FDA related documents to name few. This list is very big in pharma industry! One can see the size of single batch docket to realize this.

Reference Documentation: SOPs (Standard Operating Procedures), quality manuals, policy manuals, Master Drug Files, various forms of workflow, guidelines, etc. again, a big list. They are very confidential too.

Traceability being the major objective of such documentation, we need to perceive it as necessity rather than a pain. Solution - a one time exercise to implement information technology.

It is the prerogative of the top management to partner with an IT solution provider, who will be an integral part of a high-level design of document management and contribute towards continuous compliance and automated systems. Documentation system is to be devised in such a way that it is fully automated and is an integral part of the workflow.

A Business Process Management (BPM) IT solution is ideally suited for Workflow Documentation. Typically, ERPs and/or integrated application software handle the workflow. If one can use this infrastructure to provide simultaneous documentation, lot of paper work would be reduced from employees. You can expect great appreciation from them.

(Scanned) Document Management System (DMS) is the best answer for Reference Documentation. DMS can handle change control, version control and workflow apart from achieving effective ease of reference.

When integrated together, these IT solutions can bring amazing change in the organization. If designed well, one can put apprehensions to rest about confidentiality.

A gift from the Top Management is "an integrated BPM & DMS Solution", which would bring a smile on your employees face.